Parallel Import MR-DC List...Parallel Import MR-DC List Procedure No Source Country ECMA No Imported Name UK PL No UK Product DE/H/0523/001 Austria 1-26158 Olmetec Plus 20mg/12.5mg

Parallel Import MR-DC List

Procedure No Source Country ECMA No Imported Name UK PL No UK ProductDE/H/0769/002 Austria 1-18153 Capozide Forte Tabletten 00034/0263 Capozide tabsSE/H/0404/002 Austria 1-18172 Renitec 5 mg Tabletten 00025/0194 Innovace 5mg tabsSE/H/0404/003 Austria 1-18173 Renitec 10mg tabeltten 00025/0195 Innovace 10mg tabsIE/H/0716/005 Austria 1-19105 Zinnat 500mg filmtabletten 10949/0119 Zinnat 500mg tabsIE/H/0716/004 Austria 1-19106 Zinnat 250mg filmtabletten 10949/0096 Zinnat 250mg tabsNL/H/2081/002 Austria 1-19207 Losec 20mg magensaftresistente Kapseln 17901/0133 Losec 20mg capsDE/H/4019/002 Austria 1-20689 Sandimmun Neoral 25mg kapseln 00101/0387 Neoral 25mg soft capsDE/H/4019/003 Austria 1-20690 Sandimmun Neoral 50mg kapseln 00101/0388 Neoral 50mg soft capsDE/H/4019/004 Austria 1-20691 Sandimmun Neoral 100mg kapseln 00101/0389 Neoral 100mg soft capsDE/H/4019/005 Austria 1-20694 Sandimmun Neoral 100mg/ml trinklosung 00101/0390 Neoral 100mg/ml solutionNL/H/2081/001 Austria 1-20934 Losec 10mg magensaftresistente Kapseln 17901/0132 Losec 10mg capsNL/H/1457/002 Austria 1-21306 Cosaar 50mg filmtabletten 00025/0324 Cozaar 50mg tabsNL/H/3915/004 Austria 1-21365 Durogesic 75 Mikrogramm/Stunde - Transdermales Pflaster 00242/0194 Durogesic DTrans 75ug/hrNL/H/3915/005 Austria 1-21366 Durogesic 100 Mikrogramm/Stunde - Transdermales Pflaster 00242/0195 Durogesic DTrans 100ug/hrNL/H/3915/002 Austria 1-21367 Durogesic 25 Mikrogramm/Stunde - Transdermales Pflaster 00242/0192 Durogesic DTrans 25ug/hrNL/H/3915/003 Austria 1-21376 Durogesic 50 Mikrogramm/Stunde - Transdermales Pflaster 00242/0193 Durogesic DTrans 50ug/hrIE/H/0165/002 Austria 1-21633 Prograf 1mg Hartkapseln 00166/0203 Prograf 1mg hard capsNL/H/0101/001 Austria 1-21662 Amaryl 1mg Tabletten 17780/0619 Amaryl 1mg tabsNL/H/0101/002 Austria 1-21664 Amaryl 2mg Tabletten 17780/0620 Amaryl 2mg tabsNL/H/0101/004 Austria 1-21665 Amaryl 4mg Tabletten 17780/0622 Amaryl 4mg tabsNL/H/0101/003 Austria 1-21666 Amaryl 3mg Tabletten 17780/0621 Amaryl 3mg tabsNL/H/1458/001 Austria 1-21713 Cosaar plus 50 mg/12,5 mg Filmtabletten 00025/0338 Cozaar Comp 50mg/12.5mgNL/H/4790/001 Austria 1-21844 Zanedip 10mg filmtabletten 04595/0005 Zanidip 10mg tabsSE/H/0121/002 Austria 1-21896 Oxis Turbohaler 12μg - Dosier-Pulverinhalator 17901/0153 Oxis Turbohaler 12SE/H/0121/001 Austria 1-21897 Oxis Turbohaler 12μg - Dosier-Pulverinhalator 17901/0154 Oxis Turbohaler 6DE/H/6220/001 Austria 1-21997 Malarone 250 mg/100 mg Filmtabletten 10949/0258 Malarone tabsDE/H/6157/001 Austria 1-22019 Xalatan 0.005% Augentropfen 00057/1057 Xalatan eye dropsIE/H/0838/001 Austria 1-22084 Sporanox 10 mg/ml Lösung zum Einnehmen 00242/0307 Sporanox LiquidPT/H/2363/001 Austria 1-22152 Augmentin 400mg/57mg/5ml Pulver zur Herstellung einer Suspension zum Einnehmen10592/0070 Augmentin Duo 400/57SE/H/1821/001 Austria 1-22208 Nasonex aquosum - Nasenspray 00025/0587 Nasonex 50ug/actuation nasal sprayNL/H/0566/003 Austria 1-22309 Seroxat 2mg/ml 10592/0092 Seroxat 20mg/10ml suspSE/H/0139/001 Austria 1-22389 Detrusitol 1mg filmtabletten 50622/0015 Detrusitol 1mg tabsSE/H/0139/002 Austria 1-22390 Detrusitol 2mg filmtabletten 50622/0016 Detrusitol 2mg tabsSE/H/0565/001 Austria 1-22463 Co-Diovan 80 mg/12,5 mg - Filmtabletten 00101/0480 Co-Diovan 80/12.5mg tabsNL/H/0144/001 Austria 1-22636 Maxalt 5mg Tabletten 00025/0369 Maxalt 5mg tabsNL/H/0144/002 Austria 1-22637 Maxalt 10mg Tabletten 00025/0370 Maxalt 10mg tabsNL/H/0144/004 Austria 1-22639 Maxalt Rapitab 10mg – Lyotabletten 00025/0372 Maxalt Melt 10mgPT/H/2325/002 Austria 1-22682 Tanatril 5mg Tabletten 20012/0004 Tanatril 5mg tabsPT/H/2325/004 Austria 1-22683 Tanatril 20mg Tabletten 20012/0006 Tanatril 20mg tabsPT/H/2325/003 Austria 1-22684 Tanatril 10mg Tabletten 20012/0005 Tanatril 10mg tabsDE/H/5916/001 Austria 1-22842 Isotrexin Gel 19494/0068 Isotrexin GelSE/H/0169/003 Austria 1-22900 Seretide Diskus forte 50 Mikrogramm/500 Mikrogramm - einzeldosiertes Pulver zur Inh 10949/0316 Seretide 500 AccuhalerSE/H/0169/002 Austria 1-22901 Seretide Diskus standard 50 Mikrogramm/250 Mikrogramm - einzeldosiertes Pulver zu 10949/0315 Seretide 250 AccuhalerSE/H/0169/001 Austria 1-22902 Seretide Diskus levis 50 Mikrogramm/100 Mikrogramm - einzeldosiertes Pulver zur Inh 10949/0314 Seretide 100 AccuhalerNL/H/1457/001 Austria 1-22927 Cosaar 12.5mg filmtabletten 00025/0515 Cozaar 12.5mg tabsNL/H/0150/001 Austria 1-22964 Implanon NXT 68 mg Implantat zur subkutanen Anwendung 00025/0563 NexplanonNL/H/0156/001 Austria 1-23460 Seroquel 25mg filmtabletten 50827/0002 Seroquel 25mg tabsNL/H/0156/002 Austria 1-23461 Seroquel 100mg filmtabletten 50827/0003 Seroquel 100mg tabs

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductNL/H/0156/003 Austria 1-23463 Seroquel 200mg filmtabletten 50827/0004 Seroquel 200mg tabsSE/H/0198/001 Austria 1-23601 Celebrex 100mg hartkapseln 50622/0011 Celebrex 100mg capsDE/H/0116/003 Austria 1-23741 Lescol MR 80mg filmtabletten 00101/0587 Lescol XL 80mg tabsAT/H/0754/001 Austria 1-23836 Lovenox 12.000IE (120mg)/0,8ml Injektionslösung in einer Fertigspritze 04425/0185 Clexane Forte 12000IU (120mg)/0.8mlAT/H/0754/002 Austria 1-23837 Lovenox 15.000IE (150mg)/1ml Injektionslösung in einer Fertigspritze 04425/0185 Clexane Forte 15000IU (150mg)/1mlNL/H/2280/001 Austria 1-23915 Femoston conti 1mg/5mg filmtabletten 46302/0038 Femoston-Conti 1mg/5mg tabsDE/H/5770/001 Austria 1-23942 Seretide levis 25 Mikrogramm/50 Mikrogramm pro Sprühstoß 10949/0337 Seretide 50 EvohalerDE/H/5770/002 Austria 1-23943 Seretide standard 25 Mikrogramm/125 Mikrogramm pro Sprühstoß 10949/0338 Seretide 125 EvohalerDE/H/5770/003 Austria 1-23944 Seretide forte 25 Mikrogramm/250 Mikrogramm pro Sprühstoß 10949/0339 Seretide 250 EvohalerNL/H/1458/003 Austria 1-23960 Fortzaar 100mg/25mg filmtabletten 00025/0374 Cozaar Comp 100mg/25mgSE/H/0229/001 Austria 1-23993 Symbicort Turbohaler 160 Mikrogramm/4,5 Mikrogramm pro Dosis Pulver zur Inhalation17901/0092 Symbicort 200/6 TurbohalerSE/H/0230/001 Austria 1-23994 Symbicort mite Turbohaler 80 Mikrogramm/4,5 Mikrogramm pro Dosis Pulver zur Inhala17901/0091 Symbicort 100/6 TurbohalerSE/H/0225/001 Austria 1-23998 Zaditen 0.025% Augentropfen 20162/0019 Zaditen 0.25mg/ml eye dropsFR/H/0171/001 Austria 1-24000 Diamicron MR 30mg Tabletten mit veranderter Wirkstofffreisetzung 05815/0019 Diamicron 30mg MR tabsFR/H/0178/001 Austria 1-24094 FemSevenCombi 50 Mikrogramm/10 Mikrogramm/24 Stunden - Depot-Pflaster 49876/0011 FemSeven Sequi patchesNL/H/4583/002 Austria 1-24155 Relpax 40mg filmtabletten 50622/0054 Relpax 40mg tabsSE/H/0249/001 Austria 1-24204 Xalacom 50 Mikrogramm/ml+5mg/ml Augentropfen 00057/1056 Xalacom eye dropsDE/H/0299/001 Austria 1-24226 Xyzall 5mg Filmtabletten 00039/0539 Xyzal 5mg tabsNL/H/1457/003 Austria 1-24232 Cosaar 100mg Filmtabletten 00025/0416 Cozaar 100mg tabsDE/H/5646/001 Austria 1-24273 Caverject Dual 10 µg - Zweikammerzylinderampullen 00057/0939 Caverject DCS 10ugDE/H/5646/002 Austria 1-24274 Caverject Dual 20 µg - Zweikammerzylinderampullen 00057/0940 Caverject DCS 20ugSE/H/0406/003 Austria 1-24275 Diovan 80mg filmtabletten 00101/0600 Diovan 80mg tabsSE/H/0406/004 Austria 1-24276 Diovan 160mg filmtabletten 00101/0601 Diovan 160mg tabsNL/H/0156/007 Austria 1-24319 Seroquel 300mg filmtabletten 50827/0005 Seroquel 300mg tabsDE/H/0307/001 Austria 1-24396 Transtec 35 Mikrogramm/h – transdermales Pflaster 04539/0014 Transtec 35ug/hr patchDE/H/0307/002 Austria 1-24397 Transtec 52.5 Mikrogramm/h – transdermales Pflaster 04539/0015 Transtec 52.5ug/hr patchDE/H/0307/003 Austria 1-24398 Transtec 70 Mikrogramm/h – transdermales Pflaster 04539/0016 Transtec 70ug/hr patchNL/H/0299/001 Austria 1-24507 Spiriva 18 mikrogramm kapseln mit inhalationspulver 14598/0062 Spiriva 18mcg inhalation powderSE/H/0147/001 Austria 1-24660 Cerazette 75 mikrogramm filmtabletten 00025/0562 Cerazette 75mcg tabsSE/H/0229/002 Austria 1-24739 Symbicort forte Turbohaler 320 Mikrogramm/9 Mikrogramm pro Dosis Pulver zur Inhala17901/0200 Symbicort 400/12 TurbohalerDE/H/0384/001 Austria 1-24926 Olmetec 10 mg Filmtabletten 08265/0015 Olmetec 10mg tabsDE/H/0384/002 Austria 1-24927 Olmetec 20 mg Filmtabletten 08265/0016 Olmetec 20mg tabsDE/H/0384/003 Austria 1-24928 Olmetec 40 mg Filmtabletten 08265/0017 Olmetec 40mg tabsDE/H/5854/001 Austria 1-24961 Solaraze 3% gel 16973/0012 Solaraze 3% gelSE/H/0565/002 Austria 1-25101 Co-Diovan forte 160 mg/12,5 mg - Filmtabletten 00101/0650 Co-Diovan 160/12.5mg tabsFI/H/0313/001 Austria 1-25516 Nebido 1000mg/4ml Injektionslösung 00010/0549 Nebido 1000mg/4ml injNL/H/0506/001 Austria 1-25566 INSPRA 25mg Filmtabletten 50622/0028 Inspra 25mg tabsNL/H/0506/002 Austria 1-25567 INSPRA 50mg Filmtabletten 50622/0029 Inspra 50mg tabsSE/H/0565/003 Austria 1-25735 Co-Diovan fortissimum 160 mg/25 mg - Filmtabletten 00101/0651 Co-Diovan 160/25mg tabsSE/H/0210/005 Austria 1-25737 Reminyl 8 mg Retardkapseln 08557/0052 Reminyl XL 8mg capsSE/H/0210/007 Austria 1-25739 Reminyl 24 mg Retardkapseln 08557/0054 Reminyl XL 24mg capsSE/H/0406/005 Austria 1-25945 Diovan 40mg filmtabletten 00101/0599 Diovan 40mg tabsNL/H/3915/001 Austria 1-26080 Durogesic 12 Mikrogramm/Stunde - Transdermales Pflaster 00242/0409 Durogesic DTrans 12ug/hrDE/H/0523/001 Austria 1-26158 Olmetec Plus 20mg/12.5mg Filmtabletten 08265/0022 Olmetec Plus 20mg/12.5mg tabsDE/H/0523/002 Austria 1-26159 Olmetec Plus 20mg/25mg Filmtabletten 08265/0023 Olmetec Plus 20mg/25mg tabsNL/H/4790/002 Austria 1-26285 Zanidip 20mg filmtabletten 04595/0010 Zanidip 20mg tabsFR/H/0272/001 Austria 1-26327 Noax uno 100mg Retardtabletten 43808/0001 Tradorec XL 100mg tabsFR/H/0272/002 Austria 1-26329 Noax uno 200mg Retardtabletten 43808/0002 Tradorec XL 200mg tabs

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductFR/H/0272/003 Austria 1-26331 Noax uno 300mg Retardtabletten 43808/0003 Tradorec XL 300mg tabs

DK/H/0134/002 Austria 1-26570 Cosopt sine 20mg/ml + 5mg/ml Augentropfen 16058/0015 Cosopt SDUDE/H/4019/001 Austria 1-26595 Sandimmun Neoral 10mg kapseln 00101/0483 Neoral 10mg soft capsSE/H/1876/001 Austria 1-26720 Serevent Evohaler Dosieraerosol 10949/0369 Serevent 25 EvohalerDE/H/0690/004 Austria 1-26725 Medikinet retard 10 mg Hartkapseln mit veränderter Wirkstofffreisetzung 11243/0005 Medikinet XL 10mg capsDE/H/0690/005 Austria 1-26726 Medikinet retard 20 mg Hartkapseln mit veränderter Wirkstofffreisetzung 11243/0006 Medikinet XL 20mg capsDE/H/0690/006 Austria 1-26727 Medikinet retard 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung 11243/0007 Medikinet XL 30mg capsDE/H/0690/007 Austria 1-26728 Medikinet retard 40 mg Hartkapseln mit veränderter Wirkstofffreisetzung 11243/0008 Medikinet XL 40mg capsNL/H/0732/001 Austria 1-26880 Mezavant 1200mg magensaftresistente Retardtabletten 08081/0040 Mezavant XL 1200mg tabsSE/H/0406/006 Austria 1-26881 Diovan 320mg filmtabletten 00101/0726 Diovan 320mg tabsDE/H/0871/001 Austria 1-27002 Foster 100/6 Mikrogramm/Sprühstoß, Druckgasinhalation, Lösung 08829/0156 Fostair 100/6 inhalerNL/H/0718/001 Austria 1-27222 Spiriva Respimat 2,5 Mikrogramm - Lösung zur Inhalation 14598/0084 Spiriva RespimatNL/H/0156/011 Austria 1-27419 Seroquel XR 400mg retardtabletten 50827/0010 Seroquel XL 400mg tabsNL/H/0156/008 Austria 1-27420 Seroquel XR 50mg retardtabletten 50827/0006 Seroquel XL 50mg tabsNL/H/0156/009 Austria 1-27421 Seroquel XR 200mg retardtabletten 50827/0008 Seroquel XL 200mg tabsNL/H/0156/010 Austria 1-27422 Seroquel XR 300mg retardtabletten 50827/0009 Seroquel XL 300mg tabsSE/H/1861/001 Austria 1-27507 Alvesco 80 mikrogramm dosieraerosol 17901/0297 Alvesco 80 inhalerSE/H/1861/002 Austria 1-27508 Alvesco 160 mikrogramm dosieraerosol 17901/0298 Alvesco 160 inhalerDE/H/0221/002 Austria 1-28100 uriVesc 60mg retardkapseln 46302/0194 Regurin XL 60mg capsNL/H/0156/012 Austria 1-28377 Seroquel XR 150mg retardtabletten 50827/0007 Seroquel XL 150mg tabsSE/H/1984/001 Austria 1-28434 Oraycea 40 mg Hartkapseln mit veränderter Wirkstofffreisetzung 10590/0056 Efracea 40mg capsDE/H/5733/001 Austria 1-29025 Versatis 700mg wirkstoffhaltiges Pflaster 21727/0016 Versatis 700mg medicated plasterDE/H/0523/003 Austria 1-29037 Olmetec Plus 40mg/12.5mg Filmtabletten 08265/0029 Olmetec Plus 40mg/12.5mg tabsDE/H/0523/004 Austria 1-29038 Olmetec Plus 40mg/25mg Filmtabletten 08265/0030 Olmetec Plus 40mg/25mg tabsDE/H/2251/001 Austria 1-29401 Duodart 0.5mg/0.4mg Hartkapseln 19494/0046 Combodart 0.5mg/0.4mg capsNL/H/2280/002 Austria 1-29404 Femoston conti 0.5mg-2.5mg 46302/0037 Femoston-Conti 0.5mg/2.5mg tabsDK/H/2871/001 Austria 1-29491 Picoprep 03194/0014 PicolaxSE/H/0908/001 Austria 1-29805 Jext 150 mikrogramm injektionslosung in einem Fertigpen 10085/0052 Jext 150mcg PenSE/H/0908/002 Austria 1-29806 Jext 300 mikrogramm injektionslosung in einem Fertigpen 10085/0053 Jext 300mcg PenDE/H/0690/008 Austria 1-30056 Medikinet retard 5 mg Hartkapseln mit veränderter Wirkstofffreisetzung 11243/0010 Medikinet XL 5mg capsDE/H/2915/001 Austria 1-30982 Latanoprost Pfizer 50 Mikrogramm/ml Augentropfen 00057/1221 Latanoprost Pfizer 50ug/ml eye dropsDE/H/2020/004 Austria 1-31064 Palexia retard 50mg 21727/0041 Palexia SR 50mg tabsDE/H/2020/005 Austria 1-31065 Palexia retard 100mg 21727/0042 Palexia SR 100mg tabsDE/H/2020/006 Austria 1-31066 Palexia retard 150mg 21727/0043 Palexia SR 150mg tabsDE/H/2020/007 Austria 1-31067 Palexia retard 200mg 21727/0044 Palexia SR 200mg tabsDE/H/2020/008 Austria 1-31068 Palexia retard 250mg 21727/0045 Palexia SR 250mg tabsDK/H/0279/002 Austria 1-31155 Daivobet 50 mikrogramm/g + 0,5 mg/g gel 05293/0005 Dovobet gelSE/H/1074/001 Austria 1-31177 Latanoprost/Timolol Pfizer 50 Mikrogramm/ml + 5 mg/ml Augentropfen 00057/1322 Latanoprost/Timolol Pfizer 50+5 ug/mlSE/H/1079/004 Austria 1-31393 Santizor 4 mg Retardkapseln 00057/1259 Santizor XL 4mg capsSE/H/1079/004 Austria 1-31393 Santizor 4mg Retardkapseln 00057/1259 Santizor XL 4mg capsDE/H/0871/002 Austria 1-31744 Foster Nexthaler 100 Mikrogramm/6 Mikrogramm pro Dosis Pulver zur Inhalation 08829/0173 Fostair Nexthaler 100/6DE/H/3355/001 Austria 1-31812 Dymista 137 Mikrogramm/50 Mikrogramm pro Sprühstoß Nasenspray, Suspension 15142/0258 Dymista Nasal SprayNL/H/2498/001 Austria 1-35232 Striverdi Respimat 2,5 14598/0093 Striverdi Respimat DK/H/0134/003 Austria 1-38436 Cosopt sine multidose 20mg/ml + 5mg/ml Augentropfen, Lösung 16058/0025 Cosopt iMultiSE/H/0404/002 Belgium 129997 Renitec 5mg comprimes 00025/0194 Innovace 5mg tabsDE/H/3456/008 Belgium 160413 Diflucan 40mg/ml poudre pour suspension buvable 00057/0344 Diflucan 40mg/ml oral suspensionDE/H/3456/005 Belgium 160422 Diflucan 10 mg/ml poudre pour suspension buvable 00057/0343 Diflucan 10mg/ml oral suspensionDE/H/4019/002 Belgium 170642 Neoral-Sandimmun 25mg capsules molles 00101/0387 Neoral 25mg soft caps

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductDE/H/4019/004 Belgium 170676 Neoral-Sandimmun 100mg capsules molles 00101/0389 Neoral 100mg soft capsDE/H/4019/005 Belgium 170685 Neoral-Sandimmun 100mg/ml solution buvable 00101/0390 Neoral 100mg/ml solutionDE/H/4019/003 Belgium 170764 Neoral-Sandimmun 50mg capsules molles 00101/0388 Neoral 50mg soft capsNL/H/1457/002 Belgium 173074 Cozaar 50mg comprimés pelliculés 00025/0324 Cozaar 50mg tabsNL/H/3915/005 Belgium 177834 Durogesic 100 microgrammes/heure, dispositif transdermique 00242/0195 Durogesic DTrans 100ug/hrNL/H/3915/003 Belgium 177886 Durogesic 50 microgrammes/heure, dispositif transdermique 00242/0193 Durogesic DTrans 50ug/hrNL/H/3915/004 Belgium 177895 Durogesic 75 microgrammes/heure, dispositif transdermique 00242/0194 Durogesic DTrans 75ug/hrNL/H/3915/002 Belgium 177904 Durogesic 25 microgrammes/heure, dispositif transdermique 00242/0192 Durogesic DTrans 25ug/hrDE/H/6157/001 Belgium 183967 Xalatan 0,005% collyre en solution 00057/1057 Xalatan eye dropsSE/H/0110/003 Belgium 184371 Topamax 100mg tabletten 00242/0303 Topamax 100mg tabsSE/H/0110/001 Belgium 184405 Topamax 25mg tabletten 00242/0301 Topamax 25mg tabsDE/H/3259/001 Belgium 184746 Provigil 100 mg comprimés 14776/0098 Provigil 100mg tabsSE/H/0121/002 Belgium 185954 Oxis Turbohaler 9mcg 17901/0153 Oxis Turbohaler 12SE/H/0121/001 Belgium 185963 Oxis Turbohaler 4.5mcg 17901/0154 Oxis Turbohaler 6DE/H/6220/001 Belgium 186821 Malarone 250 mg/100 mg comprimés pelliculés 10949/0258 Malarone tabsIE/H/0838/001 Belgium 190294 Sporanox 10mg/ml solution buvable 00242/0307 Sporanox LiquidSE/H/1821/001 Belgium 190854 Nasonex 50 microgrammes par pulvérisation, suspension pour pulvérisation nasale 00025/0587 Nasonex 50ug/actuation nasal sprayNL/H/1458/001 Belgium 190915 Cozaar Plus 50mg/12,5mg comprimés pelliculés 00025/0338 Cozaar Comp 50mg/12.5mgSE/H/0565/001 Belgium 192893 Co-Diovane 80 mg/12,5 mg comprimés pelliculés 00101/0480 Co-Diovan 80/12.5mg tabsDE/H/4690/002 Belgium 195921 Tazko 5mg/5mg comprimés à libération prolongée 04425/0320 Triapin 5mg/5mg PR tabsSE/H/0147/001 Belgium 196506 Cerazette 75 microgrammes comprimé pelliculé 00025/0562 Cerazette 75mcg tabsDE/H/4019/001 Belgium 196953 Neoral-Sandimmun 10mg capsules molles 00101/0483 Neoral 10mg soft capsNL/H/0144/004 Belgium 197312 Maxalt Lyo 10mg lyophilisats oraux 00025/0372 Maxalt Melt 10mgSE/H/0169/001 Belgium 200855 Seretide Diskus 50 microgram/100 microgram/dosis, inhalatiepoeder, voorverdeeld 10949/0314 Seretide 100 AccuhalerSE/H/0169/002 Belgium 200873 Seretide Diskus 50 microgram/250 microgram/dosis, inhalatiepoeder, voorverdeeld 10949/0315 Seretide 250 AccuhalerSE/H/0169/003 Belgium 200882 Seretide Diskus 50 microgram/500 microgram/dosis , inhalatiepoeder, voorverdeeld 10949/0316 Seretide 500 AccuhalerNL/H/1457/001 Belgium 201144 Cozaar 12.5mg comprimés pelliculés 00025/0515 Cozaar 12.5mg tabsNL/H/0150/001 Belgium 203271 Implanon NXT, 68 mg implant pour usage sous-cutané 00025/0563 NexplanonSE/H/0110/008 Belgium 207435 Topamax 25mg harde capsules 00242/0349 Topamax Sprinkle 25mg capsSE/H/0110/009 Belgium 207444 Topamax 50mg harde capsules 00242/0350 Topamax Sprinkle 50mg capsNL/H/0156/001 Belgium 210357 Seroquel 25mg comprimés pelliculés 50827/0002 Seroquel 25mg tabsNL/H/0156/002 Belgium 210366 Seroquel 100mg comprimés pelliculés 50827/0003 Seroquel 100mg tabsNL/H/0156/003 Belgium 210375 Seroquel 200mg comprimés pelliculés 50827/0004 Seroquel 200mg tabsSE/H/0198/001 Belgium 212301 Celebrex 100mg hartkapseln 50622/0011 Celebrex 100mg capsSE/H/0198/002 Belgium 212317 Celebrex 200mg harde capsules 50622/0012 Celebrex 200mg capsSE/H/0211/001 Belgium 215826 Nexiam 20mg gastro-resistant tablet 17901/0068 Nexium 20mg tabsSE/H/0211/002 Belgium 215887 Nexiam 40mg 17901/0069 Nexium 40mg tabsSE/H/0229/001 Belgium 220534 Symbicort Turbohaler 160 microgrammes/4,5 microgrammes/inhalation, poudre pour in17901/0092 Symbicort 200/6 TurbohalerDE/H/5770/001 Belgium 220683 Seretide 25 microgram/50 microgram/dosis Aerosol, suspensie 10949/0337 Seretide 50 EvohalerDE/H/5770/002 Belgium 220692 Seretide 25 microgram/125 microgram/dosis Aerosol, suspensie 10949/0338 Seretide 125 EvohalerDE/H/5770/003 Belgium 220701 Seretide 25 microgram/250 microgram/dosis Aerosol, suspensie 10949/0339 Seretide 250 EvohalerSE/H/0249/001 Belgium 226597 Xalacom 50 microgrammes/ml + 5 mg/ml, collyre en solution 00057/1056 Xalacom eye dropsDE/H/0299/001 Belgium 228505 Xyzall 5mg, comprimés pelliculés 00039/0539 Xyzal 5mg tabsNL/H/0156/007 Belgium 228907 Seroquel 300mg comprimés pelliculés 50827/0005 Seroquel 300mg tabsNL/H/1458/003 Belgium 229302 Cozaar Plus Forte 100mg/25mg comprimés pelliculés 00025/0374 Cozaar Comp 100mg/25mgAT/H/0754/001 Belgium 230176 Clexane 12000IU (120mg/0.8ml) 04425/0185 Clexane Forte 12000IU (120mg)/0.8mlAT/H/0754/002 Belgium 230185 Clexane 15000IU (150mg/1ml) 04425/0185 Clexane Forte 15000IU (150mg)/1mlDE/H/0307/001 Belgium 233956 Transtec 35 microgrammes/h dispositif transdermique 04539/0014 Transtec 35ug/hr patch

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductDE/H/0307/002 Belgium 233965 Transtec 52,5 microgrammes/h dispositif transdermique 04539/0015 Transtec 52.5ug/hr patchDE/H/0307/003 Belgium 233974 Transtec 70 microgrammes/h dispositif transdermique 04539/0016 Transtec 70ug/hr patchNL/H/1457/003 Belgium 235627 Cozaar 100mg comprimés pelliculés 00025/0416 Cozaar 100mg tabsNL/H/0299/001 Belgium 236047 Spiriva 18 microgrammes poudre pour inhalation en gélule 14598/0062 Spiriva 18mcg inhalation powderDK/H/0279/001 Belgium 239303 Dovobet 50µg/g; 0,5mg/g ointment 05293/0003 Dovobet ointmentSE/H/0229/002 Belgium 239741 Symbicort forte Turbohaler 320 microgrammes/9 microgrammes/inhalation, poudre pou17901/0200 Symbicort 400/12 TurbohalerAT/H/0121/001 Belgium 240527 Cefadroxil Sandoz 500mg harde capsules 04416/0433 Cefadroxil 500mg capsNL/H/0343/002 Belgium 250223 Crestor 20mg filmomhulde tabletten 17901/0202 Crestor 20mg tabsSE/H/0304/001 Belgium 250381 Avodart 0.5mg capsules molles 19494/0006 Avodart 0.5mg soft capsDE/H/0384/001 Belgium 254852 Olmetec 10mg comprimés pelliculés 08265/0015 Olmetec 10mg tabsDE/H/0384/002 Belgium 254861 Olmetec 20mg comprimés pelliculés 08265/0016 Olmetec 20mg tabsDE/H/0384/003 Belgium 254877 Olmetec 40mg comprimés pelliculés 08265/0017 Olmetec 40mg tabsSE/H/0565/002 Belgium 258517 Co-Diovane 160 mg/12,5 mg comprimés pelliculés 00101/0650 Co-Diovan 160/12.5mg tabsFI/H/0313/001 Belgium 266384 Nebido 1000mg/4ml solution injectable 00010/0549 Nebido 1000mg/4ml injSE/H/0565/003 Belgium 271747 Co-Diovane 160 mg/25 mg comprimés pelliculés 00101/0651 Co-Diovan 160/25mg tabsNL/H/3915/001 Belgium 274181 Durogesic 12 microgrammes/heure, dispositif transdermique 00242/0409 Durogesic DTrans 12ug/hrFR/H/0272/001 Belgium 281653 Contramal Uno 100mg comprimés à libération prolongé 43808/0001 Tradorec XL 100mg tabsFR/H/0272/001 Belgium 281662 Contramal Uno 100mg comprimés à libération prolongé 43808/0001 Tradorec XL 100mg tabsFR/H/0272/001 Belgium 281671 Contramal Uno 100mg comprimés à libération prolongé 43808/0001 Tradorec XL 100mg tabsFR/H/0272/002 Belgium 281687 Contramal Uno 200mg comprimés à libération prolongé 43808/0002 Tradorec XL 200mg tabsFR/H/0272/002 Belgium 281696 Contramal Uno 200mg comprimés à libération prolongé 43808/0002 Tradorec XL 200mg tabsFR/H/0272/002 Belgium 281705 Contramal Uno 200mg comprimés à libération prolongé 43808/0002 Tradorec XL 200mg tabsFR/H/0272/003 Belgium 281714 Contramal Uno 300mg comprimés à libération prolongé 43808/0003 Tradorec XL 300mg tabsFR/H/0272/003 Belgium 281723 Contramal Uno 300mg comprimés à libération prolongé 43808/0003 Tradorec XL 300mg tabs

DE/H/0523/001 Belgium 282746 Olmetec Plus 20mg/12,5mg comprimés pelliculés 08265/0022 Olmetec Plus 20mg/12.5mg tabsDE/H/0523/002 Belgium 282764 Olmetec Plus 20mg/25mg comprimés pelliculés 08265/0023 Olmetec Plus 20mg/25mg tabsCZ/H/0939/001 Belgium 285196 Postinor 1500 ug comprime-tablet-tablette 04854/0150 Levonelle 1500mcg tabsSE/H/1876/001 Belgium 289177 Serevent 25 Microgrammes / dosis 10949/0369 Serevent 25 EvohalerDK/H/0134/002 Belgium 291663 Cosopt unit dose 20 mg/ml;5mg/ml 16058/0015 Cosopt SDUNL/H/0732/001 Belgium 293587 Mezavant 1200mg comprimé gastro-résistant à libération prolongée 08081/0040 Mezavant XL 1200mg tabsSE/H/0406/003 Belgium 296414 Diovane 80mg comprimes pellicules 00101/0600 Diovan 80mg tabsSE/H/0406/004 Belgium 296423 Diovane 160mg comprimes pellicules 00101/0601 Diovan 160mg tabsSE/H/0406/006 Belgium 297604 Diovane 320mg comprimes pellicules 00101/0726 Diovan 320mg tabsFR/H/0288/001 Belgium 302732 Geltim 1 mg/g, gel ophtalmique en récipient unidose 20162/0010 Tiopex 1mg/g eye gel SDUDE/H/5733/001 Belgium 312462 Versatis 700mg emplâtre médicamenteux 21727/0016 Versatis 700mg medicated plasterNL/H/0156/008 Belgium 314221 Seroquel XR 50mg comprimés à libération prolongée 50827/0006 Seroquel XL 50mg tabsNL/H/0156/009 Belgium 314246 Seroquel XR 200mg comprimés à libération prolongée 50827/0008 Seroquel XL 200mg tabsNL/H/0156/011 Belgium 314282 Seroquel XR 400mg comprimés à libération prolongée 50827/0010 Seroquel XL 400mg tabsNL/H/0156/010 Belgium 314564 Seroquel XR 300mg comprimés à libération prolongée 50827/0009 Seroquel XL 300mg tabsNL/H/0718/001 Belgium 316495 Spiriva Respimat 2,5 microgram, inhalatieoplossing 14598/0084 Spiriva RespimatNL/H/0156/012 Belgium 331974 Seroquel XR 150mg comprimés à libération prolongée 50827/0007 Seroquel XL 150mg tabsNL/H/1457/001 Belgium 341031 Cozaar 12.5mg comprimés pelliculés 00025/0515 Cozaar 12.5mg tabsNL/H/1457/002 Belgium 341047 Cozaar 50mg comprimés pelliculés 00025/0324 Cozaar 50mg tabsNL/H/1457/003 Belgium 341056 Cozaar 100mg comprimés pelliculés 00025/0416 Cozaar 100mg tabsNL/H/1458/001 Belgium 342754 Cozaar Plus 50mg/12,5mg comprimés pelliculés 00025/0338 Cozaar Comp 50mg/12.5mgNL/H/1458/003 Belgium 342763 Cozaar Plus Forte 100mg/25mg comprimés pelliculés 00025/0374 Cozaar Comp 100mg/25mgNL/H/1458/002 Belgium 342772 Cozaar Plus 100mg/12,5mg comprimés pelliculés 00025/0473 Cozaar Comp 100mg/12.5mgNL/H/1458/002 Belgium 342781 Cozaar Plus 100mg/12,5mg comprimés pelliculés 00025/0473 Cozaar Comp 100mg/12.5mg

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductDE/H/1913/001 Belgium 365285 Lercanidipine Teva 10mg comprimes pellicules 00289/1283 Lercanidipine hydrochloride 10mg tabsDE/H/1913/002 Belgium 365303 Lercanidipine Teva 20mg comprimes pellicules 00289/1284 Lercanidipine hydrochloride 20mg tabsDE/H/0523/003 Belgium 368645 Olmetec Plus 40mg/12,5mg comprimés pelliculés 08265/0029 Olmetec Plus 40mg/12.5mg tabsDE/H/0523/004 Belgium 368654 Olmetec Plus 40mg/25mg comprimés pelliculés 08265/0030 Olmetec Plus 40mg/25mg tabsDE/H/2251/001 Belgium 369774 Combodart 0,5mg/0,4mg gélules 19494/0046 Combodart 0.5mg/0.4mg capsDK/H/2871/001 Belgium 374211 Picoprep 03194/0014 PicolaxSE/H/0908/001 Belgium 382514 Jext 150 microgrammes solution injectable en stylo prerempli 10085/0052 Jext 150mcg PenSE/H/0908/002 Belgium 382523 Jext 300 microgrammes solution injectable en stylo prerempli 10085/0053 Jext 300mcg PenDE/H/2915/001 Belgium 409053 Latanoprost Pfizer 50 microgrammes/ml collyre en solution 00057/1221 Latanoprost Pfizer 50ug/ml eye dropsNL/H/3926/001 Belgium 415326 Affusine 20mg/g crème 20046/0256 Fusidic acid Focus 20mg/g creamDK/H/2888/001 Belgium 423586 Equasym XR 10mg gélules à libération modifiée 27303/0004 Equasym XL 10mg capsDK/H/2888/002 Belgium 423595 Equasym XR 20mg gélules à libération modifiée 27303/0005 Equasym XL 20mg capsDK/H/2888/003 Belgium 423604 Equasym XR 30mg gélules à libération modifiée 27303/0006 Equasym XL 30mg capsSE/H/1921/003 Belgium 429423 Flutiform 250mcg-10mcg 16950/0169 Flutiform 250mcg/10mcg inhalerDK/H/2028/001 Belgium 444936 Methylfenidaat Retard Sandoz 18mg comprimés à libération prolongée 04416/1346 Matoride XL 18mg tabsDK/H/2028/002 Belgium 444945 Methylfenidaat Retard Sandoz 36mg comprimés à libération prolongée 04416/1348 Matoride XL 36mg tabsDK/H/2028/003 Belgium 444954 Methylfenidaat Retard Sandoz 54mg comprimés à libération prolongée 04416/1349 Matoride XL 54mg tabsDK/H/0134/003 Belgium 530337 Cosopt Sine Conservans 16058/0025 Cosopt iMultiSE/H/0110/007 Belgium 1028 IS 90 F5 Topamax 15mg harde capsules 00242/0348 Topamax Sprinkle 15mg capsSE/H/0110/001 Belgium 2 BR 3 F3 Topamax 25mg tabletten 00242/0301 Topamax 25mg tabsSE/H/0110/007 Belgium 2 BR 4 F4 Topamax 15mg harde capsules 00242/0348 Topamax Sprinkle 15mg capsSE/H/0110/009 Belgium 2 BR 6 F4 Topamax 50mg harde capsules 00242/0350 Topamax Sprinkle 50mg capsSE/H/0110/003 Belgium 2 BR 8 F3 Topamax 100mg tabletten 00242/0303 Topamax 100mg tabsSE/H/0110/007 Belgium 2 IS 172 F5 Topamax 15mg harde capsules 00242/0348 Topamax Sprinkle 15mg capsNL/H/0487/001 Belgium 210 IS 167 F3 Vesicare 5mg 00166/0197 Vesicare 5mg tabsNL/H/0487/002 Belgium 210 IS 168 F3 Vesicare 10mg 00166/0198 Vesicare 10mg tabsDK/H/0012/005 Bulgaria 9700312 Genotropin 12mg (36 IU) 00057/0988 Genotropin 12mgSE/H/0229/001 Bulgaria 20010988 Symbicort Turbuhaler 160 micrograms/ 4,5 micrograms/ inhalation, inhalation powder 17901/0092 Symbicort 200/6 TurbohalerNL/H/1540/001 Bulgaria 20011209 Lamictal 25mg tablets 00003/0272 Lamictal 25mg tabsNL/H/1540/002 Bulgaria 20011210 Lamictal 50mg tablets 00003/0273 Lamictal 50mg tabsNL/H/1540/003 Bulgaria 20011211 Lamictal 100mg tablets 00003/0274 Lamictal 100mg tabsSE/H/0406/003 Bulgaria 20020027 Diovan 80mg film-coated tablets 00101/0600 Diovan 80mg tabsSE/H/0406/004 Bulgaria 20020028 Diovan 160mg film-coated tablets 00101/0601 Diovan 160mg tabsNL/H/0299/001 Bulgaria 20020374 Spiriva 18 microgram, inhalation powder, hard capsule 14598/0062 Spiriva 18mcg inhalation powderSE/H/0304/001 Bulgaria 20040103 Avodart 0.5mg soft capsules 19494/0006 Avodart 0.5mg soft capsSE/H/0406/005 Bulgaria 20050206 Diovan 40mg film-coated tablets 00101/0599 Diovan 40mg tabsSE/H/0229/002 Bulgaria 20060168 Symbicort Turbuhaler 320 micrograms/ 9 micrograms 17901/0200 Symbicort 400/12 TurbohalerDE/H/2251/001 Bulgaria 20100347 Duodart 0.5mg/0.4mg hard capsules 19494/0046 Combodart 0.5mg/0.4mg capsDK/H/2871/001 Bulgaria 20100450 Picoprep 03194/0014 PicolaxNL/H/0718/001 Bulgaria 20110382 Spiriva Respimat 2.5 microgram, inhalation solution 14598/0084 Spiriva RespimatDK/H/0134/003 Bulgaria Cosopt iMulti 16058/0025 Cosopt iMultiSE/H/1821/001 Croatia HR-H-032470068 Nasonex 50 mikrograma sprej za nos, suspenzija 00025/0587 Nasonex 50ug/actuation nasal sprayDE/H/4019/002 Croatia HR-H-141846183 Sandimmun Neoral 25mg meke kapsule 00101/0387 Neoral 25mg soft capsDE/H/4019/004 Croatia HR-H-144486729 Sandimmun Neoral 100mg meke kapsule 00101/0389 Neoral 100mg soft capsSE/H/0229/001 Croatia HR-H-203679076-06 Symbicort Turbuhaler 160 mikrograma/4,5 mikrograma po inhalaciji, prašak inhalata 17901/0092 Symbicort 200/6 TurbohalerNL/H/3915/002 Croatia HR-H-222344953 Durogesic 25 mikrograma/sat transdermalni flaster 00242/0192 Durogesic DTrans 25ug/hrNL/H/3915/003 Croatia HR-H-239768718 Durogesic 50 mikrograma/sat transdermalni flaster 00242/0193 Durogesic DTrans 50ug/hrSE/H/0169/003 Croatia HR-H-251056275-01-05 Seretide Diskus 50 mikrograma +500 mikrograma 10949/0316 Seretide 500 Accuhaler

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductNL/H/3915/001 Croatia HR-H-516334089 Durogesic 12 mikrograma/sat transdermalni flaster 00242/0409 Durogesic DTrans 12ug/hrDE/H/4019/003 Croatia HR-H-547220134 Sandimmun Neoral 50mg meke kapsule 00101/0388 Neoral 50mg soft capsSE/H/0169/002 Croatia HR-H-562619185-02 Seretide Diskus 50mcg-250mcg 10949/0315 Seretide 250 AccuhalerNL/H/3915/004 Croatia HR-H-613618293 Durogesic 75 mikrograma/sat transdermalni flaster 00242/0194 Durogesic DTrans 75ug/hrSE/H/0229/002 Croatia HR-H-680667236-01 Symbicort Turbuhaler 320 mikrograma/9 mikrograma po inhalaciji, prašak inhalata 17901/0200 Symbicort 400/12 TurbohalerNL/H/3915/005 Croatia HR-H-826093753 Durogesic 100 mikrograma/sat transdermalni flaster 00242/0195 Durogesic DTrans 100ug/hrDE/H/4019/005 Croatia HR-H-861000959 Sandimmun Neoral 100mg/ml oralna otopina 00101/0390 Neoral 100mg/ml solutionNL/H/0506/002 Croatia UP/I-530-09/06-01/223 Inspra 50mg tablete 50622/0029 Inspra 50mg tabsNL/H/0343/003 Croatia UP/I-530-09/06-01/407 Crestor 40mg filmom oblozene tablete 17901/0203 Crestor 40mg tabsNL/H/0487/001 Croatia UP/I-530-09/07-01/323 Vesicare 5mg filmom oblozene tablete 00166/0197 Vesicare 5mg tabsNL/H/0487/002 Croatia UP/I-530-09/07-01/324 Vesicare 10mg filmom oblozene tablete 00166/0198 Vesicare 10mg tabsSE/H/0230/001 Croatia UP/I-530-09/08-02/129 Symbicort Turbuhaler 80 mikrograma/4,5 mikrograma po inhalaciji, prašak inhalata 17901/0091 Symbicort 100/6 TurbohalerSE/H/0230/001 Croatia UP/I-530-09/08-02/130 Symbicort Turbuhaler 80 mikrograma/4,5 mikrograma po inhalaciji, prašak inhalata 17901/0091 Symbicort 100/6 TurbohalerSE/H/0229/001 Croatia UP/I-530-09/08-02/131 Symbicort Turbuhaler 160 mikrograma/4,5 mikrograma po inhalaciji, prašak inhalata 17901/0092 Symbicort 200/6 TurbohalerSE/H/0229/001 Croatia UP/I-530-09/08-02/132 Symbicort Turbuhaler 160 mikrograma/4,5 mikrograma po inhalaciji, prašak inhalata 17901/0092 Symbicort 200/6 TurbohalerSE/H/0229/002 Croatia UP/I-530-09/08-02/133 Symbicort Turbuhaler 320 mikrograma/9 mikrograma po inhalaciji, prašak inhalata 17901/0200 Symbicort 400/12 TurbohalerIE/H/0165/001 Croatia UP/I-530-09/09-02/528 Prograf 0,5 mg tvrde kapsule 00166/0206 Prograf 0.5mg hard capsIE/H/0165/002 Croatia UP/I-530-09/09-02/529 Prograf 1 mg tvrde kapsule 00166/0203 Prograf 1mg hard capsIE/H/0165/003 Croatia UP/I-530-09/09-02/530 Prograf 5 mg tvrde kapsule 00166/0204 Prograf 5mg hard capsFR/H/0181/006 Croatia UP/I-530-09/10-01/200 Glucophage 1000mg prasak za oralnu otopinu u vrecicama 11648/0090 Glucophage 1000mg powder for solutionSE/H/0304/001 Croatia UP/I-530-09/10-02/15 Avodart 0.5mg meke kapsule 19494/0006 Avodart 0.5mg soft capsSE/H/1876/001 Croatia UP/I-530-09/10-02/196 Serevent Inhaler 25 mikrograma/dozi, stlaceni inhalat, suspenzija 10949/0369 Serevent 25 EvohalerNL/H/0380/001 Croatia UP/I-530-09/10-02/230 Angeliq 1mg/2mg Filmom Oblozene Tablete 00010/0518 Angeliq tabsNL/H/0343/003 Croatia UP/I-530-09/10-02/436 Crestor 40mg filmom oblozene tablete 17901/0203 Crestor 40mg tabsNL/H/0343/002 Croatia UP/I-530-09/10-02/437 Crestor 20mg filmom oblozene tablete 17901/0202 Crestor 20mg tabsNL/H/0343/001 Croatia UP/I-530-09/10-02/438 Crestor 10mg filmom oblozene tablete 17901/0201 Crestor 10mg tabsNL/H/0506/001 Croatia UP/I-530-09/11-02/231 Inspra 25mg filmom oblozene tablete 50622/0028 Inspra 25mg tabsNL/H/0506/002 Croatia UP/I-530-09/11-02/232 Inspra 50mg filmom oblozene tablete 50622/0029 Inspra 50mg tabsSE/H/0169/001 Croatia UP/I-530-09/11-02/350 Seretide Diskus 50 mikrograma +100 mikrograma u jednoj dozi, prasak, inhalata, dozir 10949/0314 Seretide 100 AccuhalerSE/H/0169/002 Croatia UP/I-530-09/11-02/351 Seretide Diskus 50mcg-250mcg 10949/0315 Seretide 250 AccuhalerSE/H/0169/003 Croatia UP/I-530-09/11-02/352 Seretide Diskus 50 mikrograma +500 mikrograma 10949/0316 Seretide 500 AccuhalerSE/H/0147/001 Croatia UP/I-530-09/14-01/168 Cerazette 75 mikrograma filmom obložene tablete 00025/0562 Cerazette 75mcg tabsDE/H/5733/001 Czech Republic 01/284/10-C Versatis 700mg léčivá náplast 21727/0016 Versatis 700mg medicated plasterDE/H/6007/001 Czech Republic 06/407/08-C Concerta 18mg tablety s predlzenym uvolnovanim 00242/0372 Concerta XL 18mg tabsDE/H/6007/002 Czech Republic 06/408/08-C Concerta 36mg tablety s predlzenym uvolnovanim 00242/0373 Concerta XL 36mg tabsSE/H/1861/002 Czech Republic 14/003/05-C Alvesco 160 inhaler 17901/0298 Alvesco 160 inhalerNL/H/0150/001 Czech Republic 14/049/01-C Nexplanon 68 mg subkutánní implantát 00025/0563 NexplanonSE/H/0169/001 Czech Republic 14/101/00-C Seretide Diskus 50 mikrogramů/100 mikrogramů 10949/0314 Seretide 100 AccuhalerSE/H/0169/002 Czech Republic 14/102/00-C Seretide Diskus 50 mikrogramů/250 mikrogramů 10949/0315 Seretide 250 AccuhalerSE/H/0169/003 Czech Republic 14/103/00-C Seretide Diskus 50 mikrogramů/500 mikrogramů 10949/0316 Seretide 500 AccuhalerNL/H/0299/001 Czech Republic 14/174/02-C Spiriva prasek k inhalaci v tvrdych tobolkach 14598/0062 Spiriva 18mcg inhalation powderDE/H/0528/001 Czech Republic 14/216/05-C Atimos 12 mikrogramow/dawke odmierzona aerozol inhalacyjny roztwor 08829/0154 Atimos ModuliteSE/H/0230/001 Czech Republic 14/231/01-C Symbicort Turbuhaler 100 mikrogramu / 6 mikrogramu / inhalace 17901/0091 Symbicort 100/6 TurbohalerSE/H/0229/001 Czech Republic 14/232/01-C Symbicort Turbuhaler 200 mikrogramu / 6 mikrogramu / inhalace 17901/0092 Symbicort 200/6 TurbohalerSE/H/0229/002 Czech Republic 14/289/02-C Symbicort 400/12 Turbuhaler 17901/0200 Symbicort 400/12 TurbohalerDE/H/0871/001 Czech Republic 14/302/07-C Combair 100/6 mikrogramů v jednotlivé dávce, roztok k inhalaci v tlakovém obalu 08829/0156 Fostair 100/6 inhalerES/H/0653/001 Czech Republic 14/314/16-C Braltus 10 mikrogramu/davka prasek k inhalaci v tvrde tobolce 00289/1870 Braltus 10mcg inhalation powderSE/H/1921/001 Czech Republic 14/553/12-C Flutiform 50 mikrogramu/ 5 mikrogramu v jedne davce suspenze k inhalaci v tlakovem 16950/0167 Flutiform 50mcg/5mcg inhaler

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductSE/H/1921/002 Czech Republic 14/554/12-C Flutiform 125 mikrogramu/5 mikrogramu v jedne davce suspenze k inhalaci v tlakovem 16950/0168 Flutiform 125mcg/5mcg inhalerSE/H/1921/003 Czech Republic 14/555/12-C Flutiform 250 mikrogramu/ 10 mikrogramu v jedne davce suspenze k inalaci v tlakovem16950/0169 Flutiform 250mcg/10mcg inhalerNL/H/0718/001 Czech Republic 14/666/07-C Spiriva Respimat 2,5 mikrogramu, roztok k inhalaci 14598/0084 Spiriva RespimatDE/H/5724/001 Czech Republic 14/679/16-C Serkep 25mcg/125mcg/dav 04569/1449 Sirdupla 25/125mcg inhalerDE/H/5724/002 Czech Republic 14/680/16-C Serkep 25mcg/250mcg/dav 04569/1450 Sirdupla 25/250mcg inhalerSE/H/1921/005 Czech Republic 14/809/15-C Flutiform K-Haler 125mcg/5mcg/dav 16950/0339 Flutiform K-Haler 125mcg/5mcgPT/H/2363/001 Czech Republic 15/265/00-C Augmentin Duo, prášek pro perorální suspenzi 10592/0070 Augmentin Duo 400/57SE/H/1984/001 Czech Republic 15/370/11-C Oracea 40 mg tvrdé tobolky s řízeným uvolňováním 10590/0056 Efracea 40mg capsAT/H/0754/001 Czech Republic 16/338/01-A/C Clexane Forte 12000IU/0.8ml 04425/0185 Clexane Forte 12000IU (120mg)/0.8mlAT/H/0754/002 Czech Republic 16/338/01-B/C Clexane Forte 15000IU/1ml 04425/0185 Clexane Forte 15000IU (150mg)/1mlNL/H/1539/002 Czech Republic 21/483/96-A/C Lamictal 5 mg, žvýkací/dispergovatelné tablety 00003/0346 Lamictal 5mg dispersible tabsNL/H/1539/003 Czech Republic 21/483/96-B/C Lamictal 25 mg, žvýkací/dispergovatelné tablety 00003/0347 Lamictal 25mg dispersible tabsNL/H/1539/005 Czech Republic 21/483/96-C/C Lamictal 100 mg, žvýkací/dispergovatelné tablety 00003/0348 Lamictal 100mg dispersible tabsSE/H/0110/003 Czech Republic 21/512/97-C Topamax 100mg 00242/0303 Topamax 100mg tabsNL/H/1540/001 Czech Republic 21/802/92-A/C Lamictal 25 mg 00003/0272 Lamictal 25mg tabsNL/H/1540/002 Czech Republic 21/802/92-B/C Lamictal 50 mg 00003/0273 Lamictal 50mg tabsNL/H/1540/003 Czech Republic 21/802/92-C/C Lamictal 100 mg 00003/0274 Lamictal 100mg tabsDE/H/0299/001 Czech Republic 24/050/02-C Xyzal 5mg, potahované tablety 00039/0539 Xyzal 5mg tabsDE/H/6220/001 Czech Republic 25/547/05-C Malarone, potahované tablety 250mg/100 mg 10949/0258 Malarone tabsSE/H/0643/001 Czech Republic 29/689/08-C Metoject 50 mg/ml injekcni roztok 11587/0046 Metoject 50mg/ml soln for injSE/H/0278/002 Czech Republic 30/276/02-C Cipralex 10mg potahovane tablety 13761/0009 Cipralex 10mg tabsNL/H/0566/002 Czech Republic 30/490/96-B/C Seroxat 30mg 10592/0002 Seroxat 30mg tabsSE/H/0278/006 Czech Republic 30/494/07-C Cipralex 20 mg/ ml peroralni kapky, roztok 13761/0028 Cipralex 20mg/ml solnSE/H/0936/002 Czech Republic 30/686/99-C Efectin ER 75mg tvrde tobolky s prodlouzenym uvolnovanim 50622/0020 Efexor XL 75mg capsSE/H/0936/003 Czech Republic 30/687/99-C Efectin ER 150mg tvrde tobolky s prodlouzenym uvolnovanim 00057/1281 Efexor XL 150mg capsDE/H/0116/003 Czech Republic 31/127/01-C Lescol XL 80mg 00101/0587 Lescol XL 80mg tabsDE/H/0109/001 Czech Republic 31/233/99-C Sortis 10mg 50622/0036 Lipitor 10mg tabsDE/H/0109/003 Czech Republic 31/235/99-C Sortis 40mg 50622/0041 Lipitor 40mg tabsDE/H/0396/001 Czech Republic 31/267/03-C Ezetrol 10mg tablety 00025/0609 Ezetrol 10mg tabsDE/H/0109/004 Czech Republic 31/397/03-C Sortis 80mg 50622/0043 Lipitor 80mg tabsNL/H/0506/002 Czech Republic 34/012/06-C Inspra 50mg potahované tablety 50622/0029 Inspra 50mg tabsAT/H/0904/001 Czech Republic 44/1296/97-C Arimidex por tbl flm 17901/0002 Arimidex 1mg tabsFR/H/0110/001 Czech Republic 44/283/99-C Femara 2,5 mg potahované tablety 00101/0493 Femara 2.5mg tabsDK/H/2478/001 Czech Republic 46/254/16-C Enstilar 50 mikrogramů/g +0,5 mg/g kožní pěna 05293/0008 Enstilar 50mcg/g+0.5mg/g foamDK/H/0279/002 Czech Republic 46/845/11-C Daivobet gel 50 mikrogramu-g plus 0,5 mg-g gel 05293/0005 Dovobet gelFI/H/0313/001 Czech Republic 56/0176/05-C Nebido 1000mg/4ml injekční roztok 00010/0549 Nebido 1000mg/4ml injDK/H/0001/005 Czech Republic 56/221/01-C Norditropin SimpleXx 5mg/1,5ml 03132/0131 Norditropin SimpleXx 5mg/1.5ml cartridgeDK/H/0001/006 Czech Republic 56/222/01-C Norditropin SimpleXx 10mg/1,5ml 03132/0132 Norditropin SimpleXx 10mg/1.5ml cartridgeDK/H/0001/007 Czech Republic 56/223/01-C Norditropin SimpleXx 15mg/1,5ml 03132/0133 Norditropin SimpleXx 15mg/1.5ml cartridgeHU/H/0399/001 Czech Republic 56/349/16-C Dexamethasone Krka 4mg tablety 01656/0205 Dexamethasone 4mg tabsNL/H/2280/002 Czech Republic 56/434/10-C Femoston mini 0,5 mg/2,5 mg, potahovane tablety 46302/0037 Femoston-Conti 0.5mg/2.5mg tabsFR/H/0265/002 Czech Republic 58/162/05-C Prestarium Neo 05815/0036 Coversyl Arginine 5mg tabsFR/H/0265/003 Czech Republic 58/163/05-C Prestarium Neo Forte 05815/0037 Coversyl Arginine 10mg tabsSE/H/0406/005 Czech Republic 58/176/03-C Diovan 40mg 00101/0599 Diovan 40mg tabsSE/H/0406/004 Czech Republic 58/282/01-C Diovan 160mg 00101/0601 Diovan 160mg tabsNL/H/1457/002 Czech Republic 58/607/08-C Cozaar 50mg potahované tablety 00025/0324 Cozaar 50mg tabsNL/H/1457/003 Czech Republic 58/608/08-C Cozaar 100mg potahované tablety 00025/0416 Cozaar 100mg tabsDE/H/4019/002 Czech Republic 59/649/95-A/C Sandimmun Neoral 25mg měkké tobolky 00101/0387 Neoral 25mg soft caps

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductDE/H/4019/003 Czech Republic 59/649/95-B/C Sandimmun Neoral 50mg měkké tobolky 00101/0388 Neoral 50mg soft capsDE/H/4019/004 Czech Republic 59/649/95-C/C Sandimmun Neoral 100mg měkké tobolky 00101/0389 Neoral 100mg soft capsDE/H/4019/005 Czech Republic 59/665/95-C Sandimmun Neoral 100mg/ml perorální roztok 00101/0390 Neoral 100mg/ml solutionIE/H/0165/002 Czech Republic 59/758/99-C Prograf 1mg tvrde tobolky 00166/0203 Prograf 1mg hard capsDK/H/2871/001 Czech Republic 61/497/10-C Picoprep 03194/0014 PicolaxSE/H/0225/001 Czech Republic 64/045/01-C Zaditen 0,025% 20162/0019 Zaditen 0.25mg/ml eye dropsDK/H/0134/003 Czech Republic 64/118/17-C Cosopt bez konzervačních přísad 20mg/ml + 5mg/ml oční kapky, roztok 16058/0025 Cosopt iMultiFI/H/0989/0001 Czech Republic 64/175/05-C Oftaquix 5mg/ml ocni kapky 16058/0006 Oftaquix 5mg/ml eye dropsDK/H/0134/002 Czech Republic 64/265/06-C Cosopt FREE bez konzervacnich prisad 20mg/ml 5 mg/m 16058/0015 Cosopt SDUDE/H/0991/002 Czech Republic 64/314/08-C Taflotan 15 mikrogramu/ml ocni kapky, roztok, jedn 16058/0017 Saflutan 15ug/ml eye dropsDK/H/3023/001 Czech Republic 64/486/05-C Combigan 2mg/ml + 5mg/ml ocni kapky, roztok 41443/0006 Combigan eye dropsDE/H/2020/004 Czech Republic 65/015/11-C Palexia retard 50mg tablety s prodlouženým uvolňováním 21727/0041 Palexia SR 50mg tabsDE/H/2020/005 Czech Republic 65/016/11-C Palexia retard 100mg tablety s prodlouženým uvolňováním 21727/0042 Palexia SR 100mg tabsDE/H/2020/006 Czech Republic 65/017/11-C Palexia retard 150mg tablety s prodlouženým uvolňováním 21727/0043 Palexia SR 150mg tabsDE/H/2020/007 Czech Republic 65/018/11-C Palexia retard 200mg tablety s prodlouženým uvolňováním 21727/0044 Palexia SR 200mg tabsDE/H/2020/008 Czech Republic 65/019/11-C Palexia retard 250mg tablety s prodlouženým uvolňováním 21727/0045 Palexia SR 250mg tabsNL/H/3915/001 Czech Republic 65/059/06-C Durogesic 12 mikrogramů/hodinu transdermální náplast 00242/0409 Durogesic DTrans 12ug/hrDE/H/2020/009 Czech Republic 65/310/12-C Palexia retard 25mg tablety s prodlouženým uvolňováním 21727/0051 Palexia SR 25mg tabsFR/H/0272/001 Czech republic 65/490/05-C Noax Uno 100mg tablety s prodlouženým uvolňováním 43808/0001 Tradorec XL 100mg tabsFR/H/0272/002 Czech republic 65/491/05-C Noax Uno 200mg tablety s prodlouženým uvolňováním 43808/0002 Tradorec XL 200mg tabsFR/H/0272/003 Czech republic 65/492/05-C Noax Uno 300mg tablety s prodlouženým uvolňováním 43808/0003 Tradorec XL 300mg tabs

NL/H/3915/002 Czech Republic 65/716/97-C Durogesic 25 mikrogramů/hodinu transdermální náplast 00242/0192 Durogesic DTrans 25ug/hrNL/H/3915/003 Czech Republic 65/717/97-C Durogesic 50 mikrogramů/hodinu transdermální náplast 00242/0193 Durogesic DTrans 50ug/hrNL/H/3915/004 Czech Republic 65/718/97-C Durogesic 75 mikrogramů/hodinu transdermální náplast 00242/0194 Durogesic DTrans 75ug/hrNL/H/3915/005 Czech Republic 65/719/97-C Durogesic 100 mikrogramů/hodinu transdermální náplast 00242/0195 Durogesic DTrans 100ug/hrSE/H/1821/001 Czech Republic 69/088/99-C Nasonex Nosni sprej, suspenze 00025/0587 Nasonex 50ug/actuation nasal sprayDE/H/3355/001 Czech Republic 69/338/13-C Dymistin 137 mikrogramů/50 mikrogramů, nosní sprej, suspenze 15142/0258 Dymista Nasal SprayNL/H/0487/001 Czech Republic 73/066/05-C Vesicare 5mg 00166/0197 Vesicare 5mg tabsNL/H/0487/002 Czech Republic 73/067/05-C Vesicare 10mg 00166/0198 Vesicare 10mg tabsNL/H/2968/001 Czech Republic 73/439/13-C Urizia 6mg/0.4mg tablety Rizenym Uvolnovanim 00166/0404 Vesomni 6mg/0.4mg tabsSE/H/1505/003 Czech Republic 83/115/92-C/C Plendil ER 10mg 17901/0155 Plendil 10mg tabsSE/H/0481/002 Czech Republic 87/104/05-C Fosrenol 500 mg žvýkací tablety 08081/0042 Fosrenol 500mg tabsSE/H/0481/004 Czech Republic 87/106/05-C Fosrenol 1000mg žvýkací tablety 08081/0044 Fosrenol 1000mg tabsSE/H/0481/004 Czech Republic 87/106/05-C Fosrenol 1000mg Zvykaci Tablety 08081/0044 Fosrenol 1000mg tabsSE/H/0304/001 Czech Republic 87/287/03-C Avodart 0.5mg mekke tobolky 19494/0006 Avodart 0.5mg soft capsDE/H/2251/001 Czech Republic 87/349/10-C Duodart 0,5mg/0,4mg, tvrdé tobolky 19494/0046 Combodart 0.5mg/0.4mg capsNL/H/3915/002 Denmark 15451 Durogesic 25 mikrogram/time depotplaster 00242/0192 Durogesic DTrans 25ug/hrNL/H/3915/003 Denmark 15452 Durogesic 50 mikrogram/time depotplaster 00242/0193 Durogesic DTrans 50ug/hrNL/H/3915/004 Denmark 15453 Durogesic 75 mikrogram/time depotplaster 00242/0194 Durogesic DTrans 75ug/hrNL/H/3915/005 Denmark 15454 Durogesic 100 mikrogram/time depotplaster 00242/0195 Durogesic DTrans 100ug/hrDE/H/4019/002 Denmark 15804 Sandimmun Neoral 25mg bløde kapsler 00101/0387 Neoral 25mg soft capsDE/H/4019/003 Denmark 15805 Sandimmun Neoral 50mg bløde kapsler 00101/0388 Neoral 50mg soft capsDE/H/4019/004 Denmark 15806 Sandimmun Neoral 100mg bløde kapsler 00101/0389 Neoral 100mg soft capsDE/H/4019/005 Denmark 15807 Sandimmun Neoral 100mg/ml oral opløsning 00101/0390 Neoral 100mg/ml solutionNL/H/1457/002 Denmark 15844 Cozaar 50mg filmovertrukne tabletter 00025/0324 Cozaar 50mg tabsNL/H/1458/001 Denmark 17535 Cozaar Comp Forte 50mg/12.5mg filmovertrukne tabletter 00025/0338 Cozaar Comp 50mg/12.5mgNL/H/4790/001 Denmark 18427 Zanidip 10mg filmovertrukne tabletter 04595/0005 Zanidip 10mg tabsDE/H/4019/001 Denmark 18671 Sandimmun Neoral 10mg bløde kapsler 00101/0483 Neoral 10mg soft caps

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductDE/H/6157/001 Denmark 18752 Xalatan, øjendråber, opløsning 00057/1057 Xalatan eye dropsSE/H/1821/001 Denmark 18877 Nasonex, næsespray, suspension 00025/0587 Nasonex 50ug/actuation nasal sprayNL/H/1457/001 Denmark 18978 Cozaar 12.5mg filmovertrukne tabletter 00025/0515 Cozaar 12.5mg tabsSE/H/0565/001 Denmark 19338 Diovan Comp 80 mg/12,5 mg, filmovertrukne tabletter 00101/0480 Co-Diovan 80/12.5mg tabsSE/H/0147/001 Denmark 30070 Cerazette 75 mikrogram filmovertrukne tabletter 00025/0562 Cerazette 75mcg tabsNL/H/0150/001 Denmark 30379 Implanon NXT 00025/0563 NexplanonSE/H/0169/001 Denmark 30386 Seretide 50 mikrogram/100 mikrogram/dosis 10949/0314 Seretide 100 AccuhalerSE/H/0169/002 Denmark 30387 Seretide 50 mikrogram/250 mikrogram/dosis 10949/0315 Seretide 250 AccuhalerSE/H/0169/002 Denmark 30387 Seretide inhalationspulver i Diskos 50 mikrogram/250 mikrogram/dosis 10949/0315 Seretide 250 AccuhalerSE/H/0169/003 Denmark 30388 Seretide 50 mikrogram/500 mikrogram/dosis 10949/0316 Seretide 500 AccuhalerSE/H/0229/001 Denmark 31410 Symbicort Turbuhaler, inhalationspulver 17901/0092 Symbicort 200/6 TurbohalerSE/H/1843/001 Denmark 31466 Zidoval 7,5mg/g Gel Vaginal 46302/0153 Zidoval 7.5mg/g Vaginal gelSE/H/0230/001 Denmark 31796 Symbicort Mite Turbuhaler, inhalationspulver 17901/0091 Symbicort 100/6 TurbohalerDE/H/5770/002 Denmark 31804 Seretide 25 mikrogram/125 mikrogram/dosis inhalationsspray, suspension 10949/0338 Seretide 125 EvohalerDE/H/5770/003 Denmark 31805 Seretide 25 mikrogram/250 mikrogram/dosis inhalationsspray, suspension 10949/0339 Seretide 250 EvohalerDE/H/5646/001 Denmark 32220 Caverject Dual 10 mikrogram/0.5ml Pulver og solvens til injektionsvæske, opløsning 00057/0939 Caverject DCS 10ugDE/H/5646/002 Denmark 32221 Caverject Dual 20 mikrogram/0.5ml Pulver og solvens til injektionsvæske, opløsning 00057/0940 Caverject DCS 20ugSE/H/0249/001 Denmark 32311 Xalcom, øjendråber, opløsning 00057/1056 Xalacom eye dropsNL/H/0156/001 Denmark 32334 Seroquel 25mg filmovertrukne tabletter 50827/0002 Seroquel 25mg tabsNL/H/0156/002 Denmark 32335 Seroquel 100mg filmovertrukne tabletter 50827/0003 Seroquel 100mg tabsNL/H/0156/003 Denmark 32336 Seroquel 200mg filmovertrukne tabletter 50827/0004 Seroquel 200mg tabsNL/H/0156/007 Denmark 32600 Seroquel 300mg filmovertrukne tabletter 50827/0005 Seroquel 300mg tabsDE/H/0299/001 Denmark 32719 Xyzal 5mg filmovertrukne tabletter 00039/0539 Xyzal 5mg tabsSE/H/0406/003 Denmark 32751 Diovan filmovertrukne tabletter 80mg 00101/0600 Diovan 80mg tabsSE/H/0406/004 Denmark 32752 Diovan filmovertrukne tabletter 160mg 00101/0601 Diovan 160mg tabsNL/H/1457/003 Denmark 32842 Cozaar 100mg filmovertrukne tabletter 00025/0416 Cozaar 100mg tabsNL/H/1458/003 Denmark 32905 Cozaar Comp Forte 100mg/25mg filmovertrukne tabletter 00025/0374 Cozaar Comp 100mg/25mgNL/H/0299/001 Denmark 33279 Spiriva, inhalationspulver, hård kapsel 18 mikrogram 14598/0062 Spiriva 18mcg inhalation powderSE/H/0229/002 Denmark 33490 Symbicort Forte Turbuhaler, inhalationspulver 17901/0200 Symbicort 400/12 TurbohalerDE/H/0307/001 Denmark 34083 Transtec 35 mikrogram/t depotplaster 04539/0014 Transtec 35ug/hr patchDE/H/0307/002 Denmark 34084 Transtec 52.5 mikrogram/t depotplaster 04539/0015 Transtec 52.5ug/hr patchDE/H/0307/003 Denmark 34085 Transtec 70 mikrogram/t depotplaster 04539/0016 Transtec 70ug/hr patchDE/H/0384/001 Denmark 34529 Olmetec 10mg filmovertrukne tabletter 08265/0015 Olmetec 10mg tabsDE/H/0384/002 Denmark 34530 Olmetec 20mg filmovertrukne tabletter 08265/0016 Olmetec 20mg tabsDE/H/0384/003 Denmark 34531 Olmetec 40mg filmovertrukne tabletter 08265/0017 Olmetec 40mg tabsFR/H/0228/001 Denmark 34657 Duraphat 5mg/g tandpasta 00049/0050 Duraphat 5000ppm fluoride toothpasteNL/H/4790/002 Denmark 34882 Zanidip 20mg filmovertrukne tabletter 04595/0010 Zanidip 20mg tabsSE/H/0565/002 Denmark 35127 Diovan Comp 160 mg/12,5 mg, filmovertrukne tabletter 00101/0650 Co-Diovan 160/12.5mg tabsFI/H/0313/001 Denmark 36481 Nebido 1000mg/4ml injektionsvæske opløsning 00010/0549 Nebido 1000mg/4ml injSE/H/0565/003 Denmark 36787 Diovan Comp 160 mg/25 mg, filmovertrukne tabletter 00101/0651 Co-Diovan 160/25mg tabsNL/H/3915/001 Denmark 37604 Durogesic 12 mikrogram/time depotplaster 00242/0409 Durogesic DTrans 12ug/hrSE/H/0406/005 Denmark 37642 Diovan filmovertrukne tabletter 40mg 00101/0599 Diovan 40mg tabsFI/H/0981/001 Denmark 37948 Tobradex, øjendråber, suspension 00101/1007 Tobradex eye dropsDE/H/0523/001 Denmark 38146 Olmetec Plus 20mg/12,5mg filmovertrukne tabletter 08265/0022 Olmetec Plus 20mg/12.5mg tabsDE/H/0523/002 Denmark 38147 Olmetec Plus 20mg/25mg filmovertrukne tabletter 08265/0023 Olmetec Plus 20mg/25mg tabsDK/H/2888/001 Denmark 38534 Equasym Depot 10mg hårde kapsler med modificeret udløsning 27303/0004 Equasym XL 10mg capsDK/H/2888/002 Denmark 38535 Equasym Depot 20mg hårde kapsler med modificeret udløsning 27303/0005 Equasym XL 20mg capsDK/H/2888/003 Denmark 38536 Equasym Depot 30mg hårde kapsler med modificeret udløsning 27303/0006 Equasym XL 30mg caps

Version: 11/11/2020 Page: 10 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductNL/H/1458/002 Denmark 38633 Cozaar Comp Forte 100mg/12.5mg filmovertrukne tabletter 00025/0473 Cozaar Comp 100mg/12.5mgNL/H/0732/001 Denmark 38969 Mezavant 1200mg enterodepottabletter 08081/0040 Mezavant XL 1200mg tabsDE/H/0690/001 Denmark 39397 Medikinet 5mg tabletter 11243/0002 Medikinet 5mg tabsDE/H/0690/002 Denmark 39398 Medikinet 10mg tabletter 11243/0003 Medikinet 10mg tabsDE/H/0690/003 Denmark 39399 Medikinet 20mg tabletter 11243/0004 Medikinet 20mg tabsDE/H/0690/004 Denmark 39458 Medikinet CR, hårde kapsler med modificeret udløsning 10 mg 11243/0005 Medikinet XL 10mg capsDE/H/0690/005 Denmark 39459 Medikinet CR, hårde kapsler med modificeret udløsning 20 mg 11243/0006 Medikinet XL 20mg capsDE/H/0690/006 Denmark 39460 Medikinet CR, hårde kapsler med modificeret udløsning 30 mg 11243/0007 Medikinet XL 30mg capsDE/H/0690/007 Denmark 39461 Medikinet CR, hårde kapsler med modificeret udløsning 40 mg 11243/0008 Medikinet XL 40mg capsNL/H/0718/001 Denmark 39853 Spiriva Respimat, inhalationsvæske, opløsning 14598/0084 Spiriva RespimatSE/H/0406/006 Denmark 39956 Diovan filmovertrukne tabletter 320mg 00101/0726 Diovan 320mg tabsNL/H/0156/008 Denmark 42031 Seroquel prolong 50mg depottabletter 50827/0006 Seroquel XL 50mg tabsNL/H/0156/009 Denmark 42032 Seroquel prolong 200mg depottabletter 50827/0008 Seroquel XL 200mg tabsNL/H/0156/010 Denmark 42033 Seroquel prolong 300mg depottabletter 50827/0009 Seroquel XL 300mg tabsNL/H/0156/011 Denmark 42034 Seroquel prolong 400mg depottabletter 50827/0010 Seroquel XL 400mg tabsNL/H/0156/012 Denmark 43173 Seroquel prolong 150mg depottabletter 50827/0007 Seroquel XL 150mg tabsDE/H/2251/001 Denmark 44502 Combodart 0,5mg/0,4mg hårde kapsler 19494/0046 Combodart 0.5mg/0.4mg capsDE/H/0523/003 Denmark 44538 Olmetec Plus 40mg/12,5mg filmovertrukne tabletter 08265/0029 Olmetec Plus 40mg/12.5mg tabsDE/H/0523/004 Denmark 44539 Olmetec Plus 40mg/25mg filmovertrukne tabletter 08265/0030 Olmetec Plus 40mg/25mg tabsDE/H/2020/004 Denmark 45154 Palexia depot 50mg depottabletter 21727/0041 Palexia SR 50mg tabsDE/H/2020/005 Denmark 45155 Palexia depot 100mg depottabletter 21727/0042 Palexia SR 100mg tabsDE/H/2020/006 Denmark 45156 Palexia depot 150mg depottabletter 21727/0043 Palexia SR 150mg tabsDE/H/2020/007 Denmark 45157 Palexia depot 200mg depottabletter 21727/0044 Palexia SR 200mg tabsDE/H/2020/008 Denmark 45158 Palexia depot 250mg depottabletter 21727/0045 Palexia SR 250mg tabsSE/H/0908/001 Denmark 45929 Jext 150 mikrogram Injektionsvæske, opløsning i fyldt pen 10085/0052 Jext 150mcg PenSE/H/0908/002 Denmark 45930 Jext 300 mikrogram Injektionsvæske, opløsning i fyldt pen 10085/0053 Jext 300mcg PenDK/H/2871/001 Denmark 46212 Picoprep 03194/0014 PicolaxDE/H/5733/001 Denmark 46834 Versatis 700mg medicinsk plaster 21727/0016 Versatis 700mg medicated plasterSE/H/1984/001 Denmark 46849 Oracea, hårde kapsler med modificeret udløsning 10590/0056 Efracea 40mg capsDE/H/2915/001 Denmark 47218 Latanoprost Pfizer, øjendråber, opløsning 50 mikrogram-ml 00057/1221 Latanoprost Pfizer 50ug/ml eye dropsDE/H/0690/008 Denmark 47393 Medikinet CR, hårde kapsler med modificeret udløsning 5 mg 11243/0010 Medikinet XL 5mg capsDK/H/2028/001 Denmark 48096 Methylphenidate Sandoz depottabletter 18mg 04416/1346 Matoride XL 18mg tabsDK/H/2028/002 Denmark 48097 Methylphenidate Sandoz depottabletter 36mg 04416/1348 Matoride XL 36mg tabsDK/H/2028/003 Denmark 48098 Methylphenidate Sandoz depottabletter 54mg 04416/1349 Matoride XL 54mg tabsSE/H/1074/001 Denmark 48608 Latanoprost-Timolol Pfizer, øjendråber, opløsning 50 mikrog-ml+5 mg-ml 00057/1322 Latanoprost/Timolol Pfizer 50+5 ug/mlDE/H/2020/009 Denmark 48784 Palexia depot 25mg depottabletter 21727/0051 Palexia SR 25mg tabsDE/H/3355/001 Denmark 49785 Dymista 137 mikrogram/50 mikrogram pr. Dosis Næsespray, suspension 15142/0258 Dymista Nasal SprayDK/H/2888/004 Denmark 50037 Equasym Depot 40mg hårde kapsler med modificeret udløsning 27303/0007 Equasym XL 40mg capsDK/H/2888/005 Denmark 50038 Equasym Depot 50mg hårde kapsler med modificeret udløsning 27303/0008 Equasym XL 50mg capsDK/H/2888/006 Denmark 50039 Equasym Depot 60mg hårde kapsler med modificeret udløsning 27303/0009 Equasym XL 60mg capsFI/H/0822/001 Denmark 52357 Hydrokortison Orion tablets 10mg 30322/0015 Hydrocortisone Alissa 10mg tabsDK/H/0134/003 Denmark 59349 Cosopt iMulti Ukonserveret, øjendråber, opløsning 16058/0025 Cosopt iMultiSE/H/1821/001 Estonia 191898 Nasonex, 50 mikrogrammi/pihustus ninasprei, suspensioon 00025/0587 Nasonex 50ug/actuation nasal sprayPT/H/2363/001 Estonia 213498 Augmentin, 400 mg/57 mg/5 ml suukaudse suspensiooni pulber 10592/0070 Augmentin Duo 400/57SE/H/0565/001 Estonia 246499 Co-Diovan, 80/12,5 mg õhukese polümeerikattega tabletid 00101/0480 Co-Diovan 80/12.5mg tabsNL/H/0156/003 Estonia 257099 Seroquel 200mg õhukese polümeerikattega tabletid 50827/0004 Seroquel 200mg tabsNL/H/0156/002 Estonia 257199 Seroquel 100mg õhukese polümeerikattega tabletid 50827/0003 Seroquel 100mg tabsSE/H/0169/002 Estonia 272499 Seretide Diskus 250 10949/0315 Seretide 250 Accuhaler

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductSE/H/0169/001 Estonia 272599 Seretide Diskus 100 10949/0314 Seretide 100 AccuhalerSE/H/0565/003 Estonia 370702 Co-Diovan, 160/25 mg õhukese polümeerikattega tabletid 00101/0651 Co-Diovan 160/25mg tabsSE/H/0406/004 Estonia 375902 Diovan 160mg õhukese polümeerikattega tabletid 00101/0601 Diovan 160mg tabsSE/H/0406/003 Estonia 376002 Diovan 80mg õhukese polümeerikattega tabletid 00101/0600 Diovan 80mg tabsSE/H/0230/001 Estonia 378402 Symbicort Turbuhaler, 80/4,5 mikrogrammi/annuses, inhalatsioonipulber 17901/0091 Symbicort 100/6 TurbohalerSE/H/0229/001 Estonia 378502 Symbicort Turbuhaler, 160/4,5 mikrogrammi/annuses, inhalatsioonipulber 17901/0092 Symbicort 200/6 TurbohalerSE/H/0565/002 Estonia 380602 Co-Diovan, 160/12,5 mg õhukese polümeerikattega tabletid 00101/0650 Co-Diovan 160/12.5mg tabsDE/H/0299/001 Estonia 429903 Xyzal, 5mg õhukese polümeerikattega tabletid 00039/0539 Xyzal 5mg tabsSE/H/0406/005 Estonia 452504 Diovan 40mg õhukese polümeerikattega tabletid 00101/0599 Diovan 40mg tabsSE/H/0169/003 Estonia 458604 Seretide Diskus 500 10949/0316 Seretide 500 AccuhalerFI/H/0313/001 Estonia 472505 Nebido 1000mg/4ml süstelahus 00010/0549 Nebido 1000mg/4ml injSE/H/0229/002 Estonia 502705 Symbicort Turbuhaler, 320/9 mikrogrammi/annuses, inhalatsioonipulber 17901/0200 Symbicort 400/12 TurbohalerSE/H/1876/001 Estonia 518806 Serevent 25 mikrogrammi/annuses inhaleeritav aerosol, suspension. 10949/0369 Serevent 25 EvohalerNL/H/0156/010 Estonia 565007 Seroquel XR 300mg toimeainet prolongeeritult vabastavad tabletid 50827/0009 Seroquel XL 300mg tabsNL/H/0156/011 Estonia 565207 Seroquel XR 400mg toimeainet prolongeeritult vabastavad tabletid 50827/0010 Seroquel XL 400mg tabsDE/H/5733/001 Estonia 675610 Versatis, 700mg ravimplaaster 21727/0016 Versatis 700mg medicated plasterDE/H/2251/001 Estonia 682110 Combodart, 0,5mg/0,4mg kõvakapslid 19494/0046 Combodart 0.5mg/0.4mg capsDK/H/2871/001 Estonia 696710 Picoprep 03194/0014 PicolaxDE/H/2020/008 Estonia 711310 Palexia retard, 250mg toimeainet prolongeeritult vabastavad tabletid 21727/0045 Palexia SR 250mg tabsDE/H/2020/005 Estonia 711710 Palexia retard, 100mg toimeainet prolongeeritult vabastavad tabletid 21727/0042 Palexia SR 100mg tabsDE/H/2020/006 Estonia 711810 Palexia retard, 150mg toimeainet prolongeeritult vabastavad tabletid 21727/0043 Palexia SR 150mg tabsDE/H/2020/007 Estonia 711910 Palexia retard, 200mg toimeainet prolongeeritult vabastavad tabletid 21727/0044 Palexia SR 200mg tabsDE/H/2020/004 Estonia 712010 Palexia retard, 50mg toimeainet prolongeeritult vabastavad tabletid 21727/0041 Palexia SR 50mg tabsNL/H/0718/001 Estonia 744811 Spiriva Respimat, 2,5 mikrogrammi, inhalatsioonilahus 14598/0084 Spiriva RespimatNL/H/0299/001 Estonia 747811 Spiriva, 18 mikrogrammi, inhalatsioonipulber kõvakapslis 14598/0062 Spiriva 18mcg inhalation powderNL/H/0732/001 Estonia 756111 Mezavant 1200mg gastroresistentsed toimeainet prolongeeritult vabastavad tabletid 08081/0040 Mezavant XL 1200mg tabsDE/H/2020/009 Estonia 784612 Palexia retard, 25mg toimeainet prolongeeritult vabastavad tabletid 21727/0051 Palexia SR 25mg tabsNL/H/0150/001 Estonia 806813 Nexplanon, 68 mg implantaat 00025/0563 NexplanonDE/H/3355/001 Estonia 808513 Dymista 137 mikrogrammi/50 mikrogrammi annuses ninasprei, suspensioon 15142/0258 Dymista Nasal SprayDK/H/0134/003 Estonia 966518 Cosopt sine 20mg/5mg/ml silmatilgad, lahus 16058/0025 Cosopt iMultiSE/H/0404/002 Finland 9145 Renitec 5mg tabletti 00025/0194 Innovace 5mg tabsDE/H/4019/005 Finland 11606 Sandimmun Neoral 100mg/ml oraaliliuos 00101/0390 Neoral 100mg/ml solutionDE/H/4019/002 Finland 11607 Sandimmun Neoral 25mg pehmeät kapselit 00101/0387 Neoral 25mg soft capsDE/H/4019/003 Finland 11608 Sandimmun Neoral 50mg pehmeät kapselit 00101/0388 Neoral 50mg soft capsDE/H/4019/004 Finland 11609 Sandimmun Neoral 100mg pehmeät kapselit 00101/0389 Neoral 100mg soft capsNL/H/1457/002 Finland 11637 Cozaar 50mg kalvopäällysteiset tabletit 00025/0324 Cozaar 50mg tabsNL/H/1458/001 Finland 12140 Cozaar Comp 50mg/12,5mg kalvopäällysteiset tabletit 00025/0338 Cozaar Comp 50mg/12.5mgNL/H/0115/001 Finland 12426 Imigran 10mg nenasumute 10949/0260 Imigran 10mg Nasal SprayNL/H/4790/001 Finland 12469 Zanidip 10 mg kalvopäällysteiset tabletit 04595/0005 Zanidip 10mg tabsIE/H/0838/001 Finland 12546 Sporanox 10mg/ml oraaliliuos 00242/0307 Sporanox LiquidPT/H/2363/001 Finland 12581 Augmentin 80/11,4 mg/ml jauhe oraalisuspensiota varten 10592/0070 Augmentin Duo 400/57DE/H/6157/001 Finland 12694 Xalatan 50 mikrog/ml silmätipat, liuos 00057/1057 Xalatan eye dropsSE/H/1821/001 Finland 12862 Nasonex 50 mikrogrammaa/annos nenäsumute, suspensio 00025/0587 Nasonex 50ug/actuation nasal sprayNL/H/1457/001 Finland 12916 Cozaar 12.5mg kalvopäällysteiset tabletit 00025/0515 Cozaar 12.5mg tabsSE/H/0565/001 Finland 13181 Diovan Comp 80 mg/12,5 mg kalvopäällysteinen tabletti 00101/0480 Co-Diovan 80/12.5mg tabsSE/H/0147/001 Finland 13569 Cerazette 75 mikrog tabletti, kalvopäällysteinen 00025/0562 Cerazette 75mcg tabsNL/H/1458/003 Finland 13738 Cozaar Comp Forte 100mg/25mg kalvopäällysteiset tabletit 00025/0374 Cozaar Comp 100mg/25mgNL/H/0150/001 Finland 13811 Nexplanon 68 mg implantaatti, ihon alle 00025/0563 Nexplanon

Version: 11/11/2020 Page: 12 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductSE/H/0169/001 Finland 13822 Seretide Diskus 50 mikrog / 100 mikrog/annos inhalaatiojauhe, annosteltu 10949/0314 Seretide 100 AccuhalerSE/H/0169/002 Finland 13823 Seretide Diskus 50 mikrog / 250 mikrog/annos inhalaatiojauhe, annosteltu 10949/0315 Seretide 250 AccuhalerSE/H/0169/003 Finland 13824 Seretide Diskus 50 mikrog / 500 mikrog/annos inhalaatiojauhe, annosteltu 10949/0316 Seretide 500 AccuhalerNL/H/0156/001 Finland 14757 Seroquel 25mg tabletti kalvopäällysteinen 50827/0002 Seroquel 25mg tabsNL/H/0156/002 Finland 14758 Seroquel 100mg tabletti kalvopäällysteinen 50827/0003 Seroquel 100mg tabsNL/H/0156/003 Finland 14758 Seroquel 200mg tabletti kalvopäällysteinen 50827/0004 Seroquel 200mg tabsDK/H/0168/002 Finland 14798 Trileptal 300mg 00101/0582 Trileptal 300mg tabsDK/H/0168/003 Finland 14799 Trileptal 600mg 00101/0583 Trileptal 600mg tabsSE/H/1843/001 Finland 15605 Zidoval 7,5mg/g emätingeeli 46302/0153 Zidoval 7.5mg/g Vaginal gelSE/H/0225/001 Finland 15990 Zaditen 0,25 mg/ml silmätipat, liuos 20162/0019 Zaditen 0.25mg/ml eye dropsSE/H/0230/001 Finland 16150 Symbicort Turbuhaler mite inhalaatiojauhe 17901/0091 Symbicort 100/6 TurbohalerSE/H/0229/001 Finland 16151 Symbicort Turbuhaler inhalaatiojauhe 17901/0092 Symbicort 200/6 TurbohalerDE/H/5770/002 Finland 16182 Seretide Evohaler 25 mikrog / 125 mikrog/annos inhalaatiosumute, suspensio 10949/0338 Seretide 125 EvohalerDE/H/5770/003 Finland 16183 Seretide Evohaler 25 mikrog / 250 mikrog/annos inhalaatiosumute, suspensio 10949/0339 Seretide 250 EvohalerDE/H/5646/001 Finland 16382 Caverject Dual 10 mikrogrammaa injektiokuiva-aine ja liuotin, liuosta varten 00057/0939 Caverject DCS 10ugDE/H/5646/002 Finland 16383 Caverject Dual 20 mikrogrammaa injektiokuiva-aine ja liuotin, liuosta varten 00057/0940 Caverject DCS 20ugSE/H/0249/001 Finland 16419 Xalcom 50 mikrog/ml + 5 mg/ml, silmätipat, liuos 00057/1056 Xalacom eye dropsDE/H/0299/001 Finland 16550 Xyzal 5mg kalvopäällysteiset tabletit 00039/0539 Xyzal 5mg tabsNL/H/0156/007 Finland 16559 Seroquel 300mg tabletti kalvopäällysteinen 50827/0005 Seroquel 300mg tabsNL/H/1457/003 Finland 16602 Cozaar 100mg kalvopäällysteiset tabletit 00025/0416 Cozaar 100mg tabsSE/H/0406/003 Finland 16708 Diovan 80mg kalvopäällysteinen tabletti 00101/0600 Diovan 80mg tabsSE/H/0406/004 Finland 16709 Diovan 160mg kalvopäällysteinen tabletti 00101/0601 Diovan 160mg tabsNL/H/0299/001 Finland 17061 Spiriva 18 mikrog inhalaatiojauhe, kapseli, kova 14598/0062 Spiriva 18mcg inhalation powderSE/H/0229/002 Finland 17243 Symbicort Turbuhaler forte inhalaatiojauhe 17901/0200 Symbicort 400/12 TurbohalerNL/H/4790/002 Finland 17837 Zanidip 20 mg kalvopäällysteiset tabletit 04595/0010 Zanidip 20mg tabsFI/H/0313/001 Finland 17857 Nebido 1000mg/4ml injektioneste liuos 00010/0549 Nebido 1000mg/4ml injDE/H/0384/001 Finland 17889 Olmetec 10mg tabletti, kalvopäällysteinen 08265/0015 Olmetec 10mg tabsDE/H/0384/002 Finland 17890 Olmetec 20mg tabletti, kalvopäällysteinen 08265/0016 Olmetec 20mg tabsDE/H/0384/003 Finland 17891 Olmetec 40mg tabletti, kalvopäällysteinen 08265/0017 Olmetec 40mg tabsSE/H/0565/002 Finland 18231 Diovan Comp 160 mg/12,5 mg kalvopäällysteinen tabletti 00101/0650 Co-Diovan 160/12.5mg tabsDK/H/2888/001 Finland 19257 Equasym Retard 10mg depotkapseli, kova 27303/0004 Equasym XL 10mg capsDK/H/2888/002 Finland 19258 Equasym Retard 20mg depotkapseli, kova 27303/0005 Equasym XL 20mg capsDK/H/2888/003 Finland 19259 Equasym Retard 30mg depotkapseli, kova 27303/0006 Equasym XL 30mg capsSE/H/0565/003 Finland 19618 Diovan Comp 160 mg/25 mg kalvopäällysteinen tabletti 00101/0651 Co-Diovan 160/25mg tabsSE/H/0406/005 Finland 20510 Diovan 40mg kalvopäällysteinen tabletti 00101/0599 Diovan 40mg tabsFI/H/0981/001 Finland 21022 Tobrasone 3 mg/ml + 1 mg/ml silmätipat, suspensio 00101/1007 Tobradex eye dropsNL/H/1458/002 Finland 21023 Cozaar Comp 100mg/12,5mg kalvopäällysteiset tabletit 00025/0473 Cozaar Comp 100mg/12.5mgDE/H/0523/001 Finland 21332 Olmetec 20mg/12,5mg tabletti, kalvopäällysteinen 08265/0022 Olmetec Plus 20mg/12.5mg tabsDE/H/0523/002 Finland 21333 Olmetec 20mg/25mg tabletti, kalvopäällysteinen 08265/0023 Olmetec Plus 20mg/25mg tabsDE/H/6220/001 Finland 21375 Malarone 250 mg/100 mg tabletti, kalvopäällysteinen 10949/0258 Malarone tabsNL/H/0732/001 Finland 21895 Mezavant 1200mg enterodepottabletti 08081/0040 Mezavant XL 1200mg tabsDE/H/0690/001 Finland 22209 Medikinet 5mg tabletti 11243/0002 Medikinet 5mg tabsDE/H/0690/002 Finland 22210 Medikinet 10mg tabletti 11243/0003 Medikinet 10mg tabsDE/H/0690/003 Finland 22211 Medikinet 20mg tabletti 11243/0004 Medikinet 20mg tabsDE/H/0690/004 Finland 22212 Medikinet CR 10 mg depotkapseli, kova 11243/0005 Medikinet XL 10mg capsDE/H/0690/005 Finland 22213 Medikinet CR 20 mg depotkapseli, kova 11243/0006 Medikinet XL 20mg capsDE/H/0690/006 Finland 22214 Medikinet CR 30 mg depotkapseli, kova 11243/0007 Medikinet XL 30mg capsDE/H/0690/007 Finland 22215 Medikinet CR 40 mg depotkapseli, kova 11243/0008 Medikinet XL 40mg caps

Version: 11/11/2020 Page: 13 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductNL/H/0718/001 Finland 22537 Spiriva Respimat 2.5 mikrog inhalaationeste 14598/0084 Spiriva RespimatNL/H/0156/008 Finland 24064 Seroquel Prolong 50mg depottabletti 50827/0006 Seroquel XL 50mg tabsNL/H/0156/009 Finland 24065 Seroquel Prolong 200mg depottabletti 50827/0008 Seroquel XL 200mg tabsNL/H/0156/010 Finland 24066 Seroquel Prolong 300mg depottabletti 50827/0009 Seroquel XL 300mg tabsNL/H/0156/011 Finland 24067 Seroquel Prolong 400mg depottabletti 50827/0010 Seroquel XL 400mg tabsNL/H/0156/012 Finland 24948 Seroquel Prolong 150mg depottabletti 50827/0007 Seroquel XL 150mg tabsDE/H/2251/001 Finland 27116 Duodart 0,5mg/0,4mg kovat kapselit 19494/0046 Combodart 0.5mg/0.4mg capsDE/H/0523/003 Finland 27135 Olmetec 40mg/12,5mg tabletti, kalvopäällysteinen 08265/0029 Olmetec Plus 40mg/12.5mg tabsDE/H/0523/004 Finland 27136 Olmetec 40mg/25mg tabletti, kalvopäällysteinen 08265/0030 Olmetec Plus 40mg/25mg tabsDE/H/2020/004 Finland 27583 Palexia Depot 50mg depottabletti 21727/0041 Palexia SR 50mg tabsDE/H/2020/005 Finland 27584 Palexia Depot 100mg depottabletti 21727/0042 Palexia SR 100mg tabsDE/H/2020/006 Finland 27585 Palexia Depot 150mg depottabletti 21727/0043 Palexia SR 150mg tabsDE/H/2020/007 Finland 27586 Palexia Depot 200mg depottabletti 21727/0044 Palexia SR 200mg tabsDE/H/2020/008 Finland 27587 Palexia Depot 250mg depottabletti 21727/0045 Palexia SR 250mg tabsSE/H/0908/001 Finland 28107 Jext 150 mikrogrammaa injektioneste, liuos, esitäytetty kynä 10085/0052 Jext 150mcg PenSE/H/0908/002 Finland 28108 Jext 300 mikrogrammaa injektioneste, liuos, esitäytetty kynä 10085/0053 Jext 300mcg PenDK/H/2871/001 Finland 28275 Picoprep 03194/0014 PicolaxDE/H/2915/001 Finland 28923 Latanoprost Pfizer 50 mikrogrammaa/ml silmätipat, liuos 00057/1221 Latanoprost Pfizer 50ug/ml eye dropsDE/H/0690/008 Finland 28970 Medikinet CR 5 mg depotkapseli, kova 11243/0010 Medikinet XL 5mg capsDK/H/2028/001 Finland 29471 Methylphenidate Sandoz 18mg depottabletit 04416/1346 Matoride XL 18mg tabsDK/H/2028/002 Finland 29472 Methylphenidate Sandoz 36mg depottabletit 04416/1348 Matoride XL 36mg tabsDK/H/2028/003 Finland 29473 Methylphenidate Sandoz 54mg depottabletit 04416/1349 Matoride XL 54mg tabsSE/H/1074/001 Finland 29604 Latanoprost/Timolol Pfizer 50 mikrog/ml + 5 mg/ml, silmätipat, liuos 00057/1322 Latanoprost/Timolol Pfizer 50+5 ug/mlDE/H/2020/009 Finland 29798 Palexia Depot 25mg depottabletti 21727/0051 Palexia SR 25mg tabsDE/H/3355/001 Finland 30255 Dymista 125 mikrogrammaa + 50 mikrogrammaa / annos nenäsumute, suspensio 15142/0258 Dymista Nasal SprayDK/H/2888/004 Finland 30420 Equasym Retard 40mg depotkapseli, kova 27303/0007 Equasym XL 40mg capsDK/H/2888/005 Finland 30421 Equasym Retard 50mg depotkapseli, kova 27303/0008 Equasym XL 50mg capsDK/H/2888/006 Finland 30422 Equasym Retard 60mg depotkapseli, kova 27303/0009 Equasym XL 60mg capsNL/H/2564/001 Finland 30768 Propranolol Accord 10mg kalvopäällysteiset tabletit 20075/0360 Propranolol 10mg tabsNL/H/2564/002 Finland 30769 Propranolol Accord 40mg kalvopäällysteiset tabletit 20075/0361 Propranolol 40mg tabsSE/H/0404/002 France 327 089.8 Renitec 5mg comprime secable 00025/0194 Innovace 5mg tabsDE/H/0899/001 France 337 898.6 Neutontin 100mg 00057/0535 Neurontin 100mg capsDE/H/0899/003 France 338 014.4 Neurontin 400mg 00057/0537 Neurontin 400mg capsBG/H/0132/001 France 34009 221 009 0 6 Lercanidipine Teva Sante 10mg comprimé pelliculé sécable 00289/1438 Lercanidipine hydrochloride 10mg tabsBG/H/0132/001 France 34009 221 013 8 5 Lercanidipine Teva Sante 10mg comprimé pelliculé sécable 00289/1438 Lercanidipine hydrochloride 10mg tabsBG/H/0132/002 France 34009 221 028 5 6 Lercanidipine Teva Sante 20mg comprimé pelliculé sécable 00289/1439 Lercanidipine hydrochloride 20mg tabsBG/H/0132/002 France 34009 221 033 9 6 Lercanidipine Teva Sante 20mg comprimé pelliculé sécable 00289/1439 Lercanidipine hydrochloride 20mg tabsDE/H/2915/001 France 34009 223 761 1 0 Latanoprost Pfizer 50 microgrammes/ml, collyre en solution 00057/1221 Latanoprost Pfizer 50ug/ml eye dropsDE/H/2915/001 France 34009 223 762 8 8 Latanoprost Pfizer 50 microgrammes/ml, collyre en solution 00057/1221 Latanoprost Pfizer 50ug/ml eye dropsDE/H/3337/001 France 34009 224 397 16 Ciloxadex 3mg / 1 mg par ml, Suspension pour instillation auriculaire 15011/0026 Cilodex 3mg/ml 1mg/ml ear dropsSE/H/1421/003 France 34009 258 586 3 4 Vivelledot 75 microgrammes/24 heures dispositif transdermique 00101/0644 Estradot 75ug/24hDE/H/0871/002 France 34009 266 362 1 0 Innovair Nexthaler 100 microgrammes/6 microgrammes par dose, poudre pour inhalati 08829/0173 Fostair Nexthaler 100/6SE/H/1921/001 France 34009 266 487 9 4 Flutiform 50 microgrammes/5 microgrammes par dose, suspension pour inhalation en f16950/0167 Flutiform 50mcg/5mcg inhalerSE/H/1921/002 France 34009 266 488 5 5 Flutiform 125 microgrammes/5 microgrammes par dose, suspension pour inhalation en16950/0168 Flutiform 125mcg/5mcg inhalerSE/H/1921/003 France 34009 266 489 1 6 Flutiform 250 microgrammes/10 microgrammes par dose, suspension pour inhalation e16950/0169 Flutiform 250mcg/10mcg inhalerBE/H/0150/001 France 34009 273 690 0 1 Setofilm Ge 4 mg film orodispersible 21042/0011 Setofilm 4mg Orodispersible filmsNL/H/2379/002 France 34009 275 438 7 6 Vitaros 300 microgrammes, creme 03194/0125 Vitaros 3mg/g creamDE/H/3355/001 France 34009 275 631 1 9 Dymista 137 microgrammes/50 microgrammes, suspension pour pulvérisation nasale 15142/0258 Dymista Nasal Spray

Version: 11/11/2020 Page: 14 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductIT/H/03080/001 France 34009 275 660 1 1 Teglutik 5mg/ml suspension buvable 20663/0002 Teglutik 5mg/ml suspensionDE/H/2805/001 France 34009 275 700 3 2 Trospipharm 20 mg, comprimé pelliculé 25258/0108 Trospium chloride 20mg tabs DE/H/2805/001 France 34009 275 700 32 Trospipharm 20mg, comprimé pelliculé 25258/0108 Trospium chloride 20mg tabsNL/H/0343/001 France 34009 276 105 1 6 Crestor 10mg 17901/0201 Crestor 10mg tabsNL/H/0343/002 France 34009 276 106 8 4 Crestor 20mg comprimé pelliculé 17901/0202 Crestor 20mg tabsFI/H/0313/001 France 34009 277 134 5 3 Nebido 1000mg/4ml solution injectable 00010/0549 Nebido 1000mg/4ml injNL/H/2498/001 France 34009 277 232 7 8 Striverdi Respimat 2,5 microgrammes/dose, solution pour inhalation 14598/0093 Striverdi Respimat DK/H/0279/002 France 34009 279 460 7 3 Daivobet 50 microgrammes/0.5 mg/g gel 05293/0005 Dovobet gelDK/H/2478/001 France 34009 300 749 8 5 Enstilar 50 microgrammes/0,5mg/g mousse cutanee 05293/0008 Enstilar 50mcg/g+0.5mg/g foamDK/H/2638/001 France 34009 301 051 7 7 Travoprost/Timolol Mylan 40 mcg/ml + 5mg/ml collyre en solution 04569/1683 Travoprost/Timolol Mylan eye dropsNL/H/3441/001 France 34009 301 336 2 0 Calcipotriol-Betamethasone Sandoz 50 microgrammes-0,5 mg-g pommade 04416/1449 Calcipotriol/Betamethasone 50/500ug/g DK/H/0134/001 France 34009 301 663 4 5 Cosopt 20mg/ml+5mg/ml collyre en solution 16058/0016 Cosopt solutionDE/H/0899/002 France 34009 337 901 7 2 Neurontin 300mg 50622/0047 Neurontin 300mg capsNL/H/1458/001 France 34009 338 520 7 8 Hyzaar 50mg/12.5mg comprimé pelliculé 00025/0338 Cozaar Comp 50mg/12.5mgNL/H/1457/002 France 34009 338 524 2 9 Cozaar 50mg comprimé pelliculé sécable 00025/0324 Cozaar 50mg tabsFR/H/0118/001 France 34009 341 752 2 0 Siccafluid 2.5mg/g gel ophtalmique 20162/0009 Liquivisc 2.5mg/g eye gelNL/H/3915/002 France 34009 342 383 0 7 Durogesic 25 microgrammes/heure, dispositif transdermique 00242/0192 Durogesic DTrans 25ug/hrNL/H/3915/003 France 34009 342 384 7 5 Durogesic 50 microgrammes/heure, dispositif transdermique 00242/0193 Durogesic DTrans 50ug/hrNL/H/3915/004 France 34009 342 385 3 6 Durogesic 75 microgrammes/heure, dispositif transdermique 00242/0194 Durogesic DTrans 75ug/hrNL/H/3915/005 France 34009 342 386 6 5 Durogesic 100 microgrammes/heure, dispositif transdermique 00242/0195 Durogesic DTrans 100ug/hrSE/H/1821/001 France 34009 343 012 6 1 Nasonex 50 microgrammes/dose, suspension pour pulvérisation nasale 00025/0587 Nasonex 50ug/actuation nasal sprayDE/H/6157/001 France 34009 343 840 6 6 Xalatan 50 microgrammes/ml, collyre en solution 00057/1057 Xalatan eye dropsDE/H/4019/004 France 34009 346 301 9 4 Sandimmun 100mg capsule molle 00101/0389 Neoral 100mg soft capsDE/H/4019/002 France 34009 346 302 5 5 Sandimmun 25mg capsule molle 00101/0387 Neoral 25mg soft capsDE/H/4019/003 France 34009 346 303 1 6 Sandimmun 50mg capsule molle 00101/0388 Neoral 50mg soft capsNL/H/0144/004 France 34009 347 941 1 7 Maxalt LYO 10mg Lyophilisat oral 00025/0372 Maxalt Melt 10mgNL/H/0144/004 France 34009 347 943 4 6 Maxalt LYO 10mg Lyophilisat oral 00025/0372 Maxalt Melt 10mgNL/H/0144/004 France 34009 347 944 0 7 Maxalt LYO 10mg Lyophilisat oral 00025/0372 Maxalt Melt 10mgDK/H/0134/001 France 34009 348 063 8 4 Cosopt 20mg/ml+5mg/ml collyre en solution 16058/0016 Cosopt solutionDE/H/0523/003 France 34009 350 245 2 7 CoOlmetec 40mg/12,5mg comprime pellicule 08265/0029 Olmetec Plus 40mg/12.5mg tabsDE/H/0523/003 France 34009 350 246 9 5 CoOlmetec 40mg/12,5mg comprime pellicule 08265/0029 Olmetec Plus 40mg/12.5mg tabsDE/H/0523/004 France 34009 350 247 5 6 CoOlmetec 40mg/25mg comprime pellicule 08265/0030 Olmetec Plus 40mg/25mg tabsDE/H/0523/004 France 34009 350 248 1 7 CoOlmetec 40mg/25mg comprime pellicule 08265/0030 Olmetec Plus 40mg/25mg tabsPT/H/2325/002 France 34009 350 838 3 8 Tanatril 5mg comprimé sécable 20012/0004 Tanatril 5mg tabsPT/H/2325/003 France 34009 350 847 2 9 Tanatril 10mg comprimé sécable 20012/0005 Tanatril 10mg tabsNL/H/0150/001 France 34009 351 544 3 9 Nexplanon 68 mg, implant pour usage sous-cutané 00025/0563 NexplanonNL/H/1458/003 France 34009 351 862 5 6 Fortzaar 100mg/25mg comprimé pelliculé 00025/0374 Cozaar Comp 100mg/25mgPT/H/2396/001 France 34009 352 317 0 3 Otrasel 1.25 mg Oral Lyophilisate 16260/0031 Zelapar 1.25mg lyophilisatesDK/H/0168/001 France 34009 353 570 1 4 Trileptal 150mg comprime 00101/0581 Trileptal 150mg tabsSE/H/0198/001 France 34009 354 368 1 8 Celebrex 100mg gelule 50622/0011 Celebrex 100mg capsSE/H/0198/002 France 34009 354 370 6 8 Celebrex 200mg gelule 50622/0012 Celebrex 200mg capsSE/H/0169/001 France 34009 354 593 5 0 Seretide Diskus 100 microgrammes/50 microgrammes/dose, poudre pour inhalation 10949/0314 Seretide 100 AccuhalerSE/H/0169/002 France 34009 354 597 0 1 Seretide Diskus 250 microgrammes/50 microgrammes/dose, poudre pour inhalation 10949/0315 Seretide 250 AccuhalerSE/H/0169/003 France 34009 354 735 4 7 Seretide Diskus 500 microgrammes/50 microgrammes/dose, poudre pour inhalation 10949/0316 Seretide 500 AccuhalerFR/H/0178/001 France 34009 355 311 3 1 Femseptcombi 50ug/10ug/24heurs, dispositif transdermique 49876/0011 FemSeven Sequi patchesSE/H/0211/001 France 34009 355 332 0 3 INexium 20mg comprimes gastro-resistants 17901/0068 Nexium 20mg tabsSE/H/0211/001 France 34009 355 333 7 1 INexium 20mg comprimes gastro-resistants 17901/0068 Nexium 20mg tabsSE/H/0211/001 France 34009 355 334 3 2 INexium 20mg comprimes gastro-resistants 17901/0068 Nexium 20mg tabs

Version: 11/11/2020 Page: 15 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductSE/H/0211/002 France 34009 355 339 5 1 INEXIUM 40 mg, comprime gastro-resistant 17901/0069 Nexium 40mg tabsSE/H/0210/004 France 34009 355 372 2 5 Reminyl 4 mg/ml solution buvable 08557/0042 Reminyl 4mg/ml solnDE/H/0235/001 France 34009 355 373 9 3 Lipanthyl 160mg comprimé pelliculé 46302/0024 Supralip 160mg tabsSE/H/0225/001 France 34009 356 074 5 4 Zalergonium, 0,25 mg/ml, collyre en solution 20162/0019 Zaditen 0.25mg/ml eye dropsSE/H/0230/001 France 34009 356 582 0 3 Symbicort Turbuhaler 100/6 microgrammes par dose, poudre pour inhalation 17901/0091 Symbicort 100/6 TurbohalerSE/H/0229/001 France 34009 356 584 3 2 Symbicort Turbuhaler 200/6 microgrammes par dose, poudre pour inhalation 17901/0092 Symbicort 200/6 TurbohalerDE/H/5770/002 France 34009 356 587 2 2 Seretide 125 microgrammes/25 microgrammes/dose, suspension pour inhalation 10949/0338 Seretide 125 EvohalerDE/H/5770/003 France 34009 356 588 9 0 Seretide 250 microgrammes/25 microgrammes/dose, suspension pour inhalation 10949/0339 Seretide 250 EvohalerSE/H/0202/001 France 34009 357 849 0 2 Duova 1mg/2.5mg, comprime 27925/0011 Indivina 1mg/2.5mg tabsSE/H/0202/003 France 34009 357 853 8 1 Duova 2mg/5mg, comprime 27925/0013 Indivina 2mg/5mg tabsSE/H/0202/003 France 34009 357 854 4 2 Duova 2mg/5mg, comprime 27925/0013 Indivina 2mg/5mg tabsNL/H/4583/002 France 34009 357 868 5 2 Relpax 40mg 50622/0054 Relpax 40mg tabsDK/H/0168/004 France 34009 357 901 2 5 Trileptal 60mg/ml suspension buvable 00101/0631 Trileptal 60mg/ml suspensionNL/H/1457/003 France 34009 358 495 8 8 Cozaar 100mg comprimé pelliculé 00025/0416 Cozaar 100mg tabsDE/H/0299/001 France 34009 358 502 4 9 Xyzall 5mg, comprimé pelliculé 00039/0539 Xyzal 5mg tabsDE/H/0299/001 France 34009 358 505 3 9 Xyzall 5mg, comprimé pelliculé 00039/0539 Xyzal 5mg tabsSE/H/1421/004 France 34009 358 590 0 6 Vivelledot 100 microgrammes/24 heures 00101/0645 Estradot 100ug/24hSE/H/0278/002 France 34009 359 937 4 8 Seroplex 10 mg comprime pellicule secable 13761/0009 Cipralex 10mg tabsSE/H/0229/002 France 34009 359 973 0 2 Symbicort Turbuhaler 400/12 microgrammes par dose, poudre pour inhalation 17901/0200 Symbicort 400/12 TurbohalerDE/H/0769/002 France 34009 360 381 6 5 Ecazide comprimé sécable 00034/0263 Capozide tabsDK/H/0279/001 France 34009 360 826 8 7 Daivobet 50 microgrammes/0,5mg/g pommade 05293/0003 Dovobet ointmentDE/H/6007/003 France 34009 361 556 4 0 Concerta LP 54mg, comprime a liberation prolongee 00242/0374 Concerta XL 54mg tabsSE/H/0304/001 France 34009 361 825 5 4 Avodart 0.5mg capsule molle 19494/0006 Avodart 0.5mg soft capsDE/H/5646/001 France 34009 361 975 7 2 CaverjectDual 10 microgrammes/0,5 ml, poudre et solvant pour solution injectable en c00057/0939 Caverject DCS 10ugDE/H/5646/002 France 34009 361 978 6 2 CaverjectDual 20 microgrammes/0,5 ml, poudre et solvant pour solution injectable en c00057/0940 Caverject DCS 20ugNL/H/0343/001 France 34009 362 071 4 1 Crestor 10mg 17901/0201 Crestor 10mg tabsNL/H/0343/002 France 34009 362 076 6 0 Crestor 20mg comprimé pelliculé 17901/0202 Crestor 20mg tabsDE/H/0384/001 France 34009 362 321 0 5 Olmetec 10mg comprime pellicule 08265/0015 Olmetec 10mg tabsDE/H/0384/002 France 34009 362 326 2 4 Olmetec 20mg comprime pellicule 08265/0016 Olmetec 20mg tabsDE/H/0384/003 France 34009 362 331 6 4 Olmetec 40mg comprime pellicule 08265/0017 Olmetec 40mg tabsFR/H/0258/002 France 34009 364 450 2 4 Adartrel 0.5mg comprimes pellicules 19494/0034 Adartrel 0.5mg tabsFR/H/0258/004 France 34009 364 454 8 2 Adartrel 2mg comprimes pellicules 19494/0036 Adartrel 2mg tabsNL/H/0487/001 France 34009 365 515 0 3 Vesicare 5mg, comprime pellicule 00166/0197 Vesicare 5mg tabsNL/H/0487/002 France 34009 365 516 7 1 Vesicare 10 mg comprime pellicule 00166/0198 Vesicare 10mg tabsFR/H/0112/001 France 34009 365 727 8 2 Wellvone 750 mg/5ml Suspension buvable 10949/0271 Wellvone 750mg/5ml oral suspSE/H/0210/005 France 34009 367 593 9 8 Reminyl LP 8mg gelule a liberation prolongee 08557/0052 Reminyl XL 8mg capsFR/H/0685/001 France 34009 367 594 5 9 Femseptevo 50 microgrammes/7 microgrammes/24 heures, dispositif transdermique 49876/0010 FemSeven Conti patchesSE/H/0210/006 France 34009 367 595 1 0 Reminyl LP 16mg gelule a liberation prolongee 08557/0053 Reminyl XL 16mg capsSE/H/0210/007 France 34009 367 596 8 8 Reminyl LP 24mg gelule a liberation prolongee 08557/0054 Reminyl XL 24mg capsFR/H/0272/001 France 34009 368 097 5 8 Monotramal LP 100mg comprimé à libération prolongée 43808/0001 Tradorec XL 100mg tabsFR/H/0272/002 France 34009 368 107 0 9 Monotramal LP 200mg comprimé à libération prolongée 43808/0002 Tradorec XL 200mg tabsFR/H/0272/003 France 34009 368 124 2 0 Monotramal LP 300mg comprimé à libération prolongée 43808/0003 Tradorec XL 300mg tabs

NL/H/0299/001 France 34009 368 692 0 2 Spiriva 18 microgrammes, poudre pour inhalation en gélule 14598/0062 Spiriva 18mcg inhalation powderSE/H/0481/004 France 34009 369 290 36 Fosrenol 1000mg comprimé à croquer 08081/0044 Fosrenol 1000mg tabsNL/H/3915/001 France 34009 369 851 5 5 Durogesic 12 microgrammes/heure, dispositif transdermique 00242/0409 Durogesic DTrans 12ug/hrNL/H/0343/004 France 34009 369 853 8 4 Crestor 5mg 17901/0243 Crestor 5mg tabsNL/H/1458/003 France 34009 371 408 8 1 Fortzaar 100mg/25mg comprimé pelliculé 00025/0374 Cozaar Comp 100mg/25mgNL/H/1458/001 France 34009 371 446 7 4 Hyzaar 50mg/12.5mg comprimé pelliculé 00025/0338 Cozaar Comp 50mg/12.5mg

Version: 11/11/2020 Page: 16 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductNL/H/1457/003 France 34009 371 449 6 4 Cozaar 100mg comprimé pelliculé 00025/0416 Cozaar 100mg tabsNL/H/1457/002 France 34009 371 461 6 6 Cozaar 50mg comprimé pelliculé sécable 00025/0324 Cozaar 50mg tabsDE/H/0235/001 France 34009 371 780 4 4 Lipanthyl 160mg comprimé pelliculé 46302/0024 Supralip 160mg tabsSE/H/0565/002 France 34009 372 013 7 7 Cotareg 160 mg/12,5 mg, comprimé pelliculé 00101/0650 Co-Diovan 160/12.5mg tabsDE/H/0523/001 France 34009 372 210 7 8 CoOlmetec 20mg/12,5mg comprime pellicule 08265/0022 Olmetec Plus 20mg/12.5mg tabsDE/H/0523/001 France 34009 372 211 3 9 CoOlmetec 20mg/12,5mg comprime pellicule 08265/0022 Olmetec Plus 20mg/12.5mg tabsDE/H/0523/002 France 34009 372 213 6 8 CoOlmetec 20mg/25mg comprime pellicule 08265/0023 Olmetec Plus 20mg/25mg tabsDE/H/0523/002 France 34009 372 214 2 9 CoOlmetec 20mg/25mg comprime pellicule 08265/0023 Olmetec Plus 20mg/25mg tabsCZ/H/0939/001 France 34009 373 075 6 7 Levonorgestrel Biogaran 1500 microgrammes comprime 04854/0150 Levonelle 1500mcg tabsDE/H/0384/001 France 34009 374 014 0 1 Olmetec 10mg comprime pellicule 08265/0015 Olmetec 10mg tabsDE/H/0384/001 France 34009 374 016 3 0 Olmetec 10mg comprime pellicule 08265/0015 Olmetec 10mg tabsDE/H/0384/002 France 34009 374 018 6 9 Olmetec 20mg comprime pellicule 08265/0016 Olmetec 20mg tabsDE/H/0384/002 France 34009 374 020 0 2 Olmetec 20mg comprime pellicule 08265/0016 Olmetec 20mg tabsDE/H/0384/003 France 34009 374 021 7 0 Olmetec 40mg comprime pellicule 08265/0017 Olmetec 40mg tabsDE/H/0384/003 France 34009 374 024 6 0 Olmetec 40mg comprime pellicule 08265/0017 Olmetec 40mg tabsNL/H/0653/001 France 34009 374 776 80 Dexafree 1mg/ml collyre en solution en recipient unidose 20162/0013 Dexafree 1mg/ml eye dropsDK/H/0134/002 France 34009 377 057 2 1 Cosopt 20mg/ml+5mg/ml collyre en solution en recipient unidose 16058/0015 Cosopt SDUNL/H/1458/002 France 34009 377 484 8 3 Fortzaar 100mg/12.5mg comprimé pelliculé 00025/0473 Cozaar Comp 100mg/12.5mgNL/H/1458/002 France 34009 377 488 3 4 Fortzaar 100mg/12.5mg comprimé pelliculé 00025/0473 Cozaar Comp 100mg/12.5mgSE/H/0612/001 France 34009 378 011 6 4 Grazax 75 000 SQ-T lyophilisat oral 10085/0039 Grazax 75000SQ-T oral lyophilisateSE/H/0612/001 France 34009 378 012 2 5 Grazax 75 000 SQ-T lyophilisat oral 10085/0039 Grazax 75000SQ-T oral lyophilisateSE/H/1800/001 France 34009 378 816 47 Moviprep poudre pour solution buvable en sachets 20011/0039 Moviprep, powder for oral solnDE/H/0871/001 France 34009 381 412 8 3 Innovair 100/6 microgrammes/dose, solution pour inhalation en flacon pressurisé 08829/0156 Fostair 100/6 inhalerSE/H/0612/001 France 34009 381 472 0 9 Grazax 75 000 SQ-T lyophilisat oral 10085/0039 Grazax 75000SQ-T oral lyophilisateSE/H/0406/005 France 34009 381 540 6 1 Tareg 40mg comprime pellicule 00101/0599 Diovan 40mg tabsSE/H/0406/005 France 34009 381 541 2 2 Tareg 40mg comprime pellicule 00101/0599 Diovan 40mg tabsSE/H/0406/003 France 34009 381 546 4 1 Tareg 80mg comprime pellicule 00101/0600 Diovan 80mg tabsSE/H/0406/004 France 34009 381 552 4 2 Tareg 160mg comprime pellicule 00101/0601 Diovan 160mg tabsSE/H/0565/001 France 34009 381 558 2 2 Cotareg 80 mg/12,5 mg, comprimé pelliculé 00101/0480 Co-Diovan 80/12.5mg tabsSE/H/0565/001 France 34009 381 560 7 2 Cotareg 80 mg/12,5 mg, comprimé pelliculé 00101/0480 Co-Diovan 80/12.5mg tabsSE/H/0565/002 France 34009 381 568 8 1 Cotareg 160 mg/12,5 mg, comprimé pelliculé 00101/0650 Co-Diovan 160/12.5mg tabsSE/H/0565/003 France 34009 381 573 1 4 Cotareg 160 mg/25 mg, comprimé pelliculé 00101/0651 Co-Diovan 160/25mg tabsSE/H/0565/003 France 34009 381 575 4 3 Cotareg 160 mg/25 mg, comprimé pelliculé 00101/0651 Co-Diovan 160/25mg tabsNL/H/0718/001 France 34009 381 920 3 2 Spiriva Respimat 2,5 microgrammes/dose solution pour inhalation 14598/0084 Spiriva RespimatDE/H/5733/001 France 34009 382 856 7 3 Versatis 700mg emplâtre médicamenteux 21727/0016 Versatis 700mg medicated plasterSE/H/0581/001 France 34009 384 446 0 5 Venlafaxine Abbott 37.5mg comprimé à libération prolongée 01883/0338 Venlalic XL 37.5mg tabsSE/H/0581/002 France 34009 384 467 8 4 Venlafaxine Abbott 75mg comprimé à libération prolongée 01883/0339 Venlalic XL 75mg tabsSE/H/0581/003 France 34009 384 487 9 5 Venlafaxine Abbott 150mg comprimé à libération prolongée 01883/0340 Venlalic XL 150mg tabsSE/H/0581/004 France 34009 384 506 3 7 Venlafaxine Abbott 225mg comprimé à libération prolongée 01883/0341 Venlalic XL 225mg tabsDK/H/1113/004 France 34009 384 737 59 Trandolapril Mylan 4mg 04569/0820 Trandolapril 4mg capsDK/H/1113/004 France 34009 384 741 21 Trandolapril Mylan 4mg 04569/0820 Trandolapril 4mg capsPT/H/2299/004 France 34009 387 980 8 1 Arcoxia 30 mg comprime pellicule 00025/0641 Arcoxia 30mg tabsNL/H/1113/003 France 34009 388 574 36 Sevikar 40mg/10mg comprime pellicule 08265/0028 Sevikar 40mg/10mg tabsNL/H/1113/003 France 34009 388 577 26 Sevikar 40mg/10mg comprime pellicule 08265/0028 Sevikar 40mg/10mg tabsNL/H/1113/001 France 34009 388 582 66 Sevikar 20mg/5mg comprime pellicule 08265/0026 Sevikar 20mg/5mg tabsNL/H/1113/001 France 34009 388 584 95 Sevikar 20mg/5mg comprime pellicule 08265/0026 Sevikar 20mg/5mg tabsDE/H/2251/001 France 34009 389 339 8 7 Combodart 0,5mg/0,4mg gélule 19494/0046 Combodart 0.5mg/0.4mg capsDK/H/1377/002 France 34009 389 602 0 4 Toctino 30mg capsule molle 19494//0253 Toctino 30mg soft caps

Version: 11/11/2020 Page: 17 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductDK/H/1377/002 France 34009 389 603 7 2 Toctino 30mg capsule molle 19494//0253 Toctino 30mg soft capsDK/H/0279/002 France 34009 389 693 6 8 Daivobet 50 microgrammes/0.5 mg/g gel 05293/0005 Dovobet gelFR/H/0181/004 France 34009 390 152 5 5 Glucophage 500mg poudre pour solution buvable en sachet-dose 11648/0088 Glucophage 500mg powder for solutionFR/H/0181/006 France 34009 390 160 8 5 Glucophage 1000mg poudre pour solution buvable en sachet-dose 11648/0090 Glucophage 1000mg powder for solutionNL/H/0343/004 France 34009 391 690 0 2 Crestor 5mg 17901/0243 Crestor 5mg tabsNL/H/0343/001 France 34009 391 694 6 0 Crestor 10mg 17901/0201 Crestor 10mg tabsNL/H/0343/001 France 34009 391 696 9 9 Crestor 10mg 17901/0201 Crestor 10mg tabsNL/H/0343/002 France 34009 391 697 5 0 Crestor 20mg comprimé pelliculé 17901/0202 Crestor 20mg tabsNL/H/0343/002 France 34009 391 699 8 9 Crestor 20mg comprimé pelliculé 17901/0202 Crestor 20mg tabsFR/H/0258/001 France 34009 391 839 4 7 Adartrel 0.25mg comprimes pellicules 19494/0033 Adartrel 0.25mg tabsFR/H/0258/002 France 34009 391 840 2 9 Adartrel 0.5mg comprimes pellicules 19494/0034 Adartrel 0.5mg tabsFR/H/0258/004 France 34009 391 844 8 7 Adartrel 2mg comprimes pellicules 19494/0036 Adartrel 2mg tabsDE/H/0769/002 France 34009 397 489 5 5 Ecazide comprimé sécable 00034/0263 Capozide tabsNL/H/2081/002 France 34009 418 590 1 4 Mopral 20mg, gelule gastro-resistante 17901/0133 Losec 20mg capsDK/H/2871/001 France 34009 491 722 1 4 Picoprep 03194/0014 PicolaxDK/H/2888/001 France 34009 497 261 6 5 Quasym LP 10mg gélule à libération modifiée 27303/0004 Equasym XL 10mg capsDK/H/2888/002 France 34009 497 262 2 6 Quasym LP 20mg gélule à libération modifiée 27303/0005 Equasym XL 20mg capsDK/H/2888/003 France 34009 497 267 4 5 Quasym LP 30mg gélule à libération modifiée 27303/0006 Equasym XL 30mg capsSE/H/0908/001 France 34009 498 549 3 6 Jext 150 microgrammes, solution injectable en stylo prérempli 10085/0052 Jext 150mcg PenSE/H/0908/002 France 34009 498 550 1 8 Jext 300 microgrammes, solution injectable en stylo prérempli 10085/0053 Jext 300mcg PenNL/H/1457/002 France 34009 558 452 0 1 Cozaar 50mg comprimé pelliculé sécable 00025/0324 Cozaar 50mg tabsNL/H/1458/001 France 34009 558 453 7 9 Hyzaar 50mg/12.5mg comprimé pelliculé 00025/0338 Cozaar Comp 50mg/12.5mgSE/H/0198/001 France 34009 562 715 2 8 Celebrex 100mg gelule 50622/0011 Celebrex 100mg capsSE/H/0198/002 France 34009 562 805 1 3 Celebrex 200mg gelule 50622/0012 Celebrex 200mg capsNL/H/0299/001 France 34009 570 762 6 9 Spiriva 18 microgrammes, poudre pour inhalation en gélule 14598/0062 Spiriva 18mcg inhalation powderSE/H/0110/002 France 341 224.6 Epitomax 50mg comprime pellicule 00242/0302 Topamax 50mg tabsSE/H/0110/003 France 342 645.5 Epitomax 100mg comprime pellicule 00242/0303 Topamax 100mg tabsDE/H/6157/001 France 343 840.6 Xalatan 0,005 pour cent, collyre en solution 00057/1057 Xalatan eye dropsDE/H/6157/001 France 343 841.2 Xalatan 0,005 pour cent, collyre en solution 00057/1057 Xalatan eye dropsDE/H/0899/004 France 347 591.0 Neurontin 600mg 50622/0049 Neurontin 600mg tabsNL/H/0144/002 France 347 935.1 Maxalt 10mg 00025/0370 Maxalt 10mg tabsDK/H/0168/002 France 353 572.4 Trileptal 300mg comprime 00101/0582 Trileptal 300mg tabsSE/H/0211/001 France 355 334.3 INexium 20mg comprimes gastro-resistants 17901/0068 Nexium 20mg tabsSE/H/0110/002 France 356 341.3 Epitomax 50mg comprime pellicule 00242/0302 Topamax 50mg tabsSE/H/0110/003 France 356 344.2 Epitomax 100mg comprime pellicule 00242/0303 Topamax 100mg tabsSE/H/0249/001 France 357 602.5 Xalacom 50 microgrammes/ml + 5 mg/ml, collyre en solution 00057/1056 Xalacom eye dropsSE/H/0249/001 France 357 603.1 Xalacom 50 microgrammes/ml + 5 mg/ml, collyre en solution 00057/1056 Xalacom eye dropsNL/H/4583/002 France 357 868.5 Relpax 40mg 50622/0054 Relpax 40mg tabsSE/H/0278/004 France 359 941.1 Seroplex 20mg 13761/0011 Cipralex 20mg tabsSE/H/0304/001 France 361 825.5 Avodart 0.5mg capsule molle 19494/0006 Avodart 0.5mg soft capsNL/H/0487/001 France 365 515.0 Vesicare 5mg, comprime pellicule 00166/0197 Vesicare 5mg tabsNL/H/0343/004 France 369 853.8 Crestor 5mg 17901/0243 Crestor 5mg tabsAT/H/0983/004 France 373 064.4 Aricept 10mg Comprimes Orodispersibles 10555/0020 Aricept Evess 10mg orodispersible tabsPT/H/2299/001 France 387 925.7 Arcoxia 60 mg comprime pellicule 00025/0642 Arcoxia 60mg tabsPT/H/2299/004 France 387 980.8 Arcoxia 30 mg comprime pellicule 00025/0641 Arcoxia 30mg tabsDK/H/1405/001 France 389 697.1 Xamiol 50 microgrammes/0,5 mg/g gel 05293/0006 Xamiol gelIE/H/0716/003 Germany 16465.00.00 Zinnat 125mg filmtabletten 10949/0095 Zinnat 125mg tabsIE/H/0716/001 Germany 16465.00.01 Zinnat Trockensaft 10949/0094 Zinnat 125mg/5ml suspension

Version: 11/11/2020 Page: 18 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductIE/H/0716/004 Germany 16465.01.00 Zinnat 250mg filmtabletten 10949/0096 Zinnat 250mg tabsIE/H/0716/005 Germany 16465.02.00 Zinnat 500mg filmtabletten 10949/0119 Zinnat 500mg tabsNL/H/3915/002 Germany 18411.00.00 Durogesic SMAT 25 Mikrogramm/Stunde Transdermales Pflaster 00242/0192 Durogesic DTrans 25ug/hrNL/H/3915/003 Germany 18411.01.00 Durogesic SMAT 50 Mikrogramm/Stunde Transdermales Pflaster 00242/0193 Durogesic DTrans 50ug/hrNL/H/3915/004 Germany 18411.02.00 Durogesic SMAT 75 Mikrogramm/Stunde Transdermales Pflaster 00242/0194 Durogesic DTrans 75ug/hrNL/H/3915/005 Germany 18411.03.00 Durogesic SMAT 100 Mikrogramm/Stunde Transdermales Pflaster 00242/0195 Durogesic DTrans 100ug/hrDE/H/2184/009 Germany 28754.00.00 Risperdal Quicklet 1mg Schmelztabletten 00242/0379 Risperdal Quicklet 1mg tabsDE/H/2184/010 Germany 28754.01.00 Risperdal Quicklet 2mg Schmelztabletten 00242/0380 Risperdal Quicklet 2mg tabsDE/H/0363/006 Germany 2881.01.01 Salofalk 500mg, magensaftresistente Tabletten 08637/0019 Salofalk 500mg tabsDE/H/0116/001 Germany 29689.00.00 Locol 20mg Hartkapsel 00101/0360 Lescol 20mg capsDE/H/0116/002 Germany 29689.01.00 Locol 40 mg Hartkapseln 00101/0361 Lescol 40mg capsNL/H/1539/002 Germany 33122.00.00 Lamictal 5mg Tabletten zur Herstellung einer Suspension zum Einnehmen bzw. Kautab00003/0346 Lamictal 5mg dispersible tabsNL/H/1539/003 Germany 33122.01.00 Lamictal 25mg Tabletten zur Herstellung einer Suspension zum Einnehmen bzw. Kauta00003/0347 Lamictal 25mg dispersible tabsNL/H/1539/004 Germany 33122.02.00 Lamictal 50mg Tabletten zur Herstellung einer Suspension zum Einnehmen bzw. Kauta00003/0368 Lamictal 50mg dispersible tabsNL/H/1539/005 Germany 33122.03.00 Lamictal 100mg Tabletten zur Herstellung einer Suspension zum Einnehmen bzw. Kau00003/0348 Lamictal 100mg dispersible tabsDE/H/2184/008 Germany 35950.00.00 Risperdal Losung 1mg/ml, Losung zum Einnehmen 00242/0199 Risperdal 1mg/ml oral solnNL/H/1458/001 Germany 36017.00.00 Lorzaar Plus 50/12.5mg filmtabletten 00025/0338 Cozaar Comp 50mg/12.5mgIE/H/0838/001 Germany 39682.00.00 Sempera Liquid 10mg/ml, Lösung zum Einnehmen 00242/0307 Sporanox LiquidSE/H/0121/001 Germany 39806.00.00 Oxis Turbohaler 6 mikrogramm pulver sur inhalation 17901/0154 Oxis Turbohaler 6NL/H/2081/008 Germany 39993.00.00 Antra MUPS 20 mg magensaftresistente Tabletten 17901/0138 Losec MUPS 20mg tabsDE/H/6220/001 Germany 40274.00.00 Malarone Filmtabletten 10949/0258 Malarone tabsNL/H/2081/006 Germany 40292.02.00 Antra MUPS 10mg magensaftresistente Tabletten 17901/0137 Losec MUPS 10mg tabsDE/H/6157/001 Germany 40466.00.00 Xalatan 0,005 % Augentropfen 00057/1057 Xalatan eye dropsSE/H/0565/001 Germany 40763.00.00 CoDiovan 80 mg/12,5 mg Filmtabletten 00101/0480 Co-Diovan 80/12.5mg tabsSE/H/1821/001 Germany 40803.00.00 Nasonex 50µg / Sprühstoß Nasenspray, Suspension 00025/0587 Nasonex 50ug/actuation nasal sprayNL/H/1457/001 Germany 41542.00.00 Lorzaar Start 12.5mg filmtabletten 00025/0515 Cozaar 12.5mg tabsNL/H/1457/002 Germany 41546.01.00 Lorzaar Protect 50mg filmtabletten 00025/0324 Cozaar 50mg tabsNL/H/1457/003 Germany 41546.02.00 Lorzaar Protect 100mg filmtabletten 00025/0416 Cozaar 100mg tabsDE/H/4690/002 Germany 42640.01.00 Delmuno 5mg/5mg retardtablette 04425/0320 Triapin 5mg/5mg PR tabsSE/H/0147/001 Germany 43299.00.00 Cerazette 75 mikrogramm filmtabletten 00025/0562 Cerazette 75mcg tabsNL/H/0144/001 Germany 43363.00.00 Maxalt 5mg Tabletten 00025/0369 Maxalt 5mg tabsNL/H/0144/002 Germany 43363.01.00 Maxalt 10mg Tabletten 00025/0370 Maxalt 10mg tabsNL/H/0144/004 Germany 43365.01.00 Maxalt lingua 10mg schmelztabletten 00025/0372 Maxalt Melt 10mgDE/H/2184/002 Germany 43776.01.00 Risperdal filmtabletten 0.5mg 00242/0347 Risperdal 0.5mg tabsSE/H/1826/002 Germany 44258.00.00 Pariet 10mg 10555/0010 Pariet 10mg tabsSE/H/1826/001 Germany 44258.01.00 Pariet 20mg magensaftresistente tabletten 10555/0008 Pariet 20mg tabsDE/H/5916/001 Germany 44412.00.00 Isotrexin Gel 19494/0068 Isotrexin GelNL/H/0150/001 Germany 44868.00.00 Implanon NXT 00025/0563 NexplanonSE/H/0169/001 Germany 44915.00.00 Atmadisc Mite 50ug/100ug Diskus 10949/0314 Seretide 100 AccuhalerSE/H/0169/002 Germany 44915.01.00 Atmadisc 50ug/250ug Diskus 10949/0315 Seretide 250 AccuhalerSE/H/0169/003 Germany 44915.02.00 Atmadisc Forte 50ug/500ug Diskus 10949/0316 Seretide 500 AccuhalerDE/H/0235/001 Germany 45088.00.00 Lipidil-Ter 160mg 46302/0024 Supralip 160mg tabsNL/H/0156/001 Germany 47291.00.00 Seroquel 25mg filmtabletten 50827/0002 Seroquel 25mg tabsNL/H/0156/002 Germany 47291.01.00 Seroquel 100mg filmtabletten 50827/0003 Seroquel 100mg tabsNL/H/0156/003 Germany 47291.02.00 Seroquel 200mg filmtabletten 50827/0004 Seroquel 200mg tabsNL/H/0156/007 Germany 47291.04.00 Seroquel 300mg filmtabletten 50827/0005 Seroquel 300mg tabsDK/H/0168/002 Germany 47357.01.00 Trileptal 300mg filmtabletten 00101/0582 Trileptal 300mg tabsDK/H/0168/003 Germany 47357.02.00 Trileptal 600mg filmtabletten 00101/0583 Trileptal 600mg tabs

Version: 11/11/2020 Page: 19 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductNL/H/4790/001 Germany 48835.00.00 Corifeo 10mg filmtabletten 04595/0005 Zanidip 10mg tabsNL/H/4790/002 Germany 48835.01.00 Corifeo 20mg filmtabletten 04595/0010 Zanidip 20mg tabsSE/H/0211/001 Germany 49509.00.00 Nexium mups 20mg magensaftresistente Tabletten 17901/0068 Nexium 20mg tabsSE/H/0211/002 Germany 49509.01.00 Nexium mups 40mg magensaftresistente Tabletten 17901/0069 Nexium 40mg tabsDE/H/0299/001 Germany 49903.00.00 Xusal 5mg Filmtabletten 00039/0539 Xyzal 5mg tabsSE/H/0225/001 Germany 50256.00.00 Zaditen ophtha 0,25 mg/ml Augentropfen 20162/0019 Zaditen 0.25mg/ml eye dropsSE/H/0406/003 Germany 50477.00.00 Diovan 80mg filmtabletten 00101/0600 Diovan 80mg tabsSE/H/0406/004 Germany 50477.01.00 Diovan 160mg protect filmtabletten 00101/0601 Diovan 160mg tabsSE/H/0406/005 Germany 50477.02.00 Diovan 40mg filmtabletten 00101/0599 Diovan 40mg tabsDE/H/5770/002 Germany 50678.01.00 Atmadisc Dosier-Aerosol 25ug/125ug Druckgasinhalation, Suspension 10949/0338 Seretide 125 EvohalerDE/H/5770/003 Germany 50678.02.00 Atmadisc forte Dosier-Aerosol 25ug/250ug Druckgasinhalation, Suspension 10949/0339 Seretide 250 EvohalerDE/H/5771/002 Germany 50681.01.00 Viani Dosier-Aerosol 25ug/125ug Druckgasinhalation, Suspension 10949/0342 Viani 125 EvohalerDE/H/5771/003 Germany 50681.02.00 Viani Dosier-Aerosol 25ug/250ug Druckgasinhalation, Suspension 10949/0343 Viani 250 EvohalerSE/H/0230/001 Germany 50703.00.00 Symbicort Turbohaler 80/4,5 Mikrogramm/Dosis Pulver zur Inhalation 17901/0091 Symbicort 100/6 TurbohalerSE/H/0229/001 Germany 50703.01.00 Symbicort Turbohaler 160/4,5 Mikrogramm/Dosis Pulver zur Inhalation 17901/0092 Symbicort 200/6 TurbohalerSE/H/0229/002 Germany 50703.02.00 Symbicort Turbohaler 320/9 Mikrogramm/Dosis Pulver zur Inhalation 17901/0200 Symbicort 400/12 TurbohalerNL/H/1458/003 Germany 50798.00.00 Fortzaar 100mg/25mg filmtabletten 00025/0374 Cozaar Comp 100mg/25mgFR/H/0178/001 Germany 51085.00.00 Fem7 Sequi 50 Mikrogramm + 50 Mikrogramm/10 Mikrogramm/24 Stunden Transderm49876/0011 FemSeven Sequi patchesDE/H/5646/001 Germany 51310.00.00 Caverject Impuls 10 µg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung00057/0939 Caverject DCS 10ugDE/H/5646/002 Germany 51310.01.00 Caverject Impuls 20 µg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung00057/0940 Caverject DCS 20ugSE/H/0249/001 Germany 51710.00.00 Xalacom 50 Mikrogramm Latanoprost + 5 mg Timolol pro ml Augentropfen, Lösung 00057/1056 Xalacom eye dropsSE/H/1421/001 Germany 51816.00.00 Estradot 37,5 mikrogramm/24 Stunden transdermales Pflaster 00101/0642 Estradot 37.5ug/24hSE/H/1421/002 Germany 51816.01.00 Estradot 50 mikrogramm/24 Stunden transdermales Pflaster 00101/0643 Estradot 50ug/24hSE/H/1421/005 Germany 51816.04.00 Estradot 25 mikrogramm/24 Stunden transdermales Pflaster 00101/0703 Estradot 25ug/24hNL/H/0299/001 Germany 52523.00.00 Spiriva 18 Mikrogramm Kapsel mit Inhalationspulver 14598/0062 Spiriva 18mcg inhalation powderNL/H/0718/001 Germany 52523.00.01 Spiriva Respimat 2,5 Mikrogramm Lösung zur Inhalation 14598/0084 Spiriva RespimatDE/H/6100/001 Germany 52662.00.00 Salbulair N 100 Mikrogramm Easi-Breathe Druckgasinhalation, Suspension 00530/0556 Salamol Easi-Breathe InhalerSE/H/0565/002 Germany 52884.00.00 CoDiovan 160 mg / 12,5 mg Filmtabletten 00101/0650 Co-Diovan 160/12.5mg tabsSE/H/0565/003 Germany 52884.01.00 CoDiovan forte 160 mg / 25 mg Filmtabletten 00101/0651 Co-Diovan 160/25mg tabsDE/H/0769/002 Germany 5382.01.00 Capozide 50 tabletten 00034/0263 Capozide tabsDE/H/0690/001 Germany 54569.00.00 Medikinet 5mg Tabletten 11243/0002 Medikinet 5mg tabsDE/H/0690/004 Germany 54569.00.01 Medikinet retard 10mg Hartkapseln mit veranderter Wirkstofffreisetzung 11243/0005 Medikinet XL 10mg capsDE/H/0690/003 Germany 54569.01.00 Medikinet 5mg Tabletten 11243/0004 Medikinet 20mg tabsDE/H/0690/005 Germany 54569.01.01 Medikinet retard 20mg Hartkapseln mit veranderter Wirkstofffreisetzung 11243/0006 Medikinet XL 20mg capsDE/H/6007/001 Germany 54861.00.00 Concerta 18mg retardtabletten 00242/0372 Concerta XL 18mg tabsDE/H/6007/002 Germany 54861.01.00 Concerta 36mg retardtabletten 00242/0373 Concerta XL 36mg tabsDE/H/6007/003 Germany 54861.02.00 Concerta 54mg retardtabletten 00242/0374 Concerta XL 54mg tabsSE/H/0278/002 Germany 55880.01.00 Cipralex 10mg filmtabletten 13761/0009 Cipralex 10mg tabsFR/H/0228/001 Germany 56645.00.00 Duraphat Fluorid 5mg/g Zahnpaste 00049/0050 Duraphat 5000ppm fluoride toothpasteFR/H/0685/001 Germany 58361.00.00 Fem7 Conti 50 mikrogramm/7Mikrogramm/24 Stunden Trasndermales Pflaster 49876/0010 FemSeven Conti patchesNL/H/0487/001 Germany 59808.00.00 Vesikur 5mg filmtabletten 00166/0197 Vesicare 5mg tabsNL/H/0487/002 Germany 59808.01.00 Vesikur 10mg filmtabletten 00166/0198 Vesicare 10mg tabsFI/H/0313/001 Germany 60074.00.00 Nebido 1000mg Injektionslösung 00010/0549 Nebido 1000mg/4ml injNL/H/3915/001 Germany 60415.00.00 Durogesic SMAT 12 Mikrogramm/Stunde Transdermales Pflaster 00242/0409 Durogesic DTrans 12ug/hrDK/H/0718/001 Germany 62138.00.00 Norspan 5 Mikrogramm/h Transdermales Pflaster 16950/0136 BuTrans 5mcg/h patchDK/H/0718/002 Germany 62139.00.00 Norspan 10 Mikrogramm/h Transdermales Pflaster 16950/0137 BuTrans 10mcg/h patchDK/H/0718/003 Germany 62140.00.00 Norspan 20 Mikrogramm/h Transdermales Pflaster 16950/0138 BuTrans 20mcg/h patchDE/H/0690/006 Germany 62567.00.00 Medikinet retard 30mg Hartkapseln mit veranderter Wirkstofffreisetzung 11243/0007 Medikinet XL 30mg caps

Version: 11/11/2020 Page: 20 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductDE/H/0690/007 Germany 62568.00.00 Medikinet retard 40mg Hartkapseln mit veranderter Wirkstofffreisetzung 11243/0008 Medikinet XL 40mg capsFI/H/0981/001 Germany 62856.00.00 Tobradex 3 mg/ml / 1 mg/ml Augentropfensuspension 00101/1007 Tobradex eye dropsFR/H/0070/002 Germany 63083.00.00 Trusopt-S 20 mg/ml Augentropfen im Einzeldosisbehaltnis 16058/0013 Trusopt SDUFR/H/0272/001 Germany 63147.00.00 Tramadolor einmal täglich 100mg Retardtabletten 43808/0001 Tradorec XL 100mg tabsFR/H/0272/002 Germany 63148.00.00 Tramadolor einmal täglich 200mg Retardtabletten 43808/0002 Tradorec XL 200mg tabsFR/H/0272/003 Germany 63149.00.00 Tramadolor einmal täglich 300mg Retardtabletten 43808/0003 Tradorec XL 300mg tabs

AT/H/0983/003 Germany 63987.00.00 Aricept Evess 5mg Schmelztabletten 10555/0019 Aricept Evess 5mg oprodispersible tabsAT/H/0983/004 Germany 63988.00.00 Aricept Evess 10mg Schmelztabletten 10555/0020 Aricept Evess 10mg orodispersible tabsDK/H/2888/001 Germany 64003.00.00 Equasym Retard 10mg 27303/0004 Equasym XL 10mg capsDK/H/2888/002 Germany 64004.00.00 Equasym Retard 20mg 27303/0005 Equasym XL 20mg capsDK/H/2888/003 Germany 64005.00.00 Equasym Retard 30mg 27303/0006 Equasym XL 30mg capsDE/H/0871/001 Germany 64260.00.00 Kantos 100/6 Mikrogramm Druckgasinhalation 08829/0156 Fostair 100/6 inhalerNL/H/0732/001 Germany 64753.00.00 Mezavant 1200mg magensaftresistente Retardtababletten 08081/0040 Mezavant XL 1200mg tabsNL/H/1458/002 Germany 64982.00.00 Lorzaar Plus Forte 100/12.5mg filmtabletten 00025/0473 Cozaar Comp 100mg/12.5mgSE/H/1984/001 Germany 65881.00.00 Oraycea 40 mg Hartkapseln mit veränderter Wirkstofffreisetzung 10590/0056 Efracea 40mg capsDE/H/0690/002 Germany 6620412.00.00 Medikinet 10mg Tabletten 11243/0003 Medikinet 10mg tabsDE/H/0690/008 Germany 66625.00.00 Medikinet retard 5mg Hartkapseln mit veradnerter Wirkstofffreisetzung 11243/0010 Medikinet XL 5mg capsDE/H/0844/003 Germany 67042.00.00 Lodotra 5mg Tabletten mit veranderter 16950/0175 Lodotra 5mg tabsSE/H/0406/006 Germany 67298.00.00 Diovan 320mg forte filmtabletten 00101/0726 Diovan 320mg tabsDE/H/0844/001 Germany 67400.00.00 Lodotra 1mg Tabletten mit veranderter 16950/0173 Lodotra 1mg tabsDE/H/0844/002 Germany 67401.00.00 Lodotra 2mg Tabletten mit veranderter 16950/0174 Lodotra 2mg tabsDE/H/5733/001 Germany 69088.00.00 Versatis 700mg wirkstoffhaltiges Pflaster 21727/0016 Versatis 700mg medicated plasterNL/H/1113/001 Germany 70001.00.00 Sevikar 20mg/5mg Filmtabletten 08265/0026 Sevikar 20mg/5mg tabsNL/H/1113/002 Germany 70002.00.00 Sevikar 40mg/5mg Filmtabletten 08265/0027 Sevikar 40mg/5mg tabsNL/H/1113/003 Germany 70003.00.00 Sevikar 40mg/10mg Filmtabletten 08265/0028 Sevikar 40mg/10mg tabsDE/H/0221/002 Germany 70133.00.00 uriVesc 60mg retardkapseln 46302/0194 Regurin XL 60mg capsNL/H/0156/008 Germany 70561.00.00 Seroquel prolong 50mg retardtabletten 50827/0006 Seroquel XL 50mg tabsNL/H/0156/009 Germany 70562.00.00 Seroquel prolong 200mg retardtabletten 50827/0008 Seroquel XL 200mg tabsNL/H/0156/010 Germany 70563.00.00 Seroquel prolong 300mg retardtabletten 50827/0009 Seroquel XL 300mg tabsNL/H/0156/011 Germany 70564.00.00 Seroquel prolong 400mg retardtabletten 50827/0010 Seroquel XL 400mg tabsDK/H/3038/001 Germany 70915.00.00 Naratriptan-ratiopharm 2,5 mg Filmtabletten 00289/1106 Naratriptan 2.5mg tabsDE/H/6007/004 Germany 72263.00.00 Concerta 27mg retardtabletten 00242/0400 Concerta XL 27mg tabsNL/H/0156/012 Germany 73290.00.00 Seroquel prolong 150mg retardtabletten 50827/0007 Seroquel XL 150mg tabsDE/H/1913/001 Germany 75064.00.00 Lercanidipin-HCl Teva 10mg filmtabletten 00289/1283 Lercanidipine hydrochloride 10mg tabsDE/H/1913/002 Germany 75065.00.00 Lercanidipin-HCl Teva 20mg filmtabletten 00289/1284 Lercanidipine hydrochloride 20mg tabsDE/H/2251/001 Germany 76877.00.00 Duodart 0.5mg/0.4mg Hartkapseln 19494/0046 Combodart 0.5mg/0.4mg capsCZ/H/0100/002 Germany 77613.00.00 Losartan-Kalium TAD 12.5mg filmtabletten 01656/0070 Losartan potassium 12.5mg tabsDK/H/2871/001 Germany 79572.00.00 Picoprep 03194/0014 PicolaxSE/H/0908/001 Germany 80540.00.00 Jext 150 mikrogramm injektionslosung in einem Fertigpen 10085/0052 Jext 150mcg PenSE/H/0908/002 Germany 80541.00.00 Jext 300 mikrogramm injektionslosung in einem Fertigpen 10085/0053 Jext 300mcg PenNL/H/3926/001 Germany 81465.00.00 Fusidinsäure Basic Pharma 20 mg/g Creme 20046/0256 Fusidic acid Focus 20mg/g creamSE/H/1921/002 Germany 81898.00.00 Flutiform 125 Mikrogramm/5 Mikrogramm pro Spruhstoβ 16950/0168 Flutiform 125mcg/5mcg inhalerDE/H/2915/001 Germany 82525.00.00 Latanoprost Pfizer 50 Mikrogramm/ml Augentropfen 00057/1221 Latanoprost Pfizer 50ug/ml eye dropsIE/H/1015/001 Germany 82765.00.00 GabaLiquid GeriaSan 50mg/ml losung zum einnehmen 00427/0155 Gabapentin Rosemont 50mg/ml oral solnDE/H/3012/001 Germany 83357.00.00 Levothyroxin-ratiopharm 25 Mikrogramm/5 ml Lösung zum Einnehmen 00289/1593 Levothyroxine 25mcg/5ml oral solnDE/H/5930/001 Germany 83425.00.00 Phenytoin sodium Aurobindo 100mg Filmtabletten 16363/0279 Phenytoin sodium Milpharm 100mg tabsAT/H/0318/001 Germany 83967.00.00 Esomeprazole dura 20mg 04569/1268 Esomeprazole 20mg capsAT/H/0318/002 Germany 83968.00.00 Esomeprazole dura 40mg 04569/1269 Esomeprazole 40mg caps

Version: 11/11/2020 Page: 21 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductSE/H/1074/001 Germany 84671.00.00 Latanoprost/Timolol Pfizer 50 Mikrogramm/ml + 5 mg/ml Augentropfen 00057/1322 Latanoprost/Timolol Pfizer 50+5 ug/mlDE/H/0871/002 Germany 85306.00.00 Kantos Nexthaler 100 Mikrogramm / 6 Mikrogramm pro Dosis Pulver zur Inhalation 08829/0173 Fostair Nexthaler 100/6SE/H/0643/002 Germany 88083.00.00 Metex Pen 7.5mg Injektionslösung im Fertigpen 11587/0076 Metoject Pen 7.5mgSE/H/0643/003 Germany 88084.00.00 Metex Pen 10mg Injektionslösung im Fertigpen 11587/0077 Metoject Pen 10mgSE/H/0643/004 Germany 88085.00.00 Metex Pen 12.5mg Injektionslösung im Fertigpen 11587/0078 Metoject Pen 12.5mgSE/H/0643/005 Germany 88086.00.00 Metex Pen 15mg Injektionslösung im Fertigpen 11587/0079 Metoject Pen 15mgSE/H/0643/006 Germany 88087.00.00 Metex Pen 17.5mg Injektionslösung im Fertigpen 11587/0080 Metoject Pen 17.5mgSE/H/0643/007 Germany 88088.00.00 Metex Pen 20mg Injektionslösung im Fertigpen 11587/0081 Metoject Pen 20mgSE/H/0643/008 Germany 88089.00.00 Metex Pen 22.5mg Injektionslösung im Fertigpen 11587/0082 Metoject Pen 22.5mgSE/H/0643/009 Germany 88090.00.00 Metex Pen 25mg Injektionslösung im Fertigpen 11587/0083 Metoject Pen 25mgSE/H/0643/010 Germany 88091.00.00 Metex Pen 27.5mg Injektionslösung im Fertigpen 11587/0084 Metoject Pen 27.5mgSE/H/0643/011 Germany 88092.00.00 Metex Pen 30mg Injektionslösung im Fertigpen 11587/0085 Metoject Pen 30mgDK/H/2028/001 Germany 88326.00.00 Methylphenidathydrochlorid - 1 A Pharma 18mg Retardtabletten 04416/1346 Matoride XL 18mg tabsDK/H/2028/002 Germany 88327.00.00 Methylphenidathydrochlorid - 1 A Pharma 36mg Retardtabletten 04416/1348 Matoride XL 36mg tabsDK/H/2028/003 Germany 88328.00.00 Methylphenidathydrochlorid - 1 A Pharma 54mg Retardtabletten 04416/1349 Matoride XL 54mg tabsDE/H/0690/009 Germany 88767.00.00 Medikinet retard 50mg Hartkapseln mit veranderter Wirkstofffreisetzung 11243/0011 Medikinet XL 50mg capsDE/H/0690/010 Germany 88768.00.00 Medikinet retard 60mg Hartkapseln mit veranderter Wirkstofffreisetzung 11243/0012 Medikinet XL 60mg capsDE/H/5724/002 Germany 91144.00.00 Serkep 25 Mikrogramm/250 Mikrogramm pro Sprühstoß Druckgasinhalation 04569/1450 Sirdupla 25/250mcg inhalerNL/H/3157/001 Germany 92213.00.00 Spiolto respimat 2,5 mikrogramm/2,5 mikrogramm pro hub losung zur inhalation 14598/0101 Spiolto RespimatSE/H/1428/001 Germany 92429.00.00 Soolantra 10mg/g creme 10949/0063 Soolantra 10mg/g creamSE/H/1839/006 Germany 93473.00.00 Elvanse 60mg hartkapseln 08081/0064 Elvanse 60mg capsAT/H/0609/001 Germany 94696.00.00 Naproxen InfectoPharm 50mg/ml Suspension 15011/0020 Naproxen 50mg/ml oral suspDK/H/0134/003 Germany 99981.00.00 Cosopt sine 20mg/ml + 5mg/ml Augentropfen, Lösung 16058/0025 Cosopt iMultiDK/H/0134/003 Greece 2413703 Cosopt iMulti 20mg/ml + 5mg/ml, οφθαλμικές σταγόνες, διάλυμα 16058/0025 Cosopt iMultiDK/H/0168/003 Greece 101059/17/26-10-2018 Trileptal 600mg 00101/0583 Trileptal 600mg tabsDE/H/0299/001 Greece 10273/12-02-2007 Xozal 5mg επικαλυμμένα με λεπτό υμένιο δισκία 00039/0539 Xyzal 5mg tabsFR/H/0070/001 Greece 108326/14/15-01-2015 Trusopt 20 mg/ml 16058/0014 Trusopt Eye DropsDK/H/0134/001 Greece 108327/14/15-01-2015 COSOPT, eye drops, solution (2+0,5)% w/v 16058/0016 Cosopt solutionSE/H/0110/007 Greece 10937/21.3.02 Topamac 15 mg καψάκια σκληρά 00242/0348 Topamax Sprinkle 15mg capsSE/H/0110/009 Greece 10939/21.3.02 Topamac 50 mg καψάκια σκληρά 00242/0350 Topamax Sprinkle 50mg capsDK/H/0134/001 Greece 110211/09-11-2018 COSOPT, eye drops, solution (2+0,5)% w/v 16058/0016 Cosopt solutionNL/H/2160/001 Greece 11266/30-7-2001 Primaxin IV 500mg 00025/0229 Primaxin 500mgNL/H/1540/003 Greece 11382/16-02-2015 Lamictal 100mg tablets 00003/0274 Lamictal 100mg tabsNL/H/1540/004 Greece 11384/16-02-2015 Lamictal 200mg tablets 00003/0297 Lamictal 200mg tabsDK/H/0168/004 Greece 115953/17/26-10-2018 Trileptal 60mg/ml Πόσιμο Εναιώρημα 00101/0631 Trileptal 60mg/ml suspensionNL/H/0154/001 Greece 11620/21-2-2008 Silkis ΑΛΟΙΦΗ 10590/0047 Silkis ointmentSE/H/0210/005 Greece 11761/22/2/2005 Reminyl 8mg καψάκια παρατεταμένης αποδέσμευσης, σκληρά 08557/0052 Reminyl XL 8mg capsSE/H/0210/006 Greece 11762/22-02-2005 Reminyl 16mg καψάκια παρατεταμένης αποδέσμευσης, σκληρά 08557/0053 Reminyl XL 16mg capsSE/H/0210/007 Greece 11763/22-02-2005 Reminyl 24mg καψάκια παρατεταμένης αποδέσμευσης, σκληρά 08557/0054 Reminyl XL 24mg capsSE/H/0210/004 Greece 11967/6-11-2000 Reminyl 4mg/ml πόσιμο διάλυμα 08557/0042 Reminyl 4mg/ml solnSE/H/1861/002 Greece 12004/12-02-2013 Alvesco pressurised inhalation, solution 160 mcg/dose 17901/0298 Alvesco 160 inhalerDE/H/6007/001 Greece 12582/19.02.2015 Concerta 18mg δισκία παρατεταμένης αποδέσμευσης 00242/0372 Concerta XL 18mg tabsDE/H/6007/002 Greece 12583/19.02.2015 Concerta 36mg δισκία παρατεταμένης αποδέσμευσης 00242/0373 Concerta XL 36mg tabsDE/H/6157/001 Greece 1338/15.1.2002 Xalatan 0,005% οφθαλμικές σταγόνες, διάλυμα 00057/1057 Xalatan eye dropsDK/H/0279/002 Greece 14651/23-02-2009 Dοvobet 50 micrograms/0.5 mg/g γέλη 05293/0005 Dovobet gelDK/H/1405/001 Greece 14657/23-2-2009 Xamiol 50 microgram/0.5mg/g gel 05293/0006 Xamiol gelFR/H/0649/001 Greece 14789/11/14-02-2013 Amoxil 500mg/cap 00038/0105 Amoxil 500mg caps

Version: 11/11/2020 Page: 22 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductSE/H/0304/001 Greece 15084/24-02-2009 Avodart 0.5mg 19494/0006 Avodart 0.5mg soft capsSE/H/0249/001 Greece 15148/07/4-2-2008 Xalacom 50 mcg/ml + 5mg/ml 00057/1056 Xalacom eye dropsSE/H/0198/002 Greece 15875/9/3/2006 Celebrex Καψάκιο, σκληρό 200 mg 50622/0012 Celebrex 200mg capsFI/H/0139/001 Greece 18561/18.11.93 Sabril 500mg tablets 04425/0171 Sabril 500mg tabsDE/H/2020/004 Greece 19219/15.3.2011 Palexia retard 50mg δισκία παρατεταμένης αποδέσμευσης 21727/0041 Palexia SR 50mg tabsDE/H/2020/005 Greece 19220/15.3.2011 Palexia retard 100mg δισκία παρατεταμένης αποδέσμευσης 21727/0042 Palexia SR 100mg tabsDE/H/2020/006 Greece 19221/15.3.2011 Palexia retard 150mg δισκία παρατεταμένης αποδέσμευσης 21727/0043 Palexia SR 150mg tabsDE/H/2020/007 Greece 19222/15.3.2011 Palexia retard 200mg δισκία παρατεταμένης αποδέσμευσης 21727/0044 Palexia SR 200mg tabsDE/H/2020/008 Greece 19223/15.3.2011 Palexia retard 250mg δισκία παρατεταμένης αποδέσμευσης 21727/0045 Palexia SR 250mg tabsDK/H/0168/003 Greece 19773/04/31.3.2005 Trileptal 600mg 00101/0583 Trileptal 600mg tabsDK/H/0168/002 Greece 19775/04/31-3-2005 Trileptal 300mg 00101/0582 Trileptal 300mg tabsDE/H/0991/002 Greece 19792/16-03-2011 Saflutan eye drop solution for single dose 15ug/ml 16058/0017 Saflutan 15ug/ml eye dropsNL/H/0156/001 Greece 19858/30.03.2005 Seroquel 25mg επικαλυμμένα με λεπτό υμένιο δισκία 50827/0002 Seroquel 25mg tabsNL/H/0156/002 Greece 19859/30.03.2005 Seroquel 100mg επικαλυμμένα με λεπτό υμένιο δισκία 50827/0003 Seroquel 100mg tabsNL/H/0156/003 Greece 19860/30.03.2005 Seroquel 200mg επικαλυμμένα με λεπτό υμένιο δισκία 50827/0004 Seroquel 200mg tabsNL/H/0156/007 Greece 19866/30.03.2005 Seroquel 300mg επικαλυμμένα με λεπτό υμένιο δισκία 50827/0005 Seroquel 300mg tabsDE/H/0523/001 Greece 20162/27-3-2006 Οlmetec 20mg/12,5mg επικαλυμμένο με λεπτό υμένιο δισκίο 08265/0022 Olmetec Plus 20mg/12.5mg tabsDE/H/0523/002 Greece 20163/27-3-2006 Οlmetec 20mg/25mg επικαλυμμένο με λεπτό υμένιο δισκίο 08265/0023 Olmetec Plus 20mg/25mg tabsPT/H/2256/001 Greece 20795/26-03-07 Nasacort 55mcg/dose 04425/0287 Nasacort 55mcg/dose nasal sprayDE/H/0871/004 Greece 23848/3-4-2017 Foster Nexthaler Inhalation Powder (200+6)mcg/dose 08829/0174 Fostair Nexthaler 200/6IE/H/0574/001 Greece 23937/03-04-2105 Rectogesic 4mg/g 16508/0037 Rectogesic ointmentDE/H/0899/002 Greece 26441/9-4-2009 Neurontin 300mg 50622/0047 Neurontin 300mg capsDE/H/0899/003 Greece 26442/9-4-2009 Neurontin 400mg 00057/0537 Neurontin 400mg capsDK/H/0134/002 Greece 26603/20-4-2007 Cosopt PF (20+5) mg/1ml 16058/0015 Cosopt SDUDK/H/0168/002 Greece 27842/99/4.2.2000 Trileptal 300mg 00101/0582 Trileptal 300mg tabsDK/H/0168/003 Greece 27843/99/4.2.2000 Trileptal 600mg 00101/0583 Trileptal 600mg tabsDE/H/5770/001 Greece 28386/11-5-2011 Seretide 25/50mcg inhaler 10949/0337 Seretide 50 EvohalerDE/H/5770/002 Greece 28387/11-5-2011 Seretide 25/125mcg inhaler 10949/0338 Seretide 125 EvohalerDE/H/5770/003 Greece 28388/11-5-2011 Seretide 25/250mcg inhaler 10949/0339 Seretide 250 EvohalerSE/H/0249/001 Greece 28614/23-4-2012 Xalacom 50 mcg/ml + 5mg/ml 00057/1056 Xalacom eye dropsDE/H/0496/003 Greece 29541/20-4-2011 Inegy Δισκία 10mg/40mg 00025/0611 Inegy 10mg/40mg tabsNL/H/1230/001 Greece 29622/29-4-2009 Qlaira 00010/0576 Qlaira tabsIT/H/0774/001 Greece 29751/10.05.2006 Lyrinel 5mg 00242/0385 Lyrinel XL 5mg tabsIT/H/0744/002 Greece 29752/10.05.2006 Lyrinel 10mg 00242/0386 Lyrinel XL 10mg tabsSE/H/0210/004 Greece 29840/08.05.2008 Reminyl 4mg/ml πόσιμο διάλυμα 08557/0042 Reminyl 4mg/ml solnSE/H/0210/005 Greece 29841/08-05-2008 Reminyl 8mg καψάκια παρατεταμένης αποδέσμευσης, σκληρά 08557/0052 Reminyl XL 8mg capsSE/H/0210/006 Greece 29842/08-05-2008 Reminyl 16mg καψάκια παρατεταμένης αποδέσμευσης, σκληρά 08557/0053 Reminyl XL 16mg capsSE/H/0210/007 Greece 29843/08.05.2008 Reminyl 24mg καψάκια παρατεταμένης αποδέσμευσης, σκληρά 08557/0054 Reminyl XL 24mg capsFR/H/0110/001 Greece 30384/8-10-2001 Femara film-coated tablet 2,5mg 00101/0493 Femara 2.5mg tabsFR/H/0228/001 Greece 30477/07/24-06-2008 Duraphat 5000 toothpaste 500mg/100g 00049/0050 Duraphat 5000ppm fluoride toothpasteSE/H/0527/003 Greece 31330/03.05.2012 Zestril 10mg 17901/0062 Zestril 10mg tabsDE/H/3355/001 Greece 31742/10-06-2014 Dymista Ρινικό Εκνέφωμα 137 μικρογραμμάρια / 50 μικρογραμμάρια ανά ψεκασμό 15142/0258 Dymista Nasal SpraySE/H/0210/004 Greece 31820/12-05-2015 Reminyl 4mg/ml πόσιμο διάλυμα 08557/0042 Reminyl 4mg/ml solnSE/H/0210/005 Greece 31821/12-05-2015 Reminyl 8mg καψάκια παρατεταμένης αποδέσμευσης, σκληρά 08557/0052 Reminyl XL 8mg capsSE/H/0210/006 Greece 31822/12-05-2015 Reminyl 16mg καψάκια παρατεταμένης αποδέσμευσης, σκληρά 08557/0053 Reminyl XL 16mg capsSE/H/0210/007 Greece 31823/12-05-2015 Reminyl 24mg καψάκια παρατεταμένης αποδέσμευσης, σκληρά 08557/0054 Reminyl XL 24mg capsFR/H/0105/001 Greece 3196/13-1-2009 Omacor 15905/0001 Omacor 1000mg soft caps

Version: 11/11/2020 Page: 23 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductFR/H/0204/001 Greece 32046/11-5-2007 Testogel 16468/0005 Testogel 50mg gelNL/H/0215/001 Greece 33038/27-05-2005 Yasmin 00010/0571 YasminDE/H/2020/009 Greece 33651/25.4.2013 Palexia retard 25mg δισκία παρατεταμένης αποδέσμευσης 21727/0051 Palexia SR 25mg tabsIE/H/0574/001 Greece 3439/22-01-2007 Rectogesic 4mg/g 16508/0037 Rectogesic ointmentSE/H/0304/001 Greece 35253/19-10-2005 Avodart 0.5mg 19494/0006 Avodart 0.5mg soft capsSE/H/0568/001 Greece 35363/17-05-2012 Matrifen 12 μικρογραμμάρια/ώρα, διαδερμικό έμπλαστρο 16189/0014 Matrifen 12 micrograms/hour PatchSE/H/0568/002 Greece 35364/17-05-2012 Matrifen 25 μικρογραμμάρια/ώρα, διαδερμικό έμπλαστρο 16189/0015 Matrifen 25 micrograms/hour PatchSE/H/0568/003 Greece 35365/17-05-2012 Matrifen 50 μικρογραμμάρια/ώρα, διαδερμικό έμπλαστρο 16189/0016 Matrifen 50 micrograms/hour PatchSE/H/0568/004 Greece 35366/17-05-2012 Matrifen 75 μικρογραμμάρια/ώρα, διαδερμικό έμπλαστρο 16189/0017 Matrifen 75 micrograms/hour PatchSE/H/0568/005 Greece 35367-17-05-2012 Matrifen 100 μικρογραμμάρια/ώρα, διαδερμικό έμπλαστρο 16189/0018 Matrifen 100 micrograms/hour PatchDE/H/0899/003 Greece 36150/94/27-4-1995 Neurontin 400mg 00057/0537 Neurontin 400mg capsSE/H/0110/009 Greece 36175/26-05-2015 Topamac 50mg καψάκια, σκληρά 00242/0350 Topamax 50mg capsSE/H/0110/002 Greece 36178/26.05.2015 Topamac 50mg 00242/0302 Topamax 50mg tabsFR/H/0416/002 Greece 36383/25-07-2008 Ciproxin 500mg film-coated tablets 00010/0147 Ciproxin 500mg tabsFI/H/0139/001 Greece 36486/31-05-07 Sabril 500mg tablets 04425/0171 Sabril 500mg tabsDE/H/0396/001 Greece 37263/16-9-2011 Ezetrol 10mg 00025/0609 Ezetrol 10mg tabsDE/H/0496/003 Greece 37263/16-9-2011 Inegy Δισκία 10mg/40mg 00025/0611 Inegy 10mg/40mg tabsAT/H/0904/001 Greece 37376/07/4-4-2008 Arimidex 1mg 17901/0002 Arimidex 1mg tabsNL/H/2081/001 Greece 3775/21.01.2005 Losec 10mg capsule 17901/0132 Losec 10mg capsNL/H/2081/002 Greece 3775/21.01.2005 Losec 20mg capsule 17901/0133 Losec 20mg capsNL/H/2081/003 Greece 3775/21.01.2005 Losec 40mg capsule 17901/0134 Losec 40mg capsNL/H/0653/001 Greece 38726/9-5-2014 Dexafree 1 mg/ ml, οφθαλμικές σταγόνες, διάλυμα σε περιέκτη μίας δόσης 20162/0013 Dexafree 1mg/ml eye dropsCZ/H/0939/001 Greece 38943/15-6-2006 Postinor 1500 04854/0150 Levonelle 1500mcg tabsSE/H/1985/001 Greece 39183/12-06-2008 Clobex, Shampoo 500mcg/g 10590/0052 Etrivex 500 micrograms/g shampooSE/H/0406/003 Greece 39253/11-06-2007 Diovan επικαλυμμένα με λεπτό υμένιο δισκία 80 mg 00101/0600 Diovan 80mg tabsSE/H/0406/004 Greece 39254/11-06-2007 Diovan επικαλυμμένα με λεπτό υμένιο δισκία 160 mg 00101/0601 Diovan 160mg tabsSE/H/0406/005 Greece 39255/11-06-2007 Diovan επικαλυμμένα με λεπτό υμένιο δισκία 40 mg 00101/0599 Diovan 40mg tabsNL/H/1540/003 Greece 39494/12-6-07 Lamictal 100mg tablets 00003/0274 Lamictal 100mg tabsIT/H/0774/001 Greece 39667/9-6-2015 Lyrinel 5mg δισκία παρατεταμένης αποδέσμευσης 00242/0385 Lyrinel XL 5mg tabsIT/H/0744/002 Greece 39668/9-6-2015 Lyrinel 10mg δισκία παρατεταμένης αποδέσμευσης 00242/0386 Lyrinel XL 10mg tabsNL/H/3915/003 Greece 39752/08.04.2019 Durogesic 50 μικρογραμμάρια/ώρα διαδερμικό έμπλαστρο 00242/0193 Durogesic DTrans 50ug/hrNL/H/3915/004 Greece 39753/08.04.2019 Durogesic 75 μικρογραμμάρια/ώρα διαδερμικό έμπλαστρο 00242/0194 Durogesic DTrans 75ug/hrNL/H/3915/005 Greece 39754/08.04.2019 Durogesic 100 μικρογραμμάρια/ώρα διαδερμικό έμπλαστρο 00242/0195 Durogesic DTrans 100ug/hrNL/H/3915/001 Greece 39755/08.04.2019 Durogesic 12 μικρογραμμάρια/ώρα διαδερμικό έμπλαστρο 00242/0409 Durogesic DTrans 12ug/hrSE/H/0110/001 Greece 39906/96/18.4.97 Topamac 25mg 00242/0301 Topamax 25mg tabsSE/H/0110/002 Greece 39907/96/18.4.97 Topamac 50mg 00242/0302 Topamax 50mg tabsSE/H/0110/003 Greece 39908/93/18.4.97 Topamac 100mg 00242/0303 Topamax 100mg tabsSE/H/0110/004 Greece 39909/96/18.4.97 Topamac 200mg 00242/0304 Topamax 200mg tabsNL/H/1540/001 Greece 40629/95/6.3.96 Lamictal 25mg tablets 00003/0272 Lamictal 25mg tabsDE/H/4019/005 Greece 4097/3.11.94 Sandimmun Neoral 100mg/ml 00101/0390 Neoral 100mg/ml solutionNL/H/0156/008 Greece 41049/2-6-2008 Seroquel XR 50mg δισκία παρατεταμένης αποδέσμευσης 50827/0006 Seroquel XL 50mg tabsNL/H/0156/009 Greece 41051/2-6-2008 Seroquel XR 200mg δισκία παρατεταμένης αποδέσμευσης 50827/0008 Seroquel XL 200mg tabsNL/H/0156/010 Greece 41053/2-6-2008 Seroquel XR 300mg δισκία παρατεταμένης αποδέσμευσης 50827/0009 Seroquel XL 300mg tabsNL/H/0156/011 Greece 41054/2-6-2008 Seroquel XR 400mg δισκία παρατεταμένης αποδέσμευσης 50827/0010 Seroquel XL 400mg tabsDK/H/0134/002 Greece 41844/12/21-5-2013 Cosopt PF (20+5) mg/1ml 16058/0015 Cosopt SDUDE/H/0384/001 Greece 41922/17-06-2015 Οlmetec 10mg επικαλυμμένο με λεπτό υμένιο δισκίο 08265/0015 Olmetec 10mg tabsDK/H/0339/001 Greece 42425/19-06-2015 Elidel κρέμα 10mg/g 46302/0163 Elidel 1% creamDE/H/0384/001 Greece 42799/28-8-2003 Οlmetec 10mg επικαλυμμένο με λεπτό υμένιο δισκίο 08265/0015 Olmetec 10mg tabs

Version: 11/11/2020 Page: 24 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductDE/H/0384/002 Greece 42800/28-8-2003 Οlmetec 20mg επικαλυμμένο με λεπτό υμένιο δισκίο 08265/0016 Olmetec 20mg tabsDE/H/0384/003 Greece 42801/28-08-2003 Οlmetec 40mg επικαλυμμένο με λεπτό υμένιο δισκίο 08265/0017 Olmetec 40mg tabsIE/H/0574/001 Greece 4371/20-1-2011 Rectogesic 4mg/g 16508/0037 Rectogesic ointmentDE/H/4019/002 Greece 44046/09-01-02-2010 Sandimmun Neoral 25mg 00101/0387 Neoral 25mg soft capsDE/H/4019/005 Greece 44048/29-9-2009 Sandimmun Neoral 100mg/ml 00101/0390 Neoral 100mg/ml solutionDE/H/4019/004 Greece 44055/09/01-02-2010 Sandimmun Neoral 100mg 00101/0389 Neoral 100mg soft capsDE/H/4019/003 Greece 44057/09/01-02-2010 Sandimmun Neoral 50mg 00101/0388 Neoral 50mg soft capsSE/H/0110/001 Greece 44538/07/09.05.2008 Topamac 25mg tabs 00242/0301 Topamax 25mg tabsSE/H/0110/002 Greece 44539/07/09.05.2008 Topamac 50mg tabs 00242/0302 Topamax 50mg tabsSE/H/0110/003 Greece 44542/07/09.05.2008 Topamac 100mg tabs 00242/0303 Topamax 100mg tabsSE/H/0110/004 Greece 44546/07/09.05.2008 Topamac 200mg tabs 00242/0304 Topamax 200mg tabsSE/H/0110/007 Greece 44552/07/29.12.2008 Topamac 15 mg καψάκια σκληρά 00242/0348 Topamax Sprinkle 15mg capsSE/H/0110/008 Greece 44554/07/29.12.2008 Topamac 25 mg καψάκια σκληρά 00242/0349 Topamax Sprinkle 25mg capsSE/H/0110/009 Greece 44558/07/29.12.2008 Topamac 50 mg καψάκια σκληρά 00242/0350 Topamax Sprinkle 50mg capsSE/H/0110/009 Greece 44558/07/29-12-2008 Topamac 50mg καψάκια, σκληρά 00242/0350 Topamax 50mg capsDK/H/3023/001 Greece 4457/23-01-2013 Combigan 2mg/ml + 5mg/ml 41443/0006 Combigan eye dropsDE/H/6220/001 Greece 44774/19-6-2009 Malarone 250+100mg Tablets 10949/0258 Malarone tabsSE/H/0169/001 Greece 44888/27-6-2011 Seretide Diskus, inhalation powder, (50+100)mcg/dose 10949/0314 Seretide 100 AccuhalerSE/H/0169/002 Greece 44890/27-6-2011 Seretide Diskus, inhalation powder, (50+250)mcg/dose 10949/0315 Seretide 250 AccuhalerSE/H/0169/003 Greece 44893-27-6-2011 Seretide Diskus, inhalation powder, (50+500)mcg/dose 10949/0316 Seretide 500 AccuhalerNL/H/0156/012 Greece 45478/27-6-2009 Seroquel XR 150mg δισκία παρατεταμένης αποδέσμευσης 50827/0007 Seroquel XL 150mg tabsSE/H/0139/002 Greece 45485/03-07-2009 Detrusitol 2mg 50622/0016 Detrusitol 2mg tabsDE/H/6157/001 Greece 46866/12/16-05-2013 Xalatan 0,005% οφθαλμικές σταγόνες, διάλυμα 00057/1057 Xalatan eye dropsFI/H/0104/004 Greece 47336/1-7-2011 Singulair granules 4mg/sachet 00025/0440 Singulair Paediatric 4mg granulesNL/H/1540/001 Greece 48167/06/11-6-07 Lamictal 25mg tablets 00003/0272 Lamictal 25mg tabsDK/H/0134/001 Greece 48236/8-7-2010 COSOPT, eye drops, solution (2+0,5)% w/v 16058/0016 Cosopt solutionSE/H/1861/002 Greece 48254/5-11-2008 Alvesco pressurised inhalation, solution 160 mcg/dose 17901/0298 Alvesco 160 inhalerSE/H/0568/004 Greece 4901/27-01-2016 Matrifen 75 μικρογραμμάρια/ώρα, διαδερμικό έμπλαστρο 16189/0017 Matrifen 75 micrograms/hour PatchNL/H/0566/003 Greece 49339/13/18-03-2014 Seroxat 2mg/ml 10592/0092 Seroxat 20mg/10ml suspFR/H/0649/001 Greece 49566/14-11-2014 Amoxil 500mg/cap 00038/0105 Amoxil 500mg capsDE/H/0109/002 Greece 49595/24-7-2008 Lipitor 20mg film-coated tablets 50622/0039 Lipitor 20mg tabsSE/H/1821/001 Greece 49981/12-10-2007 Nasonex nasal spray suspension 0.05% w/w 00025/0587 Nasonex 50ug/actuation nasal sprayDE/H/6124/001 Greece 50787/27-6-2013 Actiq 200 μικρογραμμάρια, πεπιεσμένος τροχίσκος με ενσωματωμένο στοματικό εξάρτ 14776/0092 Actiq 200mcg lozengeDE/H/6124/003 Greece 50789/27-6-2013 Actiq 600 μικρογραμμάρια, πεπιεσμένος τροχίσκος με ενσωματωμένο στοματικό εξάρτ 14776/0094 Actiq 600mcg lozengeDE/H/6124/002 Greece 50792/27-6-2013 Actiq 400 μικρογραμμάρια, πεπιεσμένος τροχίσκος με ενσωματωμένο στοματικό εξάρτ 14776/0093 Actiq 400mcg lozengeDE/H/6124/004 Greece 50793/27-6-2013 Actiq 800 μικρογραμμάρια, πεπιεσμένος τροχίσκος με ενσωματωμένο στοματικό εξάρτ 14776/0095 Actiq 800mcg lozengeSE/H/0230/001 Greece 51516/20.07.2011 Symbicort Turbuhaler 80/4.5 mcg 17901/0091 Symbicort 100/6 TurbohalerSE/H/0229/001 Greece 51517/20.07.2011 Symbicort Turbuhaler 160/4.5 mcg 17901/0092 Symbicort 200/6 TurbohalerSE/H/0229/002 Greece 51518/20-07-2011 Symbicort Turbuhaler Inhalation Powder (320+9)mcg/dose 17901/0200 Symbicort 400/12 TurbohalerIE/H/0165/003 Greece 51620/31-7-07 Prograf 5mg hard capsules 00166/0204 Prograf 5mg hard capsDE/H/6124/006 Greece 51708/01-07-2013 Actiq 1600 μικρογραμμάρια, πεπιεσμένος τροχίσκος με ενσωματωμένο στοματικό εξάρ14776/0097 Actiq 1600mcg lozengeDE/H/6124/005 Greece 51709/01-07-2013 Actiq 1200 μικρογραμμάρια, πεπιεσμένος τροχίσκος με ενσωματωμένο στοματικό εξάρ14776/0096 Actiq 1200mcg lozengeDE/H/0871/002 Greece 51871/11-06-2014 Foster Nexthaler Inhalation Powder (100+6)mcg/dose 08829/0173 Fostair Nexthaler 100/6NL/H/0653/001 Greece 51971/29-06-2016 Dexafree 1 mg/ ml, οφθαλμικές σταγόνες, διάλυμα σε περιέκτη μίας δόσης 20162/0013 Dexafree 1mg/ml eye dropsSE/H/0571/001 Greece 52737/19-7-2011 Tostran 2% gel 16508/0025 Tostran 2% gelSE/H/0481/002 Greece 52739/19-7-2011 Fosrenol 500 mg μασώμενα δισκία 08081/0042 Fosrenol 500mg tabsSE/H/0481/003 Greece 52740/19-7-2011 Fosrenol 750 mg μασώμενα δισκία 08081/0043 Fosrenol 750mg tabsDE/H/4019/005 Greece 53354/14-09-2011 Sandimmun Neoral 100mg/ml 00101/0390 Neoral 100mg/ml solution

Version: 11/11/2020 Page: 25 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductNL/H/0566/003 Greece 53553/26-7-2011 Seroxat 2mg/ml 10592/0092 Seroxat 20mg/10ml suspFR/H/0070/001 Greece 53809/03-05-2010 Trusopt 20 mg/ml 16058/0014 Trusopt Eye DropsFR/H/0195/001 Greece 53971/21-8-2008 Pitunal 2.5mg 16239/0017 Migard 2.5mg tabsDK/H/0339/001 Greece 53978/21-08-2008 Elidel κρέμα 10mg/g 46302/0163 Elidel 1% creamDK/H/0339/001 Greece 54077/11/3-1-2012 Elidel κρέμα 10mg/g 46302/0163 Elidel 1% creamNL/H/0156/002 Greece 54573/15-06-2017 Seroquel 100mg επικαλυμμένα με λεπτό υμένιο δισκία 50827/0003 Seroquel 100mg tabsNL/H/0156/008 Greece 54579/15.06.2017 Seroquel XR 50mg δισκία παρατεταμένης αποδέσμευσης 50827/0006 Seroquel XL 50mg tabsDE/H/6220/001 Greece 54804/21-10-2003 Malarone Tablets 10949/0258 Malarone tabsNL/H/2081/002 Greece 5561/29-01-2013 Losec 20mg capsule 17901/0133 Losec 20mg capsNL/H/0156/002 Greece 55778/21.08.2015 Seroquel 100mg επικαλυμμένα με λεπτό υμένιο δισκία 50827/0003 Seroquel 100mg tabsSE/H/0643/001 Greece 55925/29-7-2009 Metoject 50 mg/ml 11587/0046 Metoject 50mg/ml soln for injSE/H/0169/001 Greece 55976/30-8-2007 Seretide Diskus, inhalation powder, (50+100)mcg/dose 10949/0314 Seretide 100 AccuhalerSE/H/0169/002 Greece 55977/30-8-2007 Seretide Diskus, inhalation powder, (50+250)mcg/dose 10949/0315 Seretide 250 AccuhalerSE/H/0169/003 Greece 55978/30-8-2007 Seretide Diskus, inhalation powder, (50+500)mcg/dose 10949/0316 Seretide 500 AccuhalerDE/H/5770/002 Greece 55980/30-08-2007 Seretide 25/125mcg inhaler 10949/0338 Seretide 125 EvohalerDE/H/5770/003 Greece 55981/30-08-2007 Seretide 25/250mcg inhaler 10949/0339 Seretide 250 EvohalerSE/H/0406/006 Greece 56004/30-08-2007 Diovan επικαλυμμένα με λεπτό υμένιο δισκία 320 mg 00101/0726 Diovan 320mg tabsSE/H/0121/002 Greece 58328/12.09.2008 Oxez Turbuhaler 9 mcg/dose 17901/0153 Oxis Turbohaler 12FR/H/0645/004 Greece 58786/25-08-2011 Humulin Regular 100IU/ml cartridge 00006/0668 Humulin S 100IU/ml cartridgeFR/H/0645/002 Greece 58787/25-08-2011 Humulin NPH 100IU/ml 00006/0666 Humulin I 100IU/ml suspension in vialFR/H/0645/005 Greece 58789/25-08-2011 Humulin NPH 100IU/ml cartridge 00006/0669 Humulin I 100IU/ml cartridgeFR/H/0645/003 Greece 58790/25-08-2011 Humulin M3 30/70 vial 00006/0667 Humulin M3 100IU/ml suspension in vialFR/H/0645/006 Greece 58792/25-08-2011 Humulin M3 30/70 cartridge 00006/0670 Humulin M3 100IU/ml cartridgeSE/H/0147/001 Greece 5887/11-8-98 Cerazette 0,075 μικρογραμμάρια, επικαλυμμένα με υμένιο δισκία 00025/0562 Cerazette 75mcg tabsDK/H/0279/002 Greece 59058/13/17-03-2014 Dοvobet 50 micrograms/0.5 mg/g γέλη 05293/0005 Dovobet gelSE/H/0211/001 Greece 59075/25.09.2006 Nexium 20mg 17901/0068 Nexium 20mg tabsFI/H/0313/001 Greece 5917/26-01-2011 Nebido 1000 mg/4 ml, ενέσιμο διάλυμα 00010/0549 Nebido 1000mg/4ml injSE/H/0565/001 Greece 59554/07-09-2009 Co-Diovan (80+12,5) mg επικαλυμμένα με λεπτό υμένιο δισκία 00101/0480 Co-Diovan 80/12.5mg tabsSE/H/0565/002 Greece 59555/07-09-2009 Co-Diovan (160+12,5) mg επικαλυμμένα με λεπτό υμένιο δισκία 00101/0650 Co-Diovan 160/12.5mg tabsSE/H/0565/003 Greece 59556/07-09-2009 Co-Diovan (160+25) mg επικαλυμμένα με λεπτό υμένιο δισκία 00101/0651 Co-Diovan 160/25mg tabsAT/H/0754/001 Greece 59658/12-11-2003 Clexane 12.000IU (120mg)/0,8mL ενέσιμο διάλυμα 04425/0185 Clexane Forte 12000IU (120mg)/0.8mlAT/H/0754/002 Greece 59659/12-11-2003 Clexane 15.000IU (150mg)/0,8mL ενέσιμο διάλυμα 04425/0185 Clexane Forte 15000IU (150mg)/1mlIE/H/0574/001 Greece 6035/22-01-2019 Rectogesic 4mg/g 16508/0037 Rectogesic ointmentSE/H/0198/001 Greece 61098/9-9-2010 Celebrex Καψάκιο, σκληρό 100 mg 50622/0011 Celebrex 100mg capsSE/H/0198/002 Greece 61100/9-9-2010 Celebrex Καψάκιο, σκληρό 200 mg 50622/0012 Celebrex 200mg capsNL/H/0487/001 Greece 61101/09-09-2010 Vesicare 5mg Film-Coated Tablets 00166/0197 Vesicare 5mg tabsNL/H/0487/002 Greece 61104/09-09-2010 Vesicare 10mg Film-Coated Tablets 00166/0198 Vesicare 10mg tabsNL/H/0718/001 Greece 61514/12/25.06.2013 Spiriva Respimat 2,5 μικρογραμμάρια, διάλυμα για εισπνοή 14598/0084 Spiriva RespimatDE/H/6015/001 Greece 61567/24-09-2007 Indoxyl 10mg/g + 50mg/g gel 19494/0075 Duac Once Daily 10+50mg/g GelSE/H/1861/002 Greece 64488/19-9-2011 Alvesco pressurised inhalation, solution 160 mcg/dose 17901/0298 Alvesco 160 inhalerNL/H/0732/001 Greece 64554/13-10-2008 Mezavant 1200mg, γαστροανθεκτικά δισκία παρατεταμένης αποδέσμευσης 08081/0040 Mezavant XL 1200mg tabsNL/H/0577/001 Greece 65950/24-10-06 Lopid 600mg 00057/0535 Lopid 600mg tabsNL/H/0380/001 Greece 66317/5-10-2010 Angeliq film-coated tablet (1+2)mg/Tablet 00010/0518 Angeliq tabsSE/H/1826/001 Greece 67597/30.11.2004 Pariet 20mg magensaftresistente tabletten 10555/0008 Pariet 20mg tabsNL/H/0299/001 Greece 67681/17-10-2007 Spiriva 18 μικρογραμμάρια, κόνις για εισπνοή, σκληρό καψάκιο 14598/0062 Spiriva 18mcg inhalation powderNL/H/0299/001 Greece 67681/17-10-2007 Spiriva 18 μικρογραμμάρια, κόνις για εισπνοή, σκληρό καψάκιο 14598/0062 Spiriva 18mcg inhalation powderNL/H/3915/001 Greece 68131/16-11-2005 Durogesic 12 μικρογραμμάρια/ώρα διαδερμικό έμπλαστρο 00242/0409 Durogesic DTrans 12ug/hr

Version: 11/11/2020 Page: 26 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductNL/H/3915/002 Greece 68133/16-11-2005 Durogesic 25 μικρογραμμάρια/ώρα διαδερμικό έμπλαστρο 00242/0192 Durogesic DTrans 25ug/hrNL/H/3915/003 Greece 68134/16-11-2005 Durogesic 50 μικρογραμμάρια/ώρα διαδερμικό έμπλαστρο 00242/0193 Durogesic DTrans 50ug/hrNL/H/3915/004 Greece 68135/16-11-2005 Durogesic 75 μικρογραμμάρια/ώρα διαδερμικό έμπλαστρο 00242/0194 Durogesic DTrans 75ug/hrNL/H/3915/005 Greece 68136/16-11-2005 Durogesic 100 μικρογραμμάρια/ώρα διαδερμικό έμπλαστρο 00242/0195 Durogesic DTrans 100ug/hrSE/H/0581/004 Greece 68911/11-9-2013 Serosmine 225 mg δισκία παρατεταμένης αποδέσμευσης 01883/0341 Venlalic XL 225mg tabsDE/H/2251/001 Greece 68913/10/7-6-2011 Duodart 0,5/0,4 mg σκληρά καψάκια 19494/0046 Combodart 0.5mg/0.4mg capsDE/H/6220/001 Greece 71029/6-10-2016 Malarone 250+100mg Tablets 10949/0258 Malarone tabsNL/H/0380/001 Greece 71220/5-11-2008 Angeliq film-coated tablet (1+2)mg/Tablet 00010/0518 Angeliq tabsPT/H/2299/002 Greece 71848/6-11-2013 Arcoxia 90mg Film-coated Tablets 00025/0643 Arcoxia 90mg tabsPT/H/2299/003 Greece 71849/6-11-2013 Arcoxia 120mg film-coated tablets 00025/0644 Arcoxia 120mg tabsDE/H/5733/001 Greece 71851/7-11-2013 Versatis 700mg έμπλαστρο φαρμακούχο 21727/0016 Versatis 700mg medicated plasterNL/H/4790/001 Greece 74512/18-11-2008 Zanidip 10mg επικαλυμμένo με λεπτό υμένιο δισκίο 04595/0005 Zanidip 10mg tabsNL/H/4790/002 Greece 74514/18-11-2008 Zanidip 20mg επικαλυμμένo με λεπτό υμένιο δισκίο 04595/0010 Zanidip 20mg tabsFR/H/0228/001 Greece 7480/9-12-2005 Duraphat 5000 toothpaste 500mg/100g 00049/0050 Duraphat 5000ppm fluoride toothpasteDE/H/0871/001 Greece 75230/1-11-2011 Foster 100/6 μικρογραμμάρια ανά ψεκασμό Διάλυμα για εισπνοή υπό πίεση 08829/0156 Fostair 100/6 inhalerAT/H/0983/001 Greece 75518/20-11-07 Aricept 5mg 10555/0006 Aricept 5mg tabsAT/H/0983/002 Greece 75519/20-11-07 Aricept 10mg 10555/0007 Aricept 10mg tabsDE/H/3355/001 Greece 77148/17/12-07-2019 Dymista Ρινικό Εκνέφωμα 137 μικρογραμμάρια / 50 μικρογραμμάρια ανά ψεκασμό 15142/0258 Dymista Nasal SprayNL/H/1540/004 Greece 78118/2-12-2008 Lamictal 200mg tablets 00003/0297 Lamictal 200mg tabsNL/H/1540/001 Greece 78119/2.12.2008 Lamictal 25mg tablets 00003/0272 Lamictal 25mg tabsNL/H/1540/002 Greece 78120/2-12-2008 Lamictal 50mg tablets 00003/0273 Lamictal 50mg tabsNL/H/1540/003 Greece 78121/2-12-2008 Lamictal 100mg tablets 00003/0274 Lamictal 100mg tabsDE/H/0769/002 Greece 78443/3-12-2008 Superace (50+25)mg δισκία 00034/0263 Capozide tabsDE/H/6007/004 Greece 785/20.01.2010 Concerta 27mg δισκία παρατεταμένης αποδέσμευσης 00242/0400 Concerta XL 27mg tabsDK/H/0168/002 Greece 78900/17/26-10-2018 Trileptal 300mg 00101/0582 Trileptal 300mg tabsDE/H/0871/001 Greece 79619/6-12-2007 FOSTER 100/6 μικρογραμμάρια ανά ψεκασμό Διάλυμα για εισπνοή υπό πίεση 08829/0156 Fostair 100/6 inhalerIE/H/0574/001 Greece 80477/10-11-2009 Rectogesic 4mg/g 16508/0037 Rectogesic ointmentNL/H/3915/002 Greece 83556/17/08.04.2019 Durogesic 25 μικρογραμμάρια/ώρα διαδερμικό έμπλαστρο 00242/0192 Durogesic DTrans 25ug/hrSE/H/0211/001 Greece 84225/11/02-02-2012 Nexium 20mg 17901/0068 Nexium 20mg tabsSE/H/0211/002 Greece 84226/11/02.02.2012 Nexium 40mg 17901/0069 Nexium 40mg tabsFI/H/0104/004 Greece 84607/30-11-2015 Singulair granules 4mg/sachet 00025/0440 Singulair Paediatric 4mg granulesDK/H/0168/002 Greece 84678/30-11-2015 Trileptal 300mg 00101/0582 Trileptal 300mg tabsDK/H/0168/004 Greece 84680/30-11-2015 Trileptal 60mg/ml Πόσιμο Εναιώρημα 00101/0631 Trileptal 60mg/ml suspensionDK/H/2848/001 Greece 86189/07-12-2015 Iopidine 5mg/ml 00101/0996 Iopidine 5mg/ml eye dropsDK/H/2871/001 Greece 86874/21-12-2010 Picoprep 03194/0014 PicolaxNL/H/0343/001 Greece 87240/06-10-2014 Crestor 10mg 17901/0201 Crestor 10mg tabsNL/H/0343/004 Greece 87243/06-10-2014 Crestor 5mg 17901/0243 Crestor 5mg tabsDE/H/6007/001 Greece 88894/20.01.2010 Concerta 18mg δισκία παρατεταμένης αποδέσμευσης 00242/0372 Concerta XL 18mg tabsDE/H/6007/002 Greece 88895/20.01.2010 Concerta 36mg δισκία παρατεταμένης αποδέσμευσης 00242/0373 Concerta XL 36mg tabsIT/H/0144/001 Greece 90395/17-12-2009 Nebivolol Generics 5mg Δισκία 04569/0885 Nebivolol 5mg tabsFR/H/0288/001 Greece 92405/12/11-1-2013 Geltim eye gel 1mg/g 20162/0010 Tiopex 1mg/g eye gel SDUPT/H/2299/004 Greece 9262/14-2-2012 Arcoxia 30mg 00025/0641 Arcoxia 30mg tabsPT/H/2299/003 Greece 9272/14-2-2012 Arcoxia 120mg film-coated tablets 00025/0644 Arcoxia 120mg tabsNL/H/0343/001 Greece 9345/02-02-2009 Crestor 10mg 17901/0201 Crestor 10mg tabsNL/H/0343/002 Greece 9347/02-02-2009 Crestor 20mg 17901/0202 Crestor 20mg tabsNL/H/0343/004 Greece 9350/02-02-2009 Crestor 5mg 17901/0243 Crestor 5mg tabsPT/H/2325/002 Greece 9356/2-2-09 Tanatril δισκία 5mg 20012/0004 Tanatril 5mg tabsPT/H/2325/003 Greece 9358/2-2-09 Tanatril δισκία 10mg 20012/0005 Tanatril 10mg tabs

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductPT/H/2325/004 Greece 9359/2-2-09 Tanatril δισκία 20mg 20012/0006 Tanatril 20mg tabsNL/H/0343/004 Greece 979/07/23-01-2008 Crestor 5mg 17901/0243 Crestor 5mg tabsDE/H/0299/001 Hungary 8514 Xyzal 5mg filmtabletta 00039/0539 Xyzal 5mg tabsNL/H/0718/001 Hungary 8632 Spiriva Respimat 2,5 mikrogramm inhalációs oldat 14598/0084 Spiriva RespimatDE/H/2251/001 Hungary 21305 Duodart 0,4mg/0,5mg kemény kapszula 19494/0046 Combodart 0.5mg/0.4mg capsDE/H/5733/001 Hungary 21784 Versatis 700mg gyógyszeres tapasz 21727/0016 Versatis 700mg medicated plasterNL/H/0732/001 Hungary 21909 Mezavant 1200mg gyomornedv‑ellenálló retard tabletta 08081/0040 Mezavant XL 1200mg tabsAT/H/0754/001 Hungary 4097/12-13 Clexane Forte 12000NE (120mg)/0,8ml oldatos injekció elõretöltött fecskendõben 04425/0185 Clexane Forte 12000IU (120mg)/0.8mlSE/H/0565/001 Hungary 6552/01-04 Diovan HCT 80/12.5mg filmtabletta 00101/0480 Co-Diovan 80/12.5mg tabsSE/H/0565/002 Hungary 6552/05-08 Diovan HCT 160/12.5mg filmtabletta 00101/0650 Co-Diovan 160/12.5mg tabsSE/H/0565/003 Hungary 6552/09-12 Diovan HCT 160/25mg filmtabletta 00101/0651 Co-Diovan 160/25mg tabsNL/H/0299/001 Hungary 8632/01-02 Spiriva 18 mikrogramm inhalációs por kemény kapszulában 14598/0062 Spiriva 18mcg inhalation powderNL/H/0487/001 Hungary 10051/01 Vesicare 5mg 00166/0197 Vesicare 5mg tabsNL/H/0487/002 Hungary 10052/01 Vesicare 10mg 00166/0198 Vesicare 10mg tabsFI/H/0313/001 Hungary 10175/01 Nebido 250mg/ml oldatos injekció 00010/0549 Nebido 1000mg/4ml injDE/H/0528/001 Hungary 10307/02 Atimos 12 micrograms/actuation pressurised inhaltion solution 08829/0154 Atimos ModuliteIE/H/0715/001 Hungary 1352/03 Augmentin 250mg/125mg filmtabletta 00038/0270 Augmentin 375mg tabsPT/H/2363/001 Hungary 1352/05-06 Augmentin Duo 400mg/57mg/5ml pro belsőleges szuszpenzióhoz 10592/0070 Augmentin Duo 400/57DE/H/6220/001 Hungary 20107/01 Malarone 250 mg/100 mg filmtabletta 10949/0258 Malarone tabsFR/H/0265/002 Hungary 20179/02 Coverex AS 5mg filmtabletta 05815/0036 Coversyl Arginine 5mg tabsFR/H/0265/003 Hungary 20179/03 Coverex AS 10mg filmtabletta 05815/0037 Coversyl Arginine 10mg tabsSE/H/1876/001 Hungary 20251/01 Serevent Evohaler 25 mikrogramm/adag tulnyomasos inhalacios szuszpenzio 10949/0369 Serevent 25 EvohalerDE/H/0871/001 Hungary 20363/01 FOSTER 100 mikrogramm/6 mikrogramm túlnyomásos inhalációs oldat 08829/0156 Fostair 100/6 inhalerDE/H/0871/001 Hungary 20363/02 FOSTER 100 mikrogramm/6 mikrogramm túlnyomásos inhalációs oldat 08829/0156 Fostair 100/6 inhalerDE/H/0871/002 Hungary 20363/03 Foster Nexthaler 100 mikrogramm/6 mikrogramm/adag inhalációs por 08829/0173 Fostair Nexthaler 100/6DE/H/0871/002 Hungary 20363/04 Foster Nexthaler 100 mikrogramm/6 mikrogramm/adag inhalációs por 08829/0173 Fostair Nexthaler 100/6DE/H/0871/002 Hungary 20363/05 Foster Nexthaler 100 mikrogramm/6 mikrogramm/adag inhalációs por 08829/0173 Fostair Nexthaler 100/6DK/H/2871/001 Hungary 21383/01 Picoprep 03194/0014 PicolaxDE/H/2020/004 Hungary 21638/04 Palexias 50mg retard tabletta 21727/0041 Palexia SR 50mg tabsDE/H/2020/005 Hungary 21638/05 Palexias 100mg retard tabletta 21727/0042 Palexia SR 100mg tabsDE/H/2020/006 Hungary 21638/06 Palexias 150mg retard tabletta 21727/0043 Palexia SR 150mg tabsDE/H/2020/007 Hungary 21638/07 Palexias 200mg retard tabletta 21727/0044 Palexia SR 200mg tabsDE/H/2020/008 Hungary 21638/08 Palexias 250mg retard tabletta 21727/0045 Palexia SR 250mg tabsDE/H/2020/009 Hungary 21638/09 Palexias 25mg retard tabletta 21727/0051 Palexia SR 25mg tabsDE/H/2915/001 Hungary 21936/01 Latanoprost Pfizer 0,05 mg/ml oldatos szemcsepp 00057/1221 Latanoprost Pfizer 50ug/ml eye dropsDE/H/2915/001 Hungary 21936/02 Latanoprost Pfizer 0,05 mg/ml oldatos szemcsepp 00057/1221 Latanoprost Pfizer 50ug/ml eye dropsDE/H/3355/001 Hungary 22423/03 Dymista szuszpenziós orrspray 137 mikrogramm/50 mikrogramm befújásonként 15142/0258 Dymista Nasal SprayDE/H/3355/001 Hungary 22423/04 Dymista szuszpenziós orrspray 137 mikrogramm/50 mikrogramm befújásonként 15142/0258 Dymista Nasal SprayES/H/0653/001 Hungary 23055/01 Braltus 10 mikrogramm adagolt inhalacios por kemeny kapszulaban 00289/1870 Braltus 10mcg inhalation powderAT/H/0754/002 Hungary 4097/14-15 Clexane Forte 15000NE (150mg)/01ml oldatos injekció elõretöltött fecskendõben 04425/0185 Clexane Forte 15000IU (150mg)/1mlDE/H/4019/005 Hungary 4200/01 Sandimmun Neoral 100mg/ml belsõleges oldat 00101/0390 Neoral 100mg/ml solutionDE/H/4019/001 Hungary 4200/02 Sandimmun Neoral 10mg lágy kapszula 00101/0483 Neoral 10mg soft capsDE/H/4019/002 Hungary 4200/03 Sandimmun Neoral 25mg lágy kapszula 00101/0387 Neoral 25mg soft capsDE/H/4019/003 Hungary 4200/04 Sandimmun Neoral 50mg lágy kapszula 00101/0388 Neoral 50mg soft capsDE/H/4019/004 Hungary 4200/05 Sandimmun Neoral 100mg lágy kapszula 00101/0389 Neoral 100mg soft capsNL/H/1732/002 Hungary 4342/01 Zoloft 50mg Filmtabletta 00057/0308 Lustral 50mg tabsNL/H/3915/002 Hungary 4530/01 Durogesic 25 mikrogramm/óra transzdermális tapasz 00242/0192 Durogesic DTrans 25ug/hrNL/H/3915/003 Hungary 4530/02 Durogesic 50 mikrogramm/óra transzdermális tapasz 00242/0193 Durogesic DTrans 50ug/hr

Version: 11/11/2020 Page: 28 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductNL/H/3915/004 Hungary 4530/03 Durogesic 75 mikrogramm/óra transzdermális tapasz 00242/0194 Durogesic DTrans 75ug/hrNL/H/3915/005 Hungary 4530/04 Durogesic 100 mikrogramm/óra transzdermális tapasz 00242/0195 Durogesic DTrans 100ug/hrNL/H/3915/001 Hungary 4530/05 Durogesic 12 mikrogramm/óra transzdermális tapasz 00242/0409 Durogesic DTrans 12ug/hrDE/H/3456/005 Hungary 5037/01 Diflucan 10mg/ml belsoleges szuszpenzio 00057/0343 Diflucan 10mg/ml oral suspensionNL/H/2081/001 Hungary 5114/02 Losec 10mg gyomornedv‑ellenálló kemény kapszula 17901/0132 Losec 10mg capsNL/H/2081/001 Hungary 5114/03 Losec 10mg gyomornedv‑ellenálló kemény kapszula 17901/0132 Losec 10mg capsNL/H/2081/002 Hungary 5114/04 Losec 20mg gyomornedv‑ellenálló kemény kapszula 17901/0133 Losec 20mg capsNL/H/2081/002 Hungary 5114/05 Losec 20mg gyomornedv‑ellenálló kemény kapszula 17901/0133 Losec 20mg capsNL/H/2081/002 Hungary 5114/06 Losec 20mg gyomornedv‑ellenálló kemény kapszula 17901/0133 Losec 20mg capsNL/H/0156/009 Hungary 5683/03 Seroquel XR200 mg retard tabletta 50827/0008 Seroquel XL 200mg tabsNL/H/0156/010 Hungary 5683/04 Seroquel XR300 mg retard tabletta 50827/0009 Seroquel XL 300mg tabsNL/H/0156/011 Hungary 5683/05 Seroquel XR400 mg retard tabletta 50827/0010 Seroquel XL 400mg tabsNL/H/0156/012 Hungary 5683/08 Seroquel XR150 mg retard tabletta 50827/0007 Seroquel XL 150mg tabsNL/H/0156/012 Hungary 5683/09 Seroquel XR150 mg retard tabletta 50827/0007 Seroquel XL 150mg tabsNL/H/0156/009 Hungary 5683/11 Seroquel XR200 mg retard tabletta 50827/0008 Seroquel XL 200mg tabsNL/H/0156/010 Hungary 5683/12 Seroquel XR300 mg retard tabletta 50827/0009 Seroquel XL 300mg tabsNL/H/0156/011 Hungary 5683/13 Seroquel XR400 mg retard tabletta 50827/0010 Seroquel XL 400mg tabsNL/H/0156/001 Hungary 5863/01 Seroquel 25mg filmtabletta 50827/0002 Seroquel 25mg tabsNL/H/0156/008 Hungary 5863/02 Seroquel XR50 mg retard tabletta 50827/0006 Seroquel XL 50mg tabsNL/H/0156/007 Hungary 5863/06 Seroquel 300mg filmtabletta 50827/0005 Seroquel 300mg tabsNL/H/0156/007 Hungary 5863/07 Seroquel 300mg filmtabletta 50827/0005 Seroquel 300mg tabsNL/H/0156/008 Hungary 5863/10 Seroquel XR50 mg retard tabletta 50827/0006 Seroquel XL 50mg tabsSE/H/1821/001 Hungary 6057/01-02-03 Nasonex 0,05% szuszpenziós adagolt orrspray 00025/0587 Nasonex 50ug/actuation nasal sprayNL/H/1457/001 Hungary 6454/04/05/06/08 Cozaar 12.5mg filmtabletta 00025/0515 Cozaar 12.5mg tabsNL/H/1457/002 Hungary 6454/12/14/16/19/22 Cozaar 50mg filmtabletta 00025/0324 Cozaar 50mg tabsNL/H/1457/003 Hungary 6454/27/29/32/35/38 Cozaar 100mg filmtabletta 00025/0416 Cozaar 100mg tabsNL/H/1458/001 Hungary 6976/01 Hyzaar 50mg/12,5mg filmtabletta 00025/0338 Cozaar Comp 50mg/12.5mgNL/H/1458/003 Hungary 6976/03 Hyzaar Forte 100mg/25mg filmtabletta 00025/0374 Cozaar Comp 100mg/25mgNL/H/1458/003 Hungary 6976/04 Hyzaar Forte 100mg/25mg filmtabletta 00025/0374 Cozaar Comp 100mg/25mgIE/H/0165/002 Hungary 7280/01 Prograf 1mg kemeny kapszula 00166/0203 Prograf 1mg hard capsDK/H/0134/003 Hungary 7662/05 Cosopt Multi 20mg/ml + 5mg/ml tartósítószermentes oldatos szemcsepp 16058/0025 Cosopt iMultiSE/H/0211/002 Hungary 8256/06 Nexium 40mg filmtabletta 17901/0069 Nexium 40mg tabsFR/H/0171/001 Hungary 8448/01-02-03 Diaprel MR 30mg modified release tablets 05815/0019 Diamicron 30mg MR tabsSE/H/0406/004 Hungary 8484/01 Diovan 160mg filmtabletta 00101/0601 Diovan 160mg tabsSE/H/0406/004 Hungary 8484/02 Diovan 160mg filmtabletta 00101/0601 Diovan 160mg tabsSE/H/0406/005 Hungary 8484/05 Diovan 40mg filmtabletta 00101/0599 Diovan 40mg tabsSE/H/0406/005 Hungary 8484/06 Diovan 40mg filmtabletta 00101/0599 Diovan 40mg tabsSE/H/0406/005 Hungary 8484/07 Diovan 40mg filmtabletta 00101/0599 Diovan 40mg tabsSE/H/0406/005 Hungary 8484/08 Diovan 40mg filmtabletta 00101/0599 Diovan 40mg tabsSE/H/0406/003 Hungary 8484/09 Diovan 80mg filmtabletta 00101/0600 Diovan 80mg tabsSE/H/0406/003 Hungary 8484/10 Diovan 80mg filmtabletta 00101/0600 Diovan 80mg tabsSE/H/0406/003 Hungary 8484/11 Diovan 80mg filmtabletta 00101/0600 Diovan 80mg tabsSE/H/0406/003 Hungary 8484/12 Diovan 80mg filmtabletta 00101/0600 Diovan 80mg tabsSE/H/0406/004 Hungary 8484/13 Diovan 160mg filmtabletta 00101/0601 Diovan 160mg tabsSE/H/0406/004 Hungary 8484/14 Diovan 160mg filmtabletta 00101/0601 Diovan 160mg tabsSE/H/0230/001 Hungary 8492/01 Symbicort mite Turbuhaler 4,5 mikrogramm/80 mikrogramm inhalációs por 17901/0091 Symbicort 100/6 TurbohalerSE/H/0230/001 Hungary 8492/02 Symbicort mite Turbuhaler 4,5 mikrogramm/80 mikrogramm inhalációs por 17901/0091 Symbicort 100/6 TurbohalerSE/H/0229/001 Hungary 8492/03 Symbicort Turbuhaler 4,5 mikrogramm/160 mikrogramm inhalációs por 17901/0092 Symbicort 200/6 Turbohaler

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductSE/H/0229/001 Hungary 8492/04 Symbicort Turbuhaler 4,5 mikrogramm/160 mikrogramm inhalációs por 17901/0092 Symbicort 200/6 TurbohalerSE/H/0229/002 Hungary 8492/05 Symbicort forte Turbuhaler 9 mikrogramm/320 mikrogramm inhalációs por 17901/0200 Symbicort 400/12 TurbohalerIE/H/0165/001 Hungary 8681/01 Prograf 0.5mg kemeny kapszula 00166/0206 Prograf 0.5mg hard capsPT/H/2299/003 Hungary 8825/03 Arcoxia 120mg filmtabletta 00025/0644 Arcoxia 120mg tabsPT/H/2299/003 Hungary 8825/04 Arcoxia 120mg filmtabletta 00025/0644 Arcoxia 120mg tabsPT/H/2299/004 Hungary 8825/05 Arcoxia 30mg filmtabletta 00025/0641 Arcoxia 30mg tabsPT/H/2299/001 Hungary 8825/06 Arcoxia 60mg filmtabletta 00025/0642 Arcoxia 60mg tabsPT/H/2299/001 Hungary 8825/07 Arcoxia 60mg filmtabletta 00025/0642 Arcoxia 60mg tabsPT/H/2299/002 Hungary 8825/08 Arcoxia 90mg Filmtabletta 00025/0643 Arcoxia 90mg tabsPT/H/2299/002 Hungary 8825/09 Arcoxia 90mg Filmtabletta 00025/0643 Arcoxia 90mg tabsPT/H/2299/004 Hungary 8825/24 Arcoxia 30mg filmtabletta 00025/0641 Arcoxia 30mg tabsDE/H/0307/001 Ireland 1032/1/1 Transtec 35 micrograms/h transdermal patch 04539/0014 Transtec 35ug/hr patchDE/H/0307/002 Ireland 1032/1/2 Transtec 52.5 micrograms/h transdermal patch 04539/0015 Transtec 52.5ug/hr patchDE/H/0307/003 Ireland 1032/1/3 Transtec 70 micrograms/h transdermal patch 04539/0016 Transtec 70ug/hr patchDE/H/6220/001 Ireland 1077/111/1 Malarone 250mg/100mg film-coated tablets 10949/0258 Malarone tabsDE/H/2251/001 Ireland 1077/118/1 Combodart 0.5mg/0.4mg hard capsules 19494/0046 Combodart 0.5mg/0.4mg capsPT/H/2363/001 Ireland 1077/19/2 Augmentin–Duo 400mg/57mg/5ml Powder for Oral Suspension 10592/0070 Augmentin Duo 400/57SE/H/0169/001 Ireland 1077/46/1 Seretide 100 Diskus 50 microgram/100 microgram / dose inhalation powder 10949/0314 Seretide 100 AccuhalerSE/H/0169/002 Ireland 1077/46/2 Seretide 250 Diskus 50 microgram/250 microgram / dose inhalation powder 10949/0315 Seretide 250 AccuhalerSE/H/0169/003 Ireland 1077/46/3 Seretide 500 Diskus 50 microgram/500 microgram / dose inhalation powder 10949/0316 Seretide 500 AccuhalerDE/H/5770/002 Ireland 1077/46/5 Seretide 125 Evohaler 10949/0338 Seretide 125 EvohalerDE/H/5770/003 Ireland 1077/46/6 Seretide 250 Evohaler 10949/0339 Seretide 250 EvohalerSE/H/1876/001 Ireland 1077/47/5 Serevent Evohaler 25 micrograms per actuation pressurised inhalation suspension 10949/0369 Serevent 25 EvohalerIE/H/0715/001 Ireland 1077/93/7 Augmentin 250mg/125mg film-coated tablets 00038/0270 Augmentin 375mg tabsSE/H/0225/001 Ireland 1107/10/1 Zaditen 0.25mg/ml, eye drops, solution 20162/0019 Zaditen 0.25mg/ml eye dropsDE/H/2020/004 Ireland 1189/007/004 Palexia SR 50mg prolonged-release tablets 21727/0041 Palexia SR 50mg tabsDE/H/2020/005 Ireland 1189/007/005 Palexia SR 100mg prolonged-release tablets 21727/0042 Palexia SR 100mg tabsDE/H/2020/006 Ireland 1189/007/006 Palexia SR 150mg prolonged-release tablets 21727/0043 Palexia SR 150mg tabsDE/H/2020/007 Ireland 1189/007/007 Palexia SR 200mg prolonged-release tablets 21727/0044 Palexia SR 200mg tabsDE/H/2020/008 Ireland 1189/007/008 Palexia SR 250mg prolonged-release tablets 21727/0045 Palexia SR 250mg tabsDE/H/2020/009 Ireland 1189/007/009 Palexia SR 25mg prolonged-release tablets 21727/0051 Palexia SR 25mg tabsDE/H/5733/001 Ireland 1189/009/001 Versatis 700mg medicated plaster 21727/0016 Versatis 700mg medicated plasterSE/H/0908/001 Ireland 1255/006/001 Jext 150 microgram solution for injection in pre-filled pen 10085/0052 Jext 150mcg PenSE/H/0908/002 Ireland 1255/006/002 Jext 300 microgram solution for injection in pre-filled pen 10085/0053 Jext 300mcg PenNL/H/1458/002 Ireland 1286/1/1 Cozaar Comp 100mg/12.5mg Film-coated Tablets 00025/0473 Cozaar Comp 100mg/12.5mgNL/H/1458/001 Ireland 1286/1/2 Cozaar Comp 50mg/12.5mg Film-coated Tablets 00025/0338 Cozaar Comp 50mg/12.5mgNL/H/1458/003 Ireland 1286/1/3 Cozaar Comp 100mg/25mg Film-coated Tablets 00025/0374 Cozaar Comp 100mg/25mgSE/H/1821/001 Ireland 1286/38/1 Nasonex 50 micrograms/actuation Nasal spray suspension 00025/0587 Nasonex 50ug/actuation nasal sprayNL/H/1457/001 Ireland 1286/4/1 Cozaar 12.5mg film-coated tablets 00025/0515 Cozaar 12.5mg tabsNL/H/1457/002 Ireland 1286/4/2 Cozaar 50mg film-coated tablets 00025/0324 Cozaar 50mg tabsNL/H/1457/003 Ireland 1286/4/3 Cozaar 100mg film-coated tablets 00025/0416 Cozaar 100mg tabsSE/H/0147/001 Ireland 1286/48/1 Cerazette 75 microgram film-coated tablets 00025/0562 Cerazette 75mcg tabsNL/H/0150/001 Ireland 1286/50/1 Implanon NXT implant for subdermal use 00025/0563 NexplanonNL/H/0265/001 Ireland 1286/53/1 NuvaRing 0.120 mg/0.015 mg per 24 hours, vaginal delivery system 00025/0565 NuvaRingDE/H/4019/002 Ireland 13/54/1 Neoral 25mg soft capsules 00101/0387 Neoral 25mg soft capsDE/H/4019/003 Ireland 13/54/2 Neoral 50mg soft capsules 00101/0388 Neoral 50mg soft capsDE/H/4019/004 Ireland 13/54/3 Neoral 100mg soft capsules 00101/0389 Neoral 100mg soft capsDE/H/4019/005 Ireland 13/54/4 Neoral 100mg/ml concentrate for oral solution 00101/0390 Neoral 100mg/ml solution

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductSE/H/0406/003 Ireland 13/79/3 Diovan 80mg film-coated tablets 00101/0600 Diovan 80mg tabsSE/H/0406/004 Ireland 13/79/4 Diovan 160mg film-coated tablets 00101/0601 Diovan 160mg tabsSE/H/0406/005 Ireland 13/79/5 Diovan 40mg film-coated tablets 00101/0599 Diovan 40mg tabsSE/H/0406/006 Ireland 13/79/6 Diovan 320mg film-coated tablets 00101/0726 Diovan 320mg tabsFR/H/0110/001 Ireland 13/80/1 Femara 2.5 mg film-coated tablets 00101/0493 Femara 2.5mg tabsSE/H/0565/001 Ireland 13/91/1 Co-Diovan 80 mg/12.5 mg film-coated tablets 00101/0480 Co-Diovan 80/12.5mg tabsSE/H/0565/002 Ireland 13/91/2 Co-Diovan 160 mg/12.5 mg film-coated tablets 00101/0650 Co-Diovan 160/12.5mg tabsSE/H/0565/003 Ireland 13/91/3 Co-Diovan 160 mg/25 mg film-coated tablets 00101/0651 Co-Diovan 160/25mg tabsDK/H/0168/004 Ireland 13/92/4 Trileptal 60mg/ml suspension 00101/0631 Trileptal 60mg/ml suspensionDE/H/3355/001 Ireland 1332/45/1 Dymista 137 micrograms / 50 micrograms per actuation, Nasal Spray Suspension 15142/0258 Dymista Nasal SprayDK/H/1490/001 Ireland 1380/36/1 Lecalpin 10mg film-coated tablets 00142/1154 Lercanidipine hydrochloride 10mg tabsDK/H/1490/002 Ireland 1380/36/2 Lecalpin 20mg film-coated tablets 00142/1155 Lercanidipine hydrochloride 20mg tabsNL/H/0215/001 Ireland 1410/23/1 Yasmin 0.03mg / 3mg film-coated tablets 00010/0571 YasminDK/H/2888/004 Ireland 1575/001/007 Equasym XL 40mg modified-release capsules, hard 27303/0007 Equasym XL 40mg capsDK/H/2888/005 Ireland 1575/001/008 Equasym XL 50mg modified-release capsules, hard 27303/0008 Equasym XL 50mg capsDK/H/2888/006 Ireland 1575/001/009 Equasym XL 60mg modified-release capsules, hard 27303/0009 Equasym XL 60mg capsDK/H/2888/001 Ireland 1575/1/1 Equasym XL 10mg modified-release capsules, hard 27303/0004 Equasym XL 10mg capsDK/H/2888/002 Ireland 1575/1/2 Equasym XL 20mg modified-release capsules, hard 27303/0005 Equasym XL 20mg capsDK/H/2888/003 Ireland 1575/1/3 Equasym XL 30mg modified-release capsules, hard 27303/0006 Equasym XL 30mg capsDE/H/0384/001 Ireland 1595/1/1 Benetor 10mg flim-coated tablets 08265/0015 Olmetec 10mg tabsDE/H/0384/002 Ireland 1595/1/2 Benetor 20mg flim-coated tablets 08265/0016 Olmetec 20mg tabsDE/H/0384/003 Ireland 1595/1/3 Benetor 40mg flim-coated tablets 08265/0017 Olmetec 40mg tabsDE/H/0523/001 Ireland 1595/2/1 Benetor Plus 20mg/12.5mg flim-coated tablets 08265/0022 Olmetec Plus 20mg/12.5mg tabsDE/H/0523/002 Ireland 1595/2/2 Benetor Plus 20mg/25mg flim-coated tablets 08265/0023 Olmetec Plus 20mg/25mg tabsDE/H/0523/003 Ireland 1595/2/3 Benetor Plus 40mg/12.5mg flim-coated tablets 08265/0029 Olmetec Plus 40mg/12.5mg tabsDE/H/0523/004 Ireland 1595/2/4 Benetor Plus 40mg/25mg flim-coated tablets 08265/0030 Olmetec Plus 40mg/25mg tabsDE/H/2958/001 Ireland 1740/2/1 Atorvastatin Pfizer 10mg Film-coated Tablets 39933/0009 Atorvastatin 10mg tabsDE/H/2958/002 Ireland 1740/2/2 Atorvastatin Pfizer 20mg Film-coated Tablets 39933/0010 Atorvastatin 20mg tabsDE/H/2958/003 Ireland 1740/2/3 Atorvastatin Pfizer 40mg Film-coated Tablets 39933/0011 Atorvastatin 40mg tabsDE/H/2958/004 Ireland 1740/2/4 Atorvastatin Pfizer 80mg film-coated tablets 39933/0012 Atorvastatin 80mg tabsDE/H/3456/001 Ireland 19/44/1 Diflucan 50mg Capsules 00057/0289 Diflucan 50mg capsDE/H/0769/002 Ireland 2/53/2 Capozide tablets 00034/0263 Capozide tabsSE/H/1122/001 Ireland 2010/58/1 Desunin 800IU tablets 46302/0109 Desunin 800IU tabsSE/H/0936/002 Ireland 22/65/5 Efexor XL 75mg prolonged-release capsules, hard 50622/0020 Efexor XL 75mg capsNL/H/3915/002 Ireland 22612/4/1 Durogesic DTrans 25 micrograms/hour Transdermal Patch 00242/0192 Durogesic DTrans 25ug/hrNL/H/3915/003 Ireland 22612/4/2 Durogesic DTrans 50 micrograms/hour Transdermal Patch 00242/0193 Durogesic DTrans 50ug/hrNL/H/3915/004 Ireland 22612/4/3 Durogesic DTrans 75 micrograms/hour Transdermal Patch 00242/0194 Durogesic DTrans 75ug/hrNL/H/3915/005 Ireland 22612/4/4 Durogesic DTrans 100 micrograms/hour Transdermal Patch 00242/0195 Durogesic DTrans 100ug/hrNL/H/3915/001 Ireland 22612/4/5 Durogesic DTrans 12 micrograms/hour Transdermal Patch 00242/0409 Durogesic DTrans 12ug/hrIE/H/0689/001 Ireland 281/80/1 Co-Danthramer 25mg/200mg per 5ml oral suspension 04917/0025 Co-Danthramer 25/200mg per 5ml suspIE/H/0916/001 Ireland 298/17/4 Flucloxacillin GAP 250mg/5ml Oral Solution 30464/0002 Flucloxacillin 250mg/5ml solnFR/H/0228/001 Ireland 320/8/2 Duraphat 5000 ppm Fluoride Toothpaste 00049/0050 Duraphat 5000ppm fluoride toothpasteSE/H/0404/002 Ireland 35/67/1 Innovace 5 tablets 00025/0194 Innovace 5mg tabsDE/H/5724/001 Ireland 405/100/1 Sirdupla 25 microgram/125 microgram per metered dose inhaler 04569/1449 Sirdupla 25/125mcg inhalerDE/H/5724/002 Ireland 405/100/2 Sirdupla 25 microgram/250 microgram per metered dose inhaler 04569/1450 Sirdupla 25/250mcg inhalerDE/H/4690/002 Ireland 540/82/2 Triapin 5mg/5mg prolonged release tablets 04425/0320 Triapin 5mg/5mg PR tabsAT/H/0754/002 Ireland 540/97/2 Clexane Forte 15,000IU (150mg)/1mL Solution for Injection in pre-filled syringes 04425/0185 Clexane Forte 15000IU (150mg)/1mlAT/H/0754/001 Ireland 540/97/8 Clexane Forte 12,000IU (120mg)/0.8mL Solution for Injection in pre-filled syringes 04425/0185 Clexane Forte 12000IU (120mg)/0.8ml

Version: 11/11/2020 Page: 31 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductFR/H/0171/001 Ireland 568/13/1 Diamicron MR 30mg Tablets 05815/0019 Diamicron 30mg MR tabsNL/H/0732/001 Ireland 689/4/1 Mezavant 1200mg gastro-resistant, prolonged release tablets 08081/0040 Mezavant XL 1200mg tabsIT/H/0744/002 Ireland 748/52/2 Lyrinel XL 10mg prolonged release tablets 00242/0386 Lyrinel XL 10mg tabsIE/H/0838/001 Ireland 748/9/1 Sporanox 10mg/ml oral solution 00242/0307 Sporanox LiquidDE/H/1913/001 Ireland 749/115/1 Lercanidipine Teva 10mg film-coated tablets 00289/1283 Lercanidipine hydrochloride 10mg tabsDE/H/1913/002 Ireland 749/115/2 Lercanidipine Teva 20mg film-coated tablets 00289/1284 Lercanidipine hydrochloride 20mg tabsBG/H/0132/001 Ireland 749/183/1 Lercanidipine Teva Pharma 10mg Film-coated Tablets 00289/1439 Lercanidipine hydrochloride 20mg tabsBG/H/0132/002 Ireland 749/183/2 Lercanidipine Teva Pharma 20mg Film-coated Tablets 00289/1439 Lercanidipine hydrochloride 20mg tabsNL/H/0299/001 Ireland 775/2/1 Spiriva 18 microgram, inhalation powder, hard capsule 14598/0062 Spiriva 18mcg inhalation powderNL/H/0718/001 Ireland 775/2/2 Spiriva Respimat 2.5 microgram, inhalation solution 14598/0084 Spiriva RespimatSE/H/0249/001 Ireland 822/139/1 Xalacom 50 micrograms/ml + 5 mg/ml eye drops, solution 00057/1056 Xalacom eye dropsDE/H/6157/001 Ireland 822/140/1 Xalatan 0.005% eye drops, solution 00057/1057 Xalatan eye dropsAT/H/0983/001 Ireland 822/2/1 Aricept 5mg film-coated tablets 10555/0006 Aricept 5mg tabsAT/H/0983/002 Ireland 822/2/2 Aricept 10mg film-coated tablets 10555/0007 Aricept 10mg tabsDE/H/2915/001 Ireland 822/64/1 Latanoprost Pfizer 50 Micrograms/ml eye drops, solution 00057/1221 Latanoprost Pfizer 50ug/ml eye dropsNL/H/0102/001 Ireland 865/10/1 Hypoloc 5mg Tablets 16239/0019 Hypoloc 5mg tabsNL/H/0103/001 Ireland 865/5/1 Nebilet 5mg Tablets 16239/0013 Nebilet 5mg tabsDK/H/0134/003 Ireland 879/5/3 Cosopt Multi preservative-free 20mg/ml+5mg/ml eye drops, solution 16058/0025 Cosopt iMultiDE/H/0299/001 Ireland 891/3/1 Xyzal 5mg film-coated tablet 00039/0539 Xyzal 5mg tabsIE/H/0209/001 Ireland 891/8/2 Zirtek 10mg film-coated tablets 00039/0542 Zirtek Alergy 10mg tabsNL/H/0156/001 Ireland 970/18/1 Seroquel 25mg film-coated tablet 50827/0002 Seroquel 25mg tabsNL/H/0156/010 Ireland 970/18/10 Seroquel XR 300mg prolonged release tablet 50827/0009 Seroquel XL 300mg tabsNL/H/0156/011 Ireland 970/18/11 Seroquel XR 400mg prolonged release tablet 50827/0010 Seroquel XL 400mg tabsNL/H/0156/012 Ireland 970/18/12 Seroquel XR 150mg prolonged release tablet 50827/0007 Seroquel XL 150mg tabsNL/H/0156/002 Ireland 970/18/2 Seroquel 100mg film-coated tablet 50827/0003 Seroquel 100mg tabsNL/H/0156/003 Ireland 970/18/3 Seroquel 200mg film-coated tablet 50827/0004 Seroquel 200mg tabsNL/H/0156/007 Ireland 970/18/7 Seroquel 300mg film-coated tablet 50827/0005 Seroquel 300mg tabsNL/H/0156/008 Ireland 970/18/8 Seroquel XR 50mg prolonged release tablet 50827/0006 Seroquel XL 50mg tabsNL/H/0156/009 Ireland 970/18/9 Seroquel XR 200mg prolonged release tablet 50827/0008 Seroquel XL 200mg tabsSE/H/0230/001 Ireland 970/28/1 Symbicort Turbohaler 100 micrograms/6 micrograms/inhalation, inhalation powder 17901/0091 Symbicort 100/6 TurbohalerSE/H/0229/001 Ireland 970/28/2 Symbicort Turbohaler 200 micrograms/6 micrograms/inhalation, inhalation powder 17901/0092 Symbicort 200/6 TurbohalerSE/H/0229/002 Ireland 970/28/3 Symbicort Turbohaler 400 micrograms/12 micrograms/inhalation, inhalation powder 17901/0200 Symbicort 400/12 TurbohalerNL/H/0343/001 Ireland 970/57/1 Crestor 10mg Film Coated Tablets 17901/0201 Crestor 10mg tabsNL/H/0343/002 Ireland 970/57/2 Crestor 20mg film-coated tabs 17901/0202 Crestor 20mg tabsNL/H/0343/003 Ireland 970/57/3 Crestor 40mg film-coated tabs 17901/0203 Crestor 40mg tabsNL/H/0343/004 Ireland 970/57/4 Crestor 5mg film-coated tabs 17901/0243 Crestor 5mg tabsSE/H/0225/001 Italy 024574105 Zaditen 0,25 mg/ml collirio soluzione 20162/0019 Zaditen 0.25mg/ml eye dropsSE/H/0404/004 Italy 025682028 Enapren 20mg compresse 00025/0196 Innovace 20mg tabsSE/H/0404/002 Italy 025682042 Enapren 5mg compresse 00025/0194 Innovace 5mg tabsFR/H/0645/002 Italy 025707035 Humulin I 100IU/ml isofano sospensione iniettabile 00006/0666 Humulin I 100IU/ml suspension in vialFR/H/0645/003 Italy 025707187 Humulin 30/70 sospensione iniettabile 00006/0667 Humulin M3 100IU/ml suspension in vialDE/H/0769/002 Italy 026067013 Aceplus 50mg+25mg compresse 00034/0263 Capozide tabsDE/H/0769/002 Italy 026067025 Aceplus 50mg+25mg compresse 00034/0263 Capozide tabsPT/H/2363/001 Italy 026089122 Augmentin bambini 400 mg/57 mg/5 ml polvere per sospensione orale 10592/0070 Augmentin Duo 400/57FR/H/0416/004 Italy 026664084 Ciproxin 250mg/5ml granuli e solvente per sospensione orale 00010/0211 Ciproxin 250mg/5ml suspensionNL/H/2081/003 Italy 026804056 Losec 40mg capsule rigide gastroresistenti 17901/0134 Losec 40mg capsNL/H/2081/001 Italy 026804082 Losec 10mg capsule rigide gastroresistenti 17901/0132 Losec 10mg capsNL/H/2081/001 Italy 026804094 Losec 10mg capsule rigide gastroresistenti 17901/0132 Losec 10mg caps

Version: 11/11/2020 Page: 32 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductIE/H/0638/001 Italy 027428010 Norvasc 5mg compresse 50622/0033 Istin 5mg tabsIE/H/0638/002 Italy 027428022 Norvasc 10mg compresse 50622/0031 Istin 10mg tabsFI/H/0139/001 Italy 027443011 Sabril 500mg tablets 04425/0171 Sabril 500mg tabsFI/H/0139/002 Italy 027443047 Sabril 500mg granulato per soluzione ora 04425/0170 Sabril 0.5g sachetsNL/H/1539/003 Italy 027807054 Lamictal 25 mg compresse dispersibili 00003/0347 Lamictal 25mg dispersible tabsNL/H/1539/002 Italy 027807066 Lamictal 5 mg compresse dispersibili 00003/0346 Lamictal 5mg dispersible tabsNL/H/1539/005 Italy 027807078 Lamictal 100 mg compresse dispersibili 00003/0348 Lamictal 100mg dispersible tabsNL/H/1539/004 Italy 027807080 Lamictal 50 mg compresse dispersibili 00003/0368 Lamictal 50mg dispersible tabsIE/H/0838/001 Italy 027808029 Sporanox 10mg/ml soluzione orale 00242/0307 Sporanox LiquidNL/H/0115/001 Italy 027975123 Imigran 10 Spray Nasale 10949/0260 Imigran 10mg Nasal SprayNL/H/0115/002 Italy 027975135 Imigran 20 Spray Nasale 10949/0261 Imigran 20mg Nasal SprayNL/H/0115/002 Italy 027975147 Imigran 20 Spray Nasale 10949/0261 Imigran 20mg Nasal SprayIE/H/0682/001 Italy 028253045 Daivonex 0,005 % soluzione cutanea 00043/0194 Daivonex Scalp SolnDE/H/0899/001 Italy 028740013 Neurontin 100mg capsule rigide 00057/0535 Neurontin 100mg capsDE/H/2184/003 Italy 028752018 Risperdal 1mg compresse rivestite con film 00242/0186 Risperdal 1mg tabsDE/H/2184/004 Italy 028752020 Risperdal 2mg compresse rivestite con film 00242/0187 Risperdal 2mg tabsDE/H/2184/005 Italy 028752032 Risperdal 3mg compresse rivestite con film 00242/0188 Risperdal 3mg tabsDE/H/2184/006 Italy 028752044 Risperdal 4mg compresse rivestite con film 00242/0189 Risperdal 4mg tabsDE/H/2184/003 Italy 028752057 Risperdal 1mg compresse rivestite con film 00242/0186 Risperdal 1mg tabsDE/H/2184/004 Italy 028752069 Risperdal 2mg compresse rivestite con film 00242/0187 Risperdal 2mg tabsDE/H/2184/005 Italy 028752071 Risperdal 3mg compresse rivestite con film 00242/0188 Risperdal 3mg tabsDE/H/2184/006 Italy 028752083 Risperdal 4mg compresse rivestite con film 00242/0189 Risperdal 4mg tabsDE/H/2184/008 Italy 028752095 Risperdal 1mg/ml gocce orali soluzione 00242/0199 Risperdal 1mg/ml oral solnDE/H/2184/009 Italy 028752222 Risperdal 1mg compresse orodispersibili 00242/0379 Risperdal Quicklet 1mg tabsDE/H/2184/009 Italy 028752234 Risperdal 1mg compresse orodispersibili 00242/0379 Risperdal Quicklet 1mg tabsDE/H/2184/010 Italy 028752246 Risperdal 2mg compresse orodispersibili 00242/0380 Risperdal Quicklet 2mg tabsDE/H/2184/010 Italy 028752259 Risperdal 2mg compresse orodispersibili 00242/0380 Risperdal Quicklet 2mg tabsSE/H/0936/002 Italy 028831055 Efexor 75mg capsule rigide a Rilascio Prolungato 50622/0020 Efexor XL 75mg capsSE/H/0936/003 Italy 028831067 Efexor 150mg capsule rigide a Rilascio Prolungato 00057/1281 Efexor XL 150mg capsAT/H/0870/001 Italy 029052077 FOSAMAX 70 mg compresse 00025/0399 Fosamax Once Weekly 70mg tabsAT/H/0874/001 Italy 029054071 Dronal 70mg compresse 00025/0403 Dronal Once Weekly 70mg tabsDE/H/0116/003 Italy 029163033 Lescol 80mg Compresse A Rilascio Prolungato 00101/0587 Lescol XL 80mg tabsDE/H/5447/002 Italy 029172018 Famvir 250mg compresse rivestite con film 35104/0026 Famvir 250mg tabsDE/H/5447/003 Italy 029172057 Famvir 500mg compresse rivestite con film 35104/0027 Famvir 500mg tabsNL/H/3915/001 Italy 029212115 Durogesic 12 microgrammi/ora cerotto transdermico 00242/0409 Durogesic DTrans 12ug/hrNL/H/3915/002 Italy 029212180 Durogesic 25 microgrammi/ora cerotto transdermico 00242/0192 Durogesic DTrans 25ug/hrNL/H/3915/003 Italy 029212255 Durogesic 50 microgrammi/ora cerotto transdermico 00242/0193 Durogesic DTrans 50ug/hrNL/H/3915/004 Italy 029212329 Durogesic 75 microgrammi/ora cerotto transdermico 00242/0194 Durogesic DTrans 75ug/hrNL/H/3915/005 Italy 029212394 Durogesic 100 microgrammi/ora cerotto transdermico 00242/0195 Durogesic DTrans 100ug/hrFI/H/1029/001 Italy 029316041 Misofenac 75 compresse a rilascio modificato 00057/0932 Arthrotec 75 tabsFI/H/1029/001 Italy 029316054 Misofenac 75 compresse a rilascio modificato 00057/0932 Arthrotec 75 tabsNL/H/1457/002 Italy 029384017 Lortaan 50mg compresse rivestite con film 00025/0324 Cozaar 50mg tabsNL/H/1457/002 Italy 029384029 Lortaan 50mg compresse rivestite con film 00025/0324 Cozaar 50mg tabsNL/H/1457/001 Italy 029384031 Lortaan 12.5mg compresse rivestite con film 00025/0515 Cozaar 12.5mg tabsNL/H/1457/001 Italy 029384031 Lortaan 12.5mg compresse rivestite con film 00025/0515 Cozaar 12.5mg tabsNL/H/1457/003 Italy 029384043 Lortaan 100mg compresse rivestite con film 00025/0416 Cozaar 100mg tabsDE/H/4019/002 Italy 029453014 Sandimmun Neoral 25mg capsule molli 00101/0387 Neoral 25mg soft capsDE/H/4019/003 Italy 029453026 Sandimmun Neoral 50mg capsule molli 00101/0388 Neoral 50mg soft caps

Version: 11/11/2020 Page: 33 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductDE/H/4019/004 Italy 029453038 Sandimmun Neoral 100mg capsule molli 00101/0389 Neoral 100mg soft capsDE/H/4019/005 Italy 029453040 Sandimmun Neoral 100mg/ml soluzione orale 00101/0390 Neoral 100mg/ml solutionDE/H/4019/001 Italy 029453053 Sandimmun Neoral 10mg capsule molli 00101/0483 Neoral 10mg soft capsIE/H/0165/002 Italy 029485012 Prograf 1mg capsule rigide 00166/0203 Prograf 1mg hard capsIE/H/0165/003 Italy 029485048 Prograf 5mg capsule rigide 00166/0204 Prograf 5mg hard capsIE/H/0165/003 Italy 029485051 Prograf 5mg capsule rigide 00166/0204 Prograf 5mg hard capsIE/H/0165/003 Italy 029485063 Prograf 5mg capsule rigide 00166/0204 Prograf 5mg hard capsIE/H/0165/002 Italy 029485075 Prograf 1mg capsule rigide 00166/0203 Prograf 1mg hard capsIE/H/0165/002 Italy 029485087 Prograf 1mg capsule rigide 00166/0203 Prograf 1mg hard capsIE/H/0165/001 Italy 029485099 Prograf 0.5mg capsule rigide 00166/0206 Prograf 0.5mg hard capsIE/H/0165/001 Italy 029485101 Prograf 0.5mg capsule rigide 00166/0206 Prograf 0.5mg hard capsIE/H/0165/001 Italy 029485113 Prograf 0.5mg capsule rigide 00166/0206 Prograf 0.5mg hard capsDE/H/5646/001 Italy 029561139 Caverject 10 microgrammi Polvere e solvente, doppia camera, per soluzione iniettabile00057/0939 Caverject DCS 10ugDE/H/5646/002 Italy 029561141 Caverject 20 microgrammi Polvere e solvente, doppia camera, per soluzione iniettabile00057/0940 Caverject DCS 20ugDK/H/2848/001 Italy 029823010 Iopidine 5mg/ml collirio, soluzione 00101/0996 Iopidine 5mg/ml eye dropsAT/H/0904/001 Italy 031809015 Arimidex 1mg 17901/0002 Arimidex 1mg tabsFR/H/0070/001 Italy 031848017 Trusopt 20mg/ml collirio, soluzione 16058/0014 Trusopt Eye DropsSE/H/0110/002 Italy 032023020 Topamax 50mg compresse rivestite con film 00242/0302 Topamax 50mg tabsSE/H/0110/003 Italy 032023032 Topamax 100mg compresse rivestite con film 00242/0303 Topamax 100mg tabsSE/H/0110/004 Italy 032023044 Topamax 200mg compresse rivestite con film 00242/0304 Topamax 200mg tabsSE/H/0110/001 Italy 032023071 Topamax 25mg compresse rivestite con film 00242/0301 Topamax 25mg tabsSE/H/0110/007 Italy 032023083 Topamax 15mg capsule rigide 00242/0348 Topamax Sprinkle 15mg capsSE/H/0110/008 Italy 032023095 Topamax 25mg capsule rigide 00242/0349 Topamax Sprinkle 25mg capsSE/H/0110/008 Italy 032023107 Topamax 50mg capsule rigide 00242/0350 Topamax Sprinkle 50mg capsNL/H/1458/001 Italy 032079028 Hizaar 50mg+12.5mg compresse rivestite con film 00025/0338 Cozaar Comp 50mg/12.5mgNL/H/1458/003 Italy 032079030 Hizaar 100mg+25mg compresse rivestite con film 00025/0374 Cozaar Comp 100mg/25mgNL/H/1458/003 Italy 032079042 Hizaar 100mg+25mg compresse rivestite con film 00025/0374 Cozaar Comp 100mg/25mgNL/H/1458/001 Italy 032079055 Hizaar 50mg+12.5mg compresse rivestite con film 00025/0338 Cozaar Comp 50mg/12.5mgNL/H/0102/001 Italy 032209013 Nebilox 5mg compresse 16239/0019 Hypoloc 5mg tabsNL/H/0103/001 Italy 032210015 Lobivon 5mg compresse 16239/0013 Nebilet 5mg tabsNL/H/0156/001 Italy 032944011 Seroquel 25mg compresse rivestite con film 50827/0002 Seroquel 25mg tabsNL/H/0156/002 Italy 032944023 Seroquel 100mg compresse rivestite con film 50827/0003 Seroquel 100mg tabsNL/H/0156/002 Italy 032944035 Seroquel 100mg compresse rivestite con film 50827/0003 Seroquel 100mg tabsNL/H/0156/003 Italy 032944047 Seroquel 200mg compresse rivestite con film 50827/0004 Seroquel 200mg tabsNL/H/0156/003 Italy 032944050 Seroquel 200mg compresse rivestite con film 50827/0004 Seroquel 200mg tabsNL/H/0156/007 Italy 032944098 Seroquel 300mg compresse rivestite con film 50827/0005 Seroquel 300mg tabsNL/H/0156/007 Italy 032944100 Seroquel 300mg compresse rivestite con film 50827/0005 Seroquel 300mg tabsNL/H/0156/001 Italy 032944112 Seroquel 25mg compresse rivestite con film 50827/0002 Seroquel 25mg tabsNL/H/0156/008 Italy 032944124 Seroquel 50mg compresse a rilasco prolungato 50827/0006 Seroquel XL 50mg tabsNL/H/0156/009 Italy 032944136 Seroquel 200mg compresse a rilasco prolungato 50827/0008 Seroquel XL 200mg tabsNL/H/0156/010 Italy 032944148 Seroquel 300mg compresse a rilasco prolungato 50827/0009 Seroquel XL 300mg tabsNL/H/0156/011 Italy 032944151 Seroquel 400mg compresse a rilasco prolungato 50827/0010 Seroquel XL 400mg tabsNL/H/0156/012 Italy 032944163 Seroquel 150mg compresse a rilasco prolungato 50827/0007 Seroquel XL 150mg tabsDK/H/0105/002 Italy 032991034 Sandrena 1.0mg gel 27925/0016 Sandrena 1mg GelSE/H/0406/003 Italy 033178094 Tareg 80mg compresse rivestite con film 00101/0600 Diovan 80mg tabsSE/H/0406/003 Italy 033178106 Tareg 80mg compresse rivestite con film 00101/0600 Diovan 80mg tabsSE/H/0406/003 Italy 033178118 Tareg 80mg compresse rivestite con film 00101/0600 Diovan 80mg tabsSE/H/0406/003 Italy 033178120 Tareg 80mg compresse rivestite con film 00101/0600 Diovan 80mg tabs

Version: 11/11/2020 Page: 34 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductSE/H/0406/004 Italy 033178144 Tareg 160mg compresse rivestite con film 00101/0601 Diovan 160mg tabsSE/H/0406/004 Italy 033178157 Tareg 160mg compresse rivestite con film 00101/0601 Diovan 160mg tabsSE/H/0406/004 Italy 033178169 Tareg 160mg compresse rivestite con film 00101/0601 Diovan 160mg tabsSE/H/0406/004 Italy 033178171 Tareg 160mg compresse rivestite con film 00101/0601 Diovan 160mg tabsSE/H/0406/005 Italy 033178195 Tareg 40mg compresse rivestite con film 00101/0599 Diovan 40mg tabsSE/H/0406/005 Italy 033178207 Tareg 40mg compresse rivestite con film 00101/0599 Diovan 40mg tabsSE/H/0406/005 Italy 033178486 Tareg 40mg compresse rivestite con film 00101/0599 Diovan 40mg tabsSE/H/0406/005 Italy 033178512 Tareg 40mg compresse rivestite con film 00101/0599 Diovan 40mg tabsDE/H/6157/001 Italy 033219015 Xalatan Eye Drops 0.005%W/V 00057/1057 Xalatan eye dropsNL/H/4790/001 Italy 033224027 Zanedip 10mg compresse rivestite con film 04595/0005 Zanidip 10mg tabsNL/H/4790/002 Italy 033224080 Zanedip 20mg compresse rivestite con film 04595/0010 Zanidip 20mg tabsFR/H/0110/001 Italy 033242013 Femara 2.5mg compresse rivestite con film 00101/0493 Femara 2.5mg tabsAT/H/0983/001 Italy 033254018 Aricept 5mg compresse rivestite con film 10555/0006 Aricept 5mg tabsAT/H/0983/002 Italy 033254020 Aricept 10mg compresse rivestite con film 10555/0007 Aricept 10mg tabsAT/H/0983/003 Italy 033254208 Aricept 5mg compresse orodispersibili 10555/0019 Aricept Evess 5mg oprodispersible tabsAT/H/0983/003 Italy 033254210 Aricept 5mg compresse orodispersibili 10555/0019 Aricept Evess 5mg oprodispersible tabsAT/H/0983/003 Italy 033254246 Aricept 5mg compresse orodispersibili 10555/0019 Aricept Evess 5mg oprodispersible tabsAT/H/0983/004 Italy 033254297 Aricept 10mg compresse orodispersibili 10555/0020 Aricept Evess 10mg orodispersible tabsAT/H/0983/004 Italy 033254309 Aricept 10mg compresse orodispersibili 10555/0020 Aricept Evess 10mg orodispersible tabsAT/H/0983/004 Italy 033254335 Aricept 10mg compresse orodispersibili 10555/0020 Aricept Evess 10mg orodispersible tabsDE/H/6220/001 Italy 033299013 Malarone 250 mg/100 mg compresse rivestite con film 10949/0258 Malarone tabsDE/H/6220/002 Italy 033299037 Malarone Bambini Compresse rivestite con film 10949/0363 Malarone Paediatric tabsSE/H/0121/001 Italy 033312012 Oxis Turbohaler 4.5 microgrammi/dose, polvere per inalazione 17901/0154 Oxis Turbohaler 6SE/H/0121/002 Italy 033312024 Oxis Turbohaler 9 microgrammi/dose, polvere per inalazione 17901/0153 Oxis Turbohaler 12SE/H/1821/001 Italy 033330010 Nasonex 50 microgrammi/erogazione, spray nasale, sospensione 00025/0587 Nasonex 50ug/actuation nasal spraySE/H/1821/001 Italy 033330022 Nasonex 50 microgrammi/erogazione, spray nasale, sospensione 00025/0587 Nasonex 50ug/actuation nasal spraySE/H/1848/001 Italy 033632011 Edronax 4mg compresse 00057/0972 Edronax 4mg tabsSE/H/1848/001 Italy 033632023 Edronax 4mg compresse 00057/0972 Edronax 4mg tabsNL/H/2280/001 Italy 033639081 Femoston 1/5 Conti compresse rivestite con film 46302/0038 Femoston-Conti 1mg/5mg tabsFI/H/0104/003 Italy 034001053 Singulair 4 mg compresse masticabili 00025/0412 Singulair Paediatric 4mg tabsDE/H/4690/002 Italy 034095036 Triapin 5mg/5mg compresse a rilascio prolungato 04425/0320 Triapin 5mg/5mg PR tabsDE/H/4690/002 Italy 034095048 Triapin 5mg/5mg compresse a rilascio prolungato 04425/0320 Triapin 5mg/5mg PR tabsSE/H/0565/001 Italy 034114013 Cotareg 80mg/12.5mg compresse rivestite con film 00101/0480 Co-Diovan 80/12.5mg tabsSE/H/0565/001 Italy 034114025 Cotareg 80mg/12.5mg compresse rivestite con film 00101/0480 Co-Diovan 80/12.5mg tabsSE/H/0565/002 Italy 034114064 Cotareg 160mg/12.5mg compresse rivestite con film 00101/0650 Co-Diovan 160/12.5mg tabsSE/H/0565/002 Italy 034114076 Cotareg 160mg/12.5mg compresse rivestite con film 00101/0650 Co-Diovan 160/12.5mg tabsSE/H/0565/002 Italy 034114088 Cotareg 160mg/12.5mg compresse rivestite con film 00101/0650 Co-Diovan 160/12.5mg tabsSE/H/0565/003 Italy 034114138 Cotareg 160mg/25mg compresse rivestite con film 00101/0651 Co-Diovan 160/25mg tabsSE/H/0565/003 Italy 034114140 Cotareg 160mg/25mg compresse rivestite con film 00101/0651 Co-Diovan 160/25mg tabsSE/H/0565/003 Italy 034114153 Cotareg 160mg/25mg compresse rivestite con film 00101/0651 Co-Diovan 160/25mg tabsNL/H/0144/001 Italy 034115016 Maxalt 5mg compresse 00025/0369 Maxalt 5mg tabsNL/H/0144/001 Italy 034115028 Maxalt 5mg compresse 00025/0369 Maxalt 5mg tabsNL/H/0144/002 Italy 034115042 Maxalt 10mg compresse 00025/0370 Maxalt 10mg tabsNL/H/0144/002 Italy 034115055 Maxalt 10mg compresse 00025/0370 Maxalt 10mg tabsNL/H/0144/004 Italy 034115105 Maxalt RPD 10mg liofilizzato orale 00025/0372 Maxalt Melt 10mgSE/H/0147/001 Italy 034118012 Cerazette 75 microgrammi compresse rivestite con film 00025/0562 Cerazette 75mcg tabsSE/H/0147/001 Italy 034118024 Cerazette 75 microgrammi compresse rivestite con film 00025/0562 Cerazette 75mcg tabsSE/H/0147/001 Italy 034118036 Cerazette 75 microgrammi compresse rivestite con film 00025/0562 Cerazette 75mcg tabs

Version: 11/11/2020 Page: 35 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductDK/H/2978/001 Italy 034226011 Bettamousse 1 mg/g (0,1%) schiuma cutanea 36301/0036 BettamousseDK/H/0134/001 Italy 034242014 Cosopt 20mg/ml+5mg/ml collirio, soluzione 16058/0016 Cosopt solutionDK/H/0134/003 Italy 034242077 Cosopt senza conservante 20mg/ml + 5mg/ml collirio, soluzione 16058/0025 Cosopt iMultiDK/H/0134/001 Italy 034242103 Cosopt 20mg/ml+5mg/ml collirio, soluzione 16058/0016 Cosopt solutionDE/H/5916/001 Italy 034284012 Isotrexin Gel 19494/0068 Isotrexin GelDE/H/5916/001 Italy 034284024 Isotrexin Gel 19494/0068 Isotrexin GelNL/H/1458/003 Italy 034310019 Forzaar 100mg+25mg compresse rivestite con film 00025/0374 Cozaar Comp 100mg/25mgNL/H/1458/003 Italy 034310021 Forzaar 100mg+25mg compresse rivestite con film 00025/0374 Cozaar Comp 100mg/25mgNL/H/0150/001 Italy 034352017 Nexplanon, 68 mg impianto per uso sottocutaneo 00025/0563 NexplanonNL/H/0150/001 Italy 034352029 Nexplanon, 68 mg impianto per uso sottocutaneo 00025/0563 NexplanonSE/H/0169/001 Italy 034371043 Seretide Diskus 50 microgrammi/100 microgrammi/dose di polvere per inalazione in co10949/0314 Seretide 100 AccuhalerSE/H/0169/002 Italy 034371056 Seretide Diskus 50 microgrammi/250 microgrammi/dose di polvere per inalazione in co10949/0315 Seretide 250 AccuhalerSE/H/0169/003 Italy 034371068 Seretide Diskus 50 microgrammi/500 microgrammi/dose di polvere per inalazione in co10949/0316 Seretide 500 AccuhalerDE/H/5770/002 Italy 034371118 Seretide 25 microgrammi/125 microgrammi/dose 10949/0338 Seretide 125 EvohalerDE/H/5770/003 Italy 034371120 Seretide 25 microgrammi/250 microgrammi/dose 10949/0339 Seretide 250 EvohalerDE/H/5771/002 Italy 034463113 Aliflus 25microgrammi/125microgrammi/dose sospensione pressurizzata per inalazione10949/0342 Viani 125 EvohalerDE/H/5771/003 Italy 034463125 Aliflus 25microgrammi/250microgrammi/dose sospensione pressurizzata per inalazione10949/0343 Viani 250 EvohalerSE/H/0192/001 Italy 034568030 Actonel 5mg compresse rivestite con film 20075/1067 Actonel 5mg tabsSE/H/0192/003 Italy 034568105 Actonel 35 mg compresse rivestite con film 10947/0006 Actonel Once-a-week 35mg tabsSE/H/0198/002 Italy 034624460 Celebrex 200mg capsule rigide 50622/0012 Celebrex 200mg capsNL/H/4752/001 Italy 034678033 Aromasin 25mg compresse rivestite 00057/0930 Aromasin 25mg tabsSE/H/0210/006 Italy 034752131 REMINYL 16mg capsule rigide a rilascio prolungato 08557/0053 Reminyl XL 16mg capsSE/H/0210/007 Italy 034752170 Reminyl 24mg capsule rigide a rilascio prolungato 08557/0054 Reminyl XL 24mg capsSE/H/1843/001 Italy 034942019 Zidoval 7,5mg/g Gel vaginale 46302/0153 Zidoval 7.5mg/g Vaginal gelSE/H/0184/005 Italy 034952348 Sequacor 7.5mg 11648/0075 Cardicor 7.5mg tabsSE/H/0211/001 Italy 034972265 Nexium 20mg compresse gastroresistenti 17901/0068 Nexium 20mg tabsSE/H/0211/001 Italy 034972291 Nexium 20mg compresse gastroresistenti 17901/0068 Nexium 20mg tabsSE/H/0211/001 Italy 034972327 Nexium 20mg compresse gastroresistenti 17901/0068 Nexium 20mg tabsSE/H/0211/002 Italy 034972416 Nexium 40mg compresse gastroresisteni 17901/0069 Nexium 40mg tabsSE/H/0211/004 Italy 034972556 Nexium 10 mg Granulato gastroresistente per sospensione orale, in bustina 17901/0253 Nexium 10mg granulesSE/H/0229/001 Italy 035194012 Symbicort, 160 microgrammi/4,5 microgrammi/ inalazione, polvere per inalazione 17901/0092 Symbicort 200/6 TurbohalerSE/H/0229/001 Italy 035194063 Symbicort, 160 microgrammi/4,5 microgrammi/ inalazione, polvere per inalazione 17901/0092 Symbicort 200/6 TurbohalerSE/H/0230/001 Italy 035194113 Symbicort, 80 microgrammi/4,5 microgrammi/ inalazione, polvere per inalazione 17901/0091 Symbicort 100/6 TurbohalerSE/H/0230/001 Italy 035194164 Symbicort, 80 microgrammi/4,5 microgrammi/ inalazione, polvere per inalazione 17901/0091 Symbicort 100/6 TurbohalerSE/H/0229/002 Italy 035194214 Symbicort, 320 microgrammi/9 microgrammi/ inalazione, polvere per inalazione 17901/0200 Symbicort 400/12 TurbohalerIT/H/0712/001 Italy 035297199 Calcitriolo Teva 0.25 mcg capsule 00289/0941 Calcitriol 0.25mcg capsIT/H/0712/002 Italy 035297389 Calcitriolo Teva 0.5 mcg capsule 00289/0942 Calcitriol 0.5mcg capsNL/H/4583/002 Italy 035307305 Relpax 40mg compresse rivestite con film 50622/0054 Relpax 40mg tabsFR/H/0178/001 Italy 035392012 Combiseven 50 microgrammi - 10 microgrammi - 24 o 49876/0011 FemSeven Sequi patchesDE/H/6124/001 Italy 035399017 Actiq 200 microgrammi pastiglia per mucosa orale con applicatore incorporato 14776/0092 Actiq 200mcg lozengeDE/H/6124/001 Italy 035399031 Actiq 200 microgrammi pastiglia per mucosa orale con applicatore incorporato 14776/0092 Actiq 200mcg lozengeDE/H/6124/002 Italy 035399056 Actiq 400 microgrammi pastiglia per mucosa orale con applicatore incorporato 14776/0093 Actiq 400mcg lozengeDE/H/6124/002 Italy 035399070 Actiq 400 microgrammi pastiglia per mucosa orale con applicatore incorporato 14776/0093 Actiq 400mcg lozengeDE/H/6124/003 Italy 035399094 Actiq 600 microgrammi pastiglia per mucosa orale con applicatore incorporato 14776/0094 Actiq 600mcg lozengeDE/H/6124/003 Italy 035399118 Actiq 600 microgrammi pastiglia per mucosa orale con applicatore incorporato 14776/0094 Actiq 600mcg lozengeDE/H/6124/004 Italy 035399132 Actiq 800 microgrammi pastiglia per mucosa orale con applicatore incorporato 14776/0095 Actiq 800mcg lozengeDE/H/6124/004 Italy 035399157 Actiq 800 microgrammi pastiglia per mucosa orale con applicatore incorporato 14776/0095 Actiq 800mcg lozengeDE/H/6124/005 Italy 035399171 Actiq 1200 microgrammi pastiglia per mucosa orale con applicatore incorporato 14776/0096 Actiq 1200mcg lozenge

Version: 11/11/2020 Page: 36 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductDE/H/6124/005 Italy 035399195 Actiq 1200 microgrammi pastiglia per mucosa orale con applicatore incorporato 14776/0096 Actiq 1200mcg lozengeDE/H/6124/006 Italy 035399219 Actiq 1600 microgrammi pastiglia per mucosa orale con applicatore incorporato 14776/0097 Actiq 1600mcg lozengeDE/H/6124/006 Italy 035399233 Actiq 1600 microgrammi pastiglia per mucosa orale con applicatore incorporato 14776/0097 Actiq 1600mcg lozengeSE/H/0249/001 Italy 035402015 Xalacom 50 microgrammi/ml + 5 mg/ml collirio, soluzione 00057/1056 Xalacom eye dropsSE/H/0249/001 Italy 035402027 Xalacom 50 microgrammi/ml + 5 mg/ml collirio, soluzione 00057/1056 Xalacom eye dropsDE/H/0307/001 Italy 035568017 Transtec 35 microgrammi/h Cerotto transdermico 04539/0014 Transtec 35ug/hr patchDE/H/0307/002 Italy 035568043 Transtec 52.5 microgrammi/h Cerotto transdermico 04539/0015 Transtec 52.5ug/hr patchDE/H/0307/003 Italy 035568070 Transtec 70 microgrammi/h Cerotto transdermico 04539/0016 Transtec 70ug/hr patchSE/H/0230/001 Italy 035603012 Symbicort, 80 microgrammi/4,5 microgrammi/ inalazione, polvere per inalazione 17901/0091 Symbicort 100/6 TurbohalerSE/H/0230/001 Italy 035603063 Symbicort, 80 microgrammi/4,5 microgrammi/ inalazione, polvere per inalazione 17901/0091 Symbicort 100/6 TurbohalerDE/H/0299/001 Italy 035666066 Xyzal 5mg compresse rivestite con film 00039/0539 Xyzal 5mg tabsDE/H/0299/001 Italy 035666104 Xyzal 5mg compresse rivestite con film 00039/0539 Xyzal 5mg tabsDE/H/0299/001 Italy 035666116 Xyzal 5mg compresse rivestite con film 00039/0539 Xyzal 5mg tabsNL/H/0299/001 Italy 035668058 Spiriva 18 microgrammi polvere per inalazione, capsula rigida 14598/0062 Spiriva 18mcg inhalation powderDK/H/0279/001 Italy 035675038 Dovobet 50 microgrammi/0.5mg/g unguento 05293/0003 Dovobet ointmentDK/H/0279/001 Italy 035675040 Dovobet 50 microgrammi/0.5mg/g unguento 05293/0003 Dovobet ointmentDK/H/0279/002 Italy 035675141 Dovobet 50microgrammi/g/0.5mg/g gel 05293/0005 Dovobet gelSE/H/0278/002 Italy 035767250 Cipralex 10mg compresse rivestite con film 13761/0009 Cipralex 10mg tabsPT/H/2299/001 Italy 035820012 Arcoxia 60mg compresse rivestite con film 00025/0642 Arcoxia 60mg tabsPT/H/2299/001 Italy 035820024 Arcoxia 60mg compresse rivestite con film 00025/0642 Arcoxia 60mg tabsPT/H/2299/001 Italy 035820036 Arcoxia 60mg compresse rivestite con film 00025/0642 Arcoxia 60mg tabsPT/H/2299/001 Italy 035820048 Arcoxia 60mg compresse rivestite con film 00025/0642 Arcoxia 60mg tabsPT/H/2299/001 Italy 035820051 Arcoxia 60mg compresse rivestite con film 00025/0642 Arcoxia 60mg tabsPT/H/2299/001 Italy 035820063 Arcoxia 60mg compresse rivestite con film 00025/0642 Arcoxia 60mg tabsPT/H/2299/001 Italy 035820075 Arcoxia 60mg compresse rivestite con film 00025/0642 Arcoxia 60mg tabsPT/H/2299/001 Italy 035820087 Arcoxia 60mg compresse rivestite con film 00025/0642 Arcoxia 60mg tabsPT/H/2299/001 Italy 035820099 Arcoxia 60mg compresse rivestite con film 00025/0642 Arcoxia 60mg tabsPT/H/2299/001 Italy 035820101 Arcoxia 60mg compresse rivestite con film 00025/0642 Arcoxia 60mg tabsPT/H/2299/001 Italy 035820113 Arcoxia 60mg compresse rivestite con film 00025/0642 Arcoxia 60mg tabsPT/H/2299/001 Italy 035820125 Arcoxia 60mg compresse rivestite con film 00025/0642 Arcoxia 60mg tabsPT/H/2299/001 Italy 035820137 Arcoxia 60mg compresse rivestite con film 00025/0642 Arcoxia 60mg tabsPT/H/2299/002 Italy 035820152 Arcoxia 90mg compresse rivestite con film 00025/0643 Arcoxia 90mg tabsPT/H/2299/002 Italy 035820164 Arcoxia 90mg compresse rivestite con film 00025/0643 Arcoxia 90mg tabsPT/H/2299/002 Italy 035820176 Arcoxia 90mg compresse rivestite con film 00025/0643 Arcoxia 90mg tabsPT/H/2299/002 Italy 035820188 Arcoxia 90mg compresse rivestite con film 00025/0643 Arcoxia 90mg tabsPT/H/2299/002 Italy 035820190 Arcoxia 90mg compresse rivestite con film 00025/0643 Arcoxia 90mg tabsPT/H/2299/002 Italy 035820202 Arcoxia 90mg compresse rivestite con film 00025/0643 Arcoxia 90mg tabsPT/H/2299/002 Italy 035820214 Arcoxia 90mg compresse rivestite con film 00025/0643 Arcoxia 90mg tabsPT/H/2299/002 Italy 035820226 Arcoxia 90mg compresse rivestite con film 00025/0643 Arcoxia 90mg tabsPT/H/2299/002 Italy 035820238 Arcoxia 90mg compresse rivestite con film 00025/0643 Arcoxia 90mg tabsPT/H/2299/002 Italy 035820240 Arcoxia 90mg compresse rivestite con film 00025/0643 Arcoxia 90mg tabsPT/H/2299/002 Italy 035820253 Arcoxia 90mg compresse rivestite con film 00025/0643 Arcoxia 90mg tabsPT/H/2299/002 Italy 035820265 Arcoxia 90mg compresse rivestite con film 00025/0643 Arcoxia 90mg tabsPT/H/2299/002 Italy 035820277 Arcoxia 90mg compresse rivestite con film 00025/0643 Arcoxia 90mg tabsPT/H/2299/003 Italy 035820291 Arcoxia 120mg compresse rivestite con film 00025/0644 Arcoxia 120mg tabsPT/H/2299/003 Italy 035820303 Arcoxia 120mg compresse rivestite con film 00025/0644 Arcoxia 120mg tabsPT/H/2299/003 Italy 035820315 Arcoxia 120mg compresse rivestite con film 00025/0644 Arcoxia 120mg tabsPT/H/2299/003 Italy 035820327 Arcoxia 120mg compresse rivestite con film 00025/0644 Arcoxia 120mg tabs

Version: 11/11/2020 Page: 37 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductPT/H/2299/003 Italy 035820339 Arcoxia 120mg compresse rivestite con film 00025/0644 Arcoxia 120mg tabsPT/H/2299/003 Italy 035820341 Arcoxia 120mg compresse rivestite con film 00025/0644 Arcoxia 120mg tabsPT/H/2299/003 Italy 035820354 Arcoxia 120mg compresse rivestite con film 00025/0644 Arcoxia 120mg tabsPT/H/2299/003 Italy 035820366 Arcoxia 120mg compresse rivestite con film 00025/0644 Arcoxia 120mg tabsPT/H/2299/003 Italy 035820378 Arcoxia 120mg compresse rivestite con film 00025/0644 Arcoxia 120mg tabsPT/H/2299/003 Italy 035820380 Arcoxia 120mg compresse rivestite con film 00025/0644 Arcoxia 120mg tabsPT/H/2299/003 Italy 035820392 Arcoxia 120mg compresse rivestite con film 00025/0644 Arcoxia 120mg tabsPT/H/2299/003 Italy 035820404 Arcoxia 120mg compresse rivestite con film 00025/0644 Arcoxia 120mg tabsPT/H/2299/003 Italy 035820416 Arcoxia 120mg compresse rivestite con film 00025/0644 Arcoxia 120mg tabsPT/H/2299/004 Italy 035820430 Arcoxia 30mg compresse rivestite con film 00025/0641 Arcoxia 30mg tabsPT/H/2299/004 Italy 035820442 Arcoxia 30mg compresse rivestite con film 00025/0641 Arcoxia 30mg tabsPT/H/2300/003 Italy 035821077 Algix 60 mg compresse rivestite con film 00025/0425 Auxib 60mg tabsPT/H/2300/003 Italy 035821216 Algix 90 mg compresse rivestite con film 00025/0426 Auxib 90mg tabsNL/H/0343/001 Italy 035885058 Crestor 10mg compresse rivestite con film 17901/0201 Crestor 10mg tabsNL/H/0343/002 Italy 035885209 Crestor 20mg compresse rivestite con film 17901/0202 Crestor 20mg tabsNL/H/0343/003 Italy 035885351 Crestor 40mg compresse rivestite con film 17901/0203 Crestor 40mg tabsNL/H/0343/004 Italy 035885502 Crestor 5mg compresse rivestite con film 17901/0243 Crestor 5mg tabsSE/H/0304/001 Italy 035895010 Avodart 0.5mg capsule molli 19494/0006 Avodart 0.5mg soft capsDE/H/0384/001 Italy 036027011 Olmetec 10mg compresse rivestite con film 08265/0015 Olmetec 10mg tabsDE/H/0384/001 Italy 036027023 Olmetec 10mg compresse rivestite con film 08265/0015 Olmetec 10mg tabsDE/H/0384/002 Italy 036027062 Olmetec 20mg compresse rivestite con film 08265/0016 Olmetec 20mg tabsDE/H/0384/002 Italy 036027074 Olmetec 20mg compresse rivestite con film 08265/0016 Olmetec 20mg tabsDE/H/0384/003 Italy 036027112 Olmetec 40mg compresse rivestite con film 08265/0017 Olmetec 40mg tabsDE/H/0384/003 Italy 036027124 Olmetec 40mg compresse rivestite con film 08265/0017 Olmetec 40mg tabsSE/H/0315/001 Italy 036028013 Relestat 0.5mg/ml collirio, soluzione 05179/0004 RelestatFR/H/0685/001 Italy 036489019 Femity 50 microgrammi + 7 microgrammi/24 ore, cerotto transdermico 49876/0010 FemSeven Conti patchesIT/H/0774/001 Italy 036551048 Lyrinel 5mg compresse a rilascio prolungato 00242/0385 Lyrinel XL 5mg tabsIT/H/0774/001 Italy 036551051 Lyrinel 5mg compresse a rilascio prolungato 00242/0385 Lyrinel XL 5mg tabsIT/H/0744/002 Italy 036551137 Lyrinel 10mg compresse a rilascio prolungato 00242/0386 Lyrinel XL 10mg tabsIT/H/0744/002 Italy 036551149 Lyrinel 10mg compresse a rilascio prolungato 00242/0386 Lyrinel XL 10mg tabsDE/H/0496/002 Italy 036679215 Inegy 10mg/20mg compresse 00025/0610 Inegy 10mg/20mg tabsDE/H/0496/003 Italy 036679367 Inegy 10mg/40mg Compresse 00025/0611 Inegy 10mg/40mg tabsSE/H/1822/001 Italy 036685028 Asmanex 200 microgrammi polvere per inalazione 00025/0588 Asmanex 200mcg TwisthalerDE/H/6015/001 Italy 036925055 Duac 1% + 5% Gel 19494/0075 Duac Once Daily 10+50mg/g GelDE/H/6015/002 Italy 036925093 Duac 10mg/g + 30mg/g Gel 19494/0251 Duac Once Daily 10+30mg/g GelDE/H/6015/002 Italy 036925105 Duac 10mg/g + 30mg/g Gel 19494/0251 Duac Once Daily 10+30mg/g GelFR/H/0272/001 Italy 037003047 Unitrama 100mg compresse a rilascio prolungato 43808/0001 Tradorec XL 100mg tabsFR/H/0272/001 Italy 037003100 Unitrama 100mg compresse a rilascio prolungato 43808/0001 Tradorec XL 100mg tabsFR/H/0272/002 Italy 037003163 Unitrama 200mg compresse a rilascio prolungato 43808/0002 Tradorec XL 200mg tabsFR/H/0272/002 Italy 037003225 Unitrama 200mg compresse a rilascio prolungato 43808/0002 Tradorec XL 200mg tabsFR/H/0272/003 Italy 037003326 Unitrama 300mg compresse a rilascio prolungato 43808/0003 Tradorec XL 300mg tabs

FI/H/0313/001 Italy 037051012 Nebid 1000mg/4ml soluzione iniettabile 00010/0549 Nebido 1000mg/4ml injFI/H/0313/001 Italy 037051024 Nebid 1000mg/4ml soluzione iniettabile 00010/0549 Nebido 1000mg/4ml injDE/H/0523/001 Italy 037110018 Olmegan 20mg/12.5mg compresse rivestite con film 08265/0022 Olmetec Plus 20mg/12.5mg tabsDE/H/0523/001 Italy 037110020 Olmegan 20mg/12.5mg compresse rivestite con film 08265/0022 Olmetec Plus 20mg/12.5mg tabsDE/H/0523/001 Italy 037110044 Olmegan 20mg/12.5mg compresse rivestite con film 08265/0022 Olmetec Plus 20mg/12.5mg tabsDE/H/0523/002 Italy 037110121 Olmegan 20mg/25mg compresse rivestite con film 08265/0023 Olmetec Plus 20mg/25mg tabsDE/H/0523/002 Italy 037110133 Olmegan 20mg/25mg compresse rivestite con film 08265/0023 Olmetec Plus 20mg/25mg tabs

Version: 11/11/2020 Page: 38 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductDE/H/0523/002 Italy 037110158 Olmegan 20mg/25mg compresse rivestite con film 08265/0023 Olmetec Plus 20mg/25mg tabsDE/H/0523/003 Italy 037110234 Olmegan 40mg/12.5mg compresse rivestite con film 08265/0029 Olmetec Plus 40mg/12.5mg tabsDE/H/0523/003 Italy 037110246 Olmegan 40mg/12.5mg compresse rivestite con film 08265/0029 Olmetec Plus 40mg/12.5mg tabsDE/H/0523/003 Italy 037110261 Olmegan 40mg/12.5mg compresse rivestite con film 08265/0029 Olmetec Plus 40mg/12.5mg tabsDE/H/0523/004 Italy 037110350 Olmegan 40mg/25mg compresse rivestite con film 08265/0030 Olmetec Plus 40mg/25mg tabsDE/H/0523/004 Italy 037110362 Olmegan 40mg/25mg compresse rivestite con film 08265/0030 Olmetec Plus 40mg/25mg tabsDE/H/0523/004 Italy 037110386 Olmegan 40mg/25mg compresse rivestite con film 08265/0030 Olmetec Plus 40mg/25mg tabsNL/H/0729/001 Italy 037726015 Calcipotriolo Sandoz Unguento 04416/0700 Calcipotriol ointment 50mcg/gDE/H/0871/001 Italy 037789017 Foster 100mcg/6mcg per erogazione soluzione pressurizzata per inalazione 08829/0156 Fostair 100/6 inhalerDE/H/0871/002 Italy 037789031 Foster 100 microgrammi/6 microgrammi polvere per inalazione 08829/0173 Fostair Nexthaler 100/6SE/H/0581/002 Italy 038316028 Zarelis 75mg compressa a rilascio prolungato 01883/0339 Venlalic XL 75mg tabsSE/H/0581/003 Italy 038316218 Zarelis 150mg compresse a rilascio prolungato 01883/0340 Venlalic XL 150mg tabsSE/H/0581/004 Italy 038316422 Zarelis 225mg compresse a rilascio prolungato 01883/0341 Venlalic XL 225mg tabsSE/H/0581/001 Italy 038316648 Zarelis 37.5mg compressa a rilascio prolungato 01883/0338 Venlalic XL 37.5mg tabsDE/H/0957/003 Italy 038427086 Ropinirolo Mylan generics 1mg compresse rivestite con film 04569/0814 Ropinirole 1mg film-coated tabsBE/H/0135/001 Italy 038504015 Mencevax ACWY 10592/0301 ACWY Vax vaccineDK/H/1405/001 Italy 038767024 Xamiol 50 microgrammi/g/0.5mg/g gel 05293/0006 Xamiol gelNL/H/0718/001 Italy 038880011 Spiriva Respimat 2.5 microgrammi soluzione per inalazione 14598/0084 Spiriva RespimatNL/H/1265/001 Italy 038918013 Calcipotriolo Sandoz BV 0,05 mg/ml solution cutanea 04416/0888 Calcipotriol 50 ug/ml Scalp SolnDE/H/0991/002 Italy 038926034 Saflutan 15 microgrammi/ml collirio, soluzione, contenitore monodose 16058/0017 Saflutan 15ug/ml eye dropsIE/H/0163/001 Italy 039021074 Ipramol 0.5mg / 2.5mg per 2.5ml Soluzione da nebulizzare 00530/0961 Ipramol Steri-Neb 0.5mg/2.5mg per 2.5mlSE/H/0643/001 Italy 039153022 Reumaflex 50 mg/ml soluzione iniettabile, siringa preriempita 11587/0046 Metoject 50mg/ml soln for injSE/H/0643/001 Italy 039153123 Reumaflex 50 mg/ml soluzione iniettabile, siringa preriempita 11587/0046 Metoject 50mg/ml soln for injSE/H/0643/001 Italy 039153224 Reumaflex 50 mg/ml soluzione iniettabile, siringa preriempita 11587/0046 Metoject 50mg/ml soln for injSE/H/0643/001 Italy 039153325 Reumaflex 50 mg/ml soluzione iniettabile, siringa preriempita 11587/0046 Metoject 50mg/ml soln for injSE/H/0643/001 Italy 039153426 Reumaflex 50 mg/ml soluzione iniettabile, siringa preriempita 11587/0046 Metoject 50mg/ml soln for injDE/H/1612/004 Italy 039586045 Targin 5mg/2.5mg compresse a rilascio prolungato 16950/0162 Targinact 5mg/2.5mg tabsDE/H/1612/001 Italy 039586159 Targin 10mg/5mg compresse a rilascio prolungato 16950/0157 Targinact 10mg/5mg tabsDE/H/1612/002 Italy 039586262 Targin 20mg/10mg compresse a rilascio prolungato 16950/0158 Targinact 20mg/10mg tabsDE/H/1612/003 Italy 039586375 Targin 40mg/20mg Compress a rilascio prolungato 16950/0161 Targinact 40mg/20mg tabsDE/H/2251/001 Italy 039913013 Combodart 0,5mg/0,4mg capsule rigide 19494/0046 Combodart 0.5mg/0.4mg capsDE/H/2251/001 Italy 039913025 Combodart 0,5mg/0,4mg capsule rigide 19494/0046 Combodart 0.5mg/0.4mg capsDE/H/2251/001 Italy 039913037 Combodart 0,5mg/0,4mg capsule rigide 19494/0046 Combodart 0.5mg/0.4mg capsDK/H/2871/001 Italy 039961014 Picoprep 03194/0014 PicolaxDK/H/2871/001 Italy 039961026 Picoprep 03194/0014 PicolaxNL/H/1375/001 Italy 039982018 Sumatriptan Sun 6mg/0.5ml soluzione iniettabile 31750/0012 Sumatriptan Sun 6mg/0.5ml injectionNL/H/1957/002 Italy 040078192 Risperidone Aurobindo 1mg compresse rivestite con film 16363/0264 Risperidone 1mg film-coated tabsDE/H/5609/001 Italy 040246011 Binosto 70mg compresse effervescenti 40861/0006 Binosto 70mg effervescent tabsDE/H/5733/001 Italy 040335010 Versatis 700mg cerotto medicato 21727/0016 Versatis 700mg medicated plasterDE/H/5733/001 Italy 040335022 Versatis 700mg cerotto medicato 21727/0016 Versatis 700mg medicated plasterDE/H/5733/001 Italy 040335034 Versatis 700mg cerotto medicato 21727/0016 Versatis 700mg medicated plasterDE/H/5733/001 Italy 040335046 Versatis 700mg cerotto medicato 21727/0016 Versatis 700mg medicated plasterDE/H/5733/001 Italy 040335059 Versatis 700mg cerotto medicato 21727/0016 Versatis 700mg medicated plasterDE/H/2020/004 Italy 040422420 Palexia 50mg compresse a rilascio prolungato 21727/0041 Palexia SR 50mg tabsDE/H/2020/005 Italy 040422545 Palexia 100mg compresse a rilascio prolungato 21727/0042 Palexia SR 100mg tabsDE/H/2020/006 Italy 040422661 Palexia 150mg compresse a rilascio prolungato 21727/0043 Palexia SR 150mg tabsDE/H/2020/007 Italy 040422786 Palexia 200mg compresse a rilascio prolungato 21727/0044 Palexia SR 200mg tabsDE/H/2020/008 Italy 040422901 Palexia 250mg compresse a rilascio prolungato 21727/0045 Palexia SR 250mg tabs

Version: 11/11/2020 Page: 39 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductDE/H/2020/009 Italy 040423838 Palexia 25mg compresse a rilascio prolungato 21727/0051 Palexia SR 25mg tabsDE/H/2915/001 Italy 040431013 Latanoprost Pfizer 50 microgrammi/ml, collirio, soluzione 00057/1221 Latanoprost Pfizer 50ug/ml eye dropsDE/H/2915/001 Italy 040431025 Latanoprost Pfizer 50 microgrammi/ml, collirio, soluzione 00057/1221 Latanoprost Pfizer 50ug/ml eye dropsDE/H/2915/001 Italy 040431037 Latanoprost Pfizer 50 microgrammi/ml, collirio, soluzione 00057/1221 Latanoprost Pfizer 50ug/ml eye dropsSE/H/0908/002 Italy 040585010 Jext 300 microgrammi, soluzione iniettabile in una penna preriempita 10085/0053 Jext 300mcg PenSE/H/0908/001 Italy 040585022 Jext 150 microgrammi, soluzione iniettabile in una penna preriempita 10085/0052 Jext 150mcg PenIE/H/0213/001 Italy 040622033 Bonasol 70mg soluzione orale settimanale 34111/0001 Alendronic Acid 70mg oral solnSE/H/1074/001 Italy 040931014 Latanoprost e Timololo Pfizer 50 microgrammi/ml + 5mg/ml, collirio, soluzione 00057/1322 Latanoprost/Timolol Pfizer 50+5 ug/mlSE/H/1074/001 Italy 040931026 Latanoprost e Timololo Pfizer 50 microgrammi/ml + 5mg/ml, collirio, soluzione 00057/1322 Latanoprost/Timolol Pfizer 50+5 ug/mlSE/H/1074/001 Italy 040931038 Latanoprost e Timololo Pfizer 50 microgrammi/ml + 5mg/ml, collirio, soluzione 00057/1322 Latanoprost/Timolol Pfizer 50+5 ug/mlNL/H/1340/001 Italy 041180062 Adoport 0.5mg capsule rigide 04416/0939 Adoport 0.5mg capsDE/H/2958/004 Italy 041443918 Atorvastatina Pfizer 80mg compresse rivestite con film 39933/0012 Atorvastatin 80mg tabsDE/H/3355/001 Italy 041808015 Dymista 137 microgrammi/50 microgrammi per erogazione Spray nasale, sospensione 15142/0258 Dymista Nasal SprayDE/H/3355/001 Italy 041808039 Dymista 137 microgrammi/50 microgrammi per erogazione Spray nasale, sospensione 15142/0258 Dymista Nasal SprayDK/H/2888/001 Italy 041889039 Equasym 10mg capsule rigide a rilascio modificato 27303/0004 Equasym XL 10mg capsDK/H/2888/001 Italy 041889041 Equasym 10mg capsule rigide a rilascio modificato 27303/0004 Equasym XL 10mg capsDK/H/2888/001 Italy 041889054 Equasym 10mg capsule rigide a rilascio modificato 27303/0004 Equasym XL 10mg capsDK/H/2888/002 Italy 041889092 Equasym 20mg capsule rigide a rilascio modificato 27303/0005 Equasym XL 20mg capsDK/H/2888/002 Italy 041889104 Equasym 20mg capsule rigide a rilascio modificato 27303/0005 Equasym XL 20mg capsDK/H/2888/002 Italy 041889116 Equasym 20mg capsule rigide a rilascio modificato 27303/0005 Equasym XL 20mg capsDK/H/2888/003 Italy 041889142 Equasym 30mg capsule rigide a rilascio modificato 27303/0006 Equasym XL 30mg capsDK/H/2888/003 Italy 041889155 Equasym 30mg capsule rigide a rilascio modificato 27303/0006 Equasym XL 30mg capsDK/H/2888/003 Italy 041889167 Equasym 30mg capsule rigide a rilascio modificato 27303/0006 Equasym XL 30mg capsDK/H/2888/004 Italy 041889179 Equasym 40mg capsule rigide a rilascio modificato 27303/0007 Equasym XL 40mg capsDK/H/2888/004 Italy 041889181 Equasym 40mg capsule rigide a rilascio modificato 27303/0008 Equasym XL 50mg capsDK/H/2888/005 Italy 041889193 Equasym 50mg capsule rigide a rilascio modificato 27303/0008 Equasym XL 50mg capsDK/H/2888/005 Italy 041889205 Equasym 50mg capsule rigide a rilascio modificato 27303/0007 Equasym XL 40mg capsDK/H/2888/006 Italy 041889217 Equasym 60mg capsule rigide a rilascio modificato 27303/0009 Equasym XL 60mg capsDK/H/2888/006 Italy 041889229 Equasym 60mg capsule rigide a rilascio modificato 27303/0009 Equasym XL 60mg capsNL/H/4510/001 Italy 041924046 Tixteller 550mg compresse rivestite con film 48053/0007 Refero 550mg tabsSE/H/1969/001 Italy 042292019 Abriff 50 microgrammi/5 microgrammi per erogazione sospensione pressurizzata 16950/0188 Abriff 50/5 inhalerSE/H/1969/002 Italy 042292021 Abriff 125 microgrammi/5 microgrammi per erogazione sospensione pressurizzata 16950/0189 Abriff 125/5 inhalerSE/H/1969/003 Italy 042292033 Abriff 250 microgrammi/10 microgrammi per erogazione sospensione pressurizzata 16950/0190 Abriff 250/10 inhalerSE/H/1921/001 Italy 042294013 Flutiformo 50 microgrammi/5 microgrammi per erogazione 16950/0167 Flutiform 50mcg/5mcg inhalerSE/H/1921/002 Italy 042294025 Flutiformo 125 microgrammi/5 microgrammi per erogazione 16950/0168 Flutiform 125mcg/5mcg inhalerSE/H/1921/003 Italy 042294037 Flutiformo 250 microgrammi/10 microgrammi per erogazione 16950/0169 Flutiform 250mcg/10mcg inhalerPT/H/2189/001 Italy 042391019 Sintredius 1,0 mg/ml soluzione orale 32162/0001 Prednisolone Dompe 1mg/ml oral solnNL/H/2498/001 Italy 042432017 Striverdi Respimat 2,5 microgrammi, soluzione per inalazione 14598/0093 Striverdi Respimat FR/H/0689/001 Italy 042840013 Estring 7.5mcg-24 ore dispositivo vaginale 00057/1424 Estring 7.5mcg/24hrsES/H/0653/001 Italy 043854025 Braltus 10 microgrammi per dose erogata polvere per inalazione, capsula rigida 00289/1870 Braltus 10mcg inhalation powderDK/H/2478/001 Italy 044207013 Enstilar 50 microgrammi/g + 0,5 mg/g schiuma cutanea 05293/0008 Enstilar 50mcg/g+0.5mg/g foamDE/H/5724/001 Italy 045124017 Serzyl 25 microgrammi/125 microgrammi per dose predosata 04569/1449 Sirdupla 25/125mcg inhalerDE/H/5724/002 Italy 045124029 Serzyl 25 microgrammi/250 microgrammi per dose predosata 04569/1450 Sirdupla 25/250mcg inhalerSE/H/0110/001 Latvia 00-0120 Topamax 25mg apvalkotās tabletes 00242/0301 Topamax 25mg tabsSE/H/0110/002 Latvia 00-0121 Topamax 50mg apvalkotās tabletes 00242/0302 Topamax 50mg tabsSE/H/0110/003 Latvia 00-0122 Topamax 100mg apvalkotās tabletes 00242/0303 Topamax 100mg tabsAT/H/0904/001 Latvia 00-0466 Arimidex 1mg apvalkotās tabletes 17901/0002 Arimidex 1mg tabsSE/H/1821/001 Latvia 00-0820 Nasonex 50 mikrogrami/devā deguna aerosols, suspensija 00025/0587 Nasonex 50ug/actuation nasal spray

Version: 11/11/2020 Page: 40 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductSE/H/0406/005 Latvia 02-0390 Diovan 40mg apvalkotās tabletes 00101/0599 Diovan 40mg tabsSE/H/0406/003 Latvia 02-0391 Diovan 80mg apvalkotās tabletes 00101/0600 Diovan 80mg tabsSE/H/0406/004 Latvia 02-0392 Diovan 160mg apvalkotās tabletes 00101/0601 Diovan 160mg tabsFI/H/0313/001 Latvia 05-0141 Nebido 1000mg/4ml šķīdums injekcijām 00010/0549 Nebido 1000mg/4ml injDE/H/0299/001 Latvia 05-0407 Xyzal 5mg apvalkotās tabletes 00039/0539 Xyzal 5mg tabsDE/H/6220/001 Latvia 06-0013 Malarone 250 mg/100 mg apvalkotās tabletes 10949/0258 Malarone tabsNL/H/0718/001 Latvia 07-0241 Spiriva Respimat 2,5 mikrogrami šķīdums inhalācijām 14598/0084 Spiriva RespimatNL/H/0156/010 Latvia 08-0014 Seroquel XR 300mg ilgstošās darbības tabletes 50827/0009 Seroquel XL 300mg tabsNL/H/0156/011 Latvia 08-0015 Seroquel XR 400mg ilgstošās darbības tabletes 50827/0010 Seroquel XL 400mg tabsDE/H/2251/001 Latvia 10-0254 Combodart 0.5mg/0.4mg hard capsules 19494/0046 Combodart 0.5mg/0.4mg capsDK/H/2871/001 Latvia 10-0298 Picoprep 03194/0014 PicolaxDE/H/2020/004 Latvia 10-0615 Palexia retard 50mg ilgstošās darbības tabletes 21727/0041 Palexia SR 50mg tabsDE/H/2020/005 Latvia 10-0616 Palexia retard 100mg ilgstošās darbības tabletes 21727/0042 Palexia SR 100mg tabsDE/H/2020/006 Latvia 10-0617 Palexia retard 150mg ilgstošās darbības tabletes 21727/0043 Palexia SR 150mg tabsDE/H/2020/007 Latvia 10-0618 Palexia retard 200mg ilgstošās darbības tabletes 21727/0044 Palexia SR 200mg tabsDE/H/2020/008 Latvia 10-0619 Palexia retard 250mg ilgstošās darbības tabletes 21727/0045 Palexia SR 250mg tabsNL/H/0299/001 Latvia 11-0234 Spiriva 18 mikrogrami, inhalācijas pulveris cietās kapsulās 14598/0062 Spiriva 18mcg inhalation powderDK/H/0279/002 Latvia 12-0011 Daivobet 50 mikrogrami/0,5 mg/g gels 05293/0005 Dovobet gelDE/H/2020/009 Latvia 12-0156 Palexia retard 25mg ilgstošās darbības tabletes 21727/0051 Palexia SR 25mg tabsNL/H/0150/001 Latvia 13-0040 Nexplanon 68mg implant 00025/0563 NexplanonDE/H/3355/001 Latvia 13-0044 Dymista 137 mikrogrami/ 50 mikrogrami devā deguna aerosols, suspensija 15142/0258 Dymista Nasal SprayNL/H/3441/001 Latvia 16-0011 Cabemet 50 mikrogrami/0,5 mg/g ziede 04416/1449 Calcipotriol/Betamethasone 50/500ug/g DK/H/0134/003 Latvia 18-0093 Cosopt PF 20mg/5mg/ml acu pilieni, šķīdums 16058/0025 Cosopt iMultiDE/H/0109/001 Latvia 98-0598 Sortis 10mg apvalkotas tabletes 50622/0036 Lipitor 10mg tabsDE/H/0109/002 Latvia 98-0599 Sortis 20mg apvalkotas tabletes 50622/0039 Lipitor 20mg tabsDE/H/0109/003 Latvia 98-0600 Sortis 40mg apvalkotas tabletes 50622/0041 Lipitor 40mg tabsSE/H/0565/001 Lithuania LT/1/01/1235/001 Co-Diovan 80 mg/12,5 mg plėvele dengtos tabletės 00101/0480 Co-Diovan 80/12.5mg tabsSE/H/0565/002 Lithuania LT/1/01/1235/002 Co-Diovan 160 mg/12,5 mg plėvele dengtos tabletės 00101/0650 Co-Diovan 160/12.5mg tabsSE/H/0565/003 Lithuania LT/1/01/1235/003 Co-Diovan 160 mg/25 mg plėvele dengtos tabletės 00101/0651 Co-Diovan 160/25mg tabsSE/H/0406/003 Lithuania LT/1/01/1236/010 Diovan 80mg plėvele dengtos tabletės 00101/0600 Diovan 80mg tabsSE/H/0406/004 Lithuania LT/1/01/1236/011 Diovan 160mg plėvele dengtos tabletės 00101/0601 Diovan 160mg tabsSE/H/0406/005 Lithuania LT/1/01/1236/012 Diovan 40mg plėvele dengtos tabletės 00101/0599 Diovan 40mg tabsSE/H/0406/005 Lithuania LT/1/01/1236/013 Diovan 40mg plėvele dengtos tabletės 00101/0599 Diovan 40mg tabsNL/H/0299/001 Lithuania LT/1/02/1389/001-008 Spiriva 18 mikrogramų inhaliaciniai milteliai (kietosios kapsulės) 14598/0062 Spiriva 18mcg inhalation powderDK/H/0279/001 Lithuania LT/1/02/2709/001-006 Daivobet 50 mikrogramų/0,5mg/g tepalas 05293/0003 Dovobet ointmentDK/H/0279/002 Lithuania LT/1/02/2709/008 Daivobet 50 mikrogrammu/0,5 mg/g gelis 05293/0005 Dovobet gelDE/H/6015/002 Lithuania LT/1/04/0154/010 Duac 10mg/30mg/g gelis 19494/0251 Duac Once Daily 10+30mg/g GelFI/H/0313/001 Lithuania LT/1/05/0222/002 Nebido 1000mg/4ml injekcinis tirpalas 00010/0549 Nebido 1000mg/4ml injDK/H/0001/006 Lithuania LT/1/05/0249/001 Norditropin SimpleXx 10mg/1.5ml injekcinis tirpalas uztaise 03132/0132 Norditropin SimpleXx 10mg/1.5ml cartridgeDK/H/0001/006 Lithuania LT/1/05/0249/001 Norditropin SimpleXx 10mg/1,5ml 03132/0132 Norditropin SimpleXx 10mg/1.5ml cartridgeDE/H/6220/001 Lithuania LT/1/06/0441/001 Malarone 250 mg/100 mg plėvele dengtos tabletės 10949/0258 Malarone tabsSE/H/0304/001 Lithuania LT/1/06/0475/002 Avodart 0.5mg minkstos kapsules 19494/0006 Avodart 0.5mg soft capsDE/H/0299/001 Lithuania LT/1/06/0476/001-018 Xyzal 5mg plėvele dengtos tabletės 00039/0539 Xyzal 5mg tabsNL/H/0506/001 Lithuania LT/1/06/0533/010 Inspra 25mg plevele dengtos tabletes 50622/0028 Inspra 25mg tabsNL/H/0506/002 Lithuania LT/1/06/0533/023 Inspra 50mg plevele dengtos tabletes 50622/0029 Inspra 50mg tabsNL/H/0566/001 Lithuania LT/1/06/0597/006 Seroxat 20 mg plevele dengtos tabletes 10592/0001 Seroxat 20mg tabsNL/H/0156/008 Lithuania LT/1/08/0964/001 Seroquel XR 50mg pailginto atpalaidavimo tabletės 50827/0006 Seroquel XL 50mg tabsNL/H/0156/009 Lithuania LT/1/08/0964/002 Seroquel XR 200mg pailginto atpalaidavimo tabletės 50827/0008 Seroquel XL 200mg tabs

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductNL/H/0156/010 Lithuania LT/1/08/0964/003 Seroquel XR 300mg pailginto atpalaidavimo tabletės 50827/0009 Seroquel XL 300mg tabsNL/H/0156/011 Lithuania LT/1/08/0964/004 Seroquel XR 400mg pailginto atpalaidavimo tabletės 50827/0010 Seroquel XL 400mg tabsNL/H/0156/012 Lithuania LT/1/08/0964/005 Seroquel XR 150mg pailginto atpalaidavimo tabletės 50827/0007 Seroquel XL 150mg tabsNL/H/0156/012 Lithuania LT/1/08/0964/006 Seroquel XR 150mg pailginto atpalaidavimo tabletės 50827/0007 Seroquel XL 150mg tabsDE/H/0991/002 Lithuania LT/1/09/1603/001 Taflotan 15 mikrogramu/ml akiu lasai, tirpalas, vienadozeje talpykleje 16058/0017 Saflutan 15ug/ml eye dropsDE/H/2251/001 Lithuania LT/1/10/2032/002 Combodart 0,5mg/0,4mg kietos kapsulės 19494/0046 Combodart 0.5mg/0.4mg capsDE/H/5733/001 Lithuania LT/1/10/2279/001-005 Versatis 700mg vaistinis pleistras 21727/0016 Versatis 700mg medicated plasterDE/H/2020/004 Lithuania LT/1/10/2342/001-022 Palexia retard 50mg pailginto atpalaidavimo tabletės 21727/0041 Palexia SR 50mg tabsDE/H/2020/005 Lithuania LT/1/10/2342/023-044 Palexia retard 100mg pailginto atpalaidavimo tabletės 21727/0042 Palexia SR 100mg tabsDE/H/2020/006 Lithuania LT/1/10/2342/045-066 Palexia retard 150mg pailginto atpalaidavimo tabletės 21727/0043 Palexia SR 150mg tabsDE/H/2020/007 Lithuania LT/1/10/2342/067-088 Palexia retard 200mg pailginto atpalaidavimo tabletės 21727/0044 Palexia SR 200mg tabsDE/H/2020/008 Lithuania LT/1/10/2342/089-110 Palexia retard 250mg pailginto atpalaidavimo tabletės 21727/0045 Palexia SR 250mg tabsDE/H/2020/009 Lithuania LT/1/10/2342/111-134 Palexia retard 25mg pailginto atpalaidavimo tabletės 21727/0051 Palexia SR 25mg tabsDK/H/2871/001 Lithuania LT/1/11/2549/001 Picoprep 03194/0014 PicolaxIE/H/0757/001 Lithuania LT/1/12/2932/001-4 Topotecan Accord 1 mg/ml koncentratas infuziniam tirpalui 20075/0307 Topotecan 1mg/ml infusionNL/H/0150/001 Lithuania LT/1/13/3199/001 Nexplanon 68 mg implantas 00025/0563 NexplanonNL/H/0150/001 Lithuania LT/1/13/3199/002 Nexplanon 68 mg implantas 00025/0563 NexplanonDE/H/3355/001 Lithuania LT/1/13/3227/001 Dymista 137 mikrogramai/50 mikrogramų/dozėje nosies purškalas (suspensija) 15142/0258 Dymista Nasal SprayDE/H/3355/001 Lithuania LT/1/13/3227/003 Dymista 137 mikrogramai/50 mikrogramų/dozėje nosies purškalas (suspensija) 15142/0258 Dymista Nasal SprayDE/H/5724/001 Lithuania LT/1/16/4018/001 Serkep 25/125 mikrogramu/ dozeje 04569/1449 Sirdupla 25/125mcg inhalerDE/H/5724/002 Lithuania LT/1/16/4018/002 Serkep 25/250 mikrogramu/ dozeje 04569/1450 Sirdupla 25/250mcg inhalerDK/H/2638/001 Lithuania LT/1/17/4127/001 Travoprost-Timolol Mylan 40 microgramu-5 mg-ml akiu lasai 04569/1683 Travoprost/Timolol Mylan eye dropsDK/H/2638/001 Lithuania LT/1/17/4127/002 Travoprost-Timolol Mylan 40 microgramu-5 mg-ml akiu lasai 04569/1683 Travoprost/Timolol Mylan eye dropsDK/H/0134/003 Lithuania LT/1/18/4276/001 Cosopt sine 20mg/5mg/ml akių lašai (tirpalas) 16058/0025 Cosopt iMultiSE/H/0936/002 Lithuania LT/1/2000/1045/005 Efexor XR 75mg pailginto atpalaidavimo kietos kapsulės 50622/0020 Efexor XL 75mg capsSE/H/0936/003 Lithuania LT/1/2000/1045/008 Efexor XR 150mg pailginto atpalaidavimo kietos kapsulės 00057/1281 Efexor XL 150mg capsDE/H/4019/002 Lithuania LT/1/94/1089/001 Sandimmun Neoral 25mg minkštosios kapsulės 00101/0387 Neoral 25mg soft capsDE/H/4019/004 Lithuania LT/1/94/1089/003 Sandimmun Neoral 100mg minkštosios kapsulės 00101/0389 Neoral 100mg soft capsSE/H/1821/001 Lithuania LT/1/97/1731/001 Nasonex 50 mikrogramų/dozėje nosies purškalas, suspensija 00025/0587 Nasonex 50ug/actuation nasal spraySE/H/0110/001 Lithuania LT/1/98/0093/001 Topamax 25 mg plėvele dengtos tabletės 00242/0301 Topamax 25mg tabsSE/H/0110/002 Lithuania LT/1/98/0093/002 Topamax 50 mg plėvele dengtos tabletės 00242/0302 Topamax 50mg tabsSE/H/0110/003 Lithuania LT/1/98/0093/003 Topamax 100mg plėvele dengtos tabletės 00242/0303 Topamax 100mg tabsSE/H/0110/003 Lithuania LT/1/98/0093/004 Topamax 200mg plėvele dengtos tabletės 00242/0304 Topamax 200mg tabsSE/H/0110/001 Lithuania LT/1/98/0093/005 Topamax 25 mg plėvele dengtos tabletės 00242/0301 Topamax 25mg tabsSE/H/0110/002 Lithuania LT/1/98/0093/006 Topamax 50 mg plėvele dengtos tabletės 00242/0302 Topamax 50mg tabsSE/H/0110/003 Lithuania LT/1/98/0093/007 Topamax 100mg plėvele dengtos tabletės 00242/0303 Topamax 100mg tabsSE/H/0110/003 Lithuania LT/1/98/0093/008 Topamax 200mg plėvele dengtos tabletės 00242/0304 Topamax 200mg tabsFI/H/0104/003 Lithuania LT/1/98/0189/006 Singulair 4mg kramtomosios tabletes 00025/0412 Singulair Paediatric 4mg tabsAT/H/0904/001 Lithuania LT/1/98/0223/001 Arimidex 1 mg plėvele dengtos tabletės 17901/0002 Arimidex 1mg tabsNL/H/0156/002 Lithuania LT/1/99/0294/002 Seroquel 100mg plėvele dengtos tabletės 50827/0003 Seroquel 100mg tabsNL/H/0156/003 Lithuania LT/1/99/0294/004 Seroquel 200mg plėvele dengtos tabletės 50827/0004 Seroquel 200mg tabsDE/H/0109/001 Lithuania LT/R/98/5513/004 Sortis 10mg plevele dengtos tabletes 50622/0036 Lipitor 10mg tabsDE/H/0109/002 Lithuania LT/R/98/5514/004 Sortis 20mg plevele dengtos tabletes 50622/0039 Lipitor 20mg tabsSE/H/0404/002 Netherlands 10575 Renitec 5mg tabletten 00025/0194 Innovace 5mg tabsNL/H/2081/002 Netherlands 12438 Losec 20mg, maagsapresistente capsules, hard 17901/0133 Losec 20mg capsNL/H/2081/003 Netherlands 14905 Losec 40mg, maagsapresistente capsules, hard 17901/0134 Losec 40mg capsNL/H/2081/001 Netherlands 16745 Losec 10mg, maagsapresistente capsules, hard 17901/0132 Losec 10mg capsDE/H/4019/002 Netherlands 17495 Neoral 25mg capsules 00101/0387 Neoral 25mg soft caps

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductDE/H/4019/004 Netherlands 17496 Neoral 100mg capsules 00101/0389 Neoral 100mg soft capsDE/H/4019/005 Netherlands 17497 Neoral 100mg/ml drank 00101/0390 Neoral 100mg/ml solutionNL/H/1457/002 Netherlands 17617 Cozaar 50mg filmomhulde tabletten 00025/0324 Cozaar 50mg tabsNL/H/1539/002 Netherlands 19115 Lamictal Dispers 5 mg, dispergeerbare/kauwtabletten 00003/0346 Lamictal 5mg dispersible tabsNL/H/1539/003 Netherlands 19116 Lamictal Dispers 25 mg, dispergeerbare/kauwtabletten 00003/0347 Lamictal 25mg dispersible tabsNL/H/1539/005 Netherlands 19117 Lamictal Dispers 100 mg, dispergeerbare/kauwtabletten 00003/0348 Lamictal 100mg dispersible tabsNL/H/4790/001 Netherlands 20813 Lerdip 10mg filmomhulde tabeltten 04595/0005 Zanidip 10mg tabsNL/H/0156/001 Netherlands 20826 Seroquel 25 filmomhulde tabletten 50827/0002 Seroquel 25mg tabsNL/H/0156/002 Netherlands 20827 Seroquel 100 filmomhulde tabletten 50827/0003 Seroquel 100mg tabsNL/H/0156/003 Netherlands 20828 Seroquel 200 filmomhulde tabletten 50827/0004 Seroquel 200mg tabsNL/H/1539/004 Netherlands 20926 Lamictal Dispers 50 mg, dispergeerbare/kauwtabletten 00003/0368 Lamictal 50mg dispersible tabsIE/H/0838/001 Netherlands 21024 Trisporal O.S.-drank 10mg/ml 00242/0307 Sporanox LiquidSE/H/0121/001 Netherlands 21026 Oxis 12 Turbuhaler 12 microgram per dosis inhalatiepoeder 17901/0154 Oxis Turbohaler 6SE/H/0121/002 Netherlands 21027 Oxis 12 Turbuhaler 12 microgram per dosis inhalatiepoeder 17901/0153 Oxis Turbohaler 12DE/H/6157/001 Netherlands 21304 Xalatan oogdruppels 50 microgram/ml 00057/1057 Xalatan eye dropsSE/H/1821/001 Netherlands 21613 Nasonex, neuspray, suspensie 50 microgram/verstuiving 00025/0587 Nasonex 50ug/actuation nasal sprayNL/H/2081/008 Netherlands 21684 Losec MUPS 20 maagsapresistente tabletten 17901/0138 Losec MUPS 20mg tabsSE/H/0139/001 Netherlands 22148 Detrusitol 1mg filmomhulde tabletten 50622/0015 Detrusitol 1mg tabsSE/H/0139/002 Netherlands 22149 Detrusitol 2mg filmomhulde tabletten 50622/0016 Detrusitol 2mg tabsSE/H/0565/001 Netherlands 22365 Co-Diovan 80/12,5, 80 mg/12,5 mg filmomhulde tabletten 00101/0480 Co-Diovan 80/12.5mg tabsDE/H/0899/002 Netherlands 22482 Neurontin 300mg 50622/0047 Neurontin 300mg capsSE/H/0147/001 Netherlands 22743 Cerazette, 75 microgram filmomhulde tabletten 00025/0562 Cerazette 75mcg tabsSE/H/0169/001 Netherlands 23529 Seretide Diskus 50 microgram/100 microgram/dosis - inhalatiepoeder, voorverdeeld 10949/0314 Seretide 100 AccuhalerSE/H/0169/002 Netherlands 23530 Seretide Diskus 50 microgram/250 microgram/dosis - inhalatiepoeder, voorverdeeld 10949/0315 Seretide 250 AccuhalerSE/H/0169/003 Netherlands 23531 Seretide Diskus 50 microgram/500 microgram/dosis - inhalatiepoeder, voorverdeeld 10949/0316 Seretide 500 AccuhalerNL/H/0215/001 Netherlands 23827 Yasmin filmomhulde tabletten 0,03mg/3 mg 00010/0571 YasminSE/H/0110/004 Netherlands 24168 Topamax 200mg filmomhulde tabletten 00242/0304 Topamax 200mg tabsNL/H/4649/001 Netherlands 24681 Betahistine diHCL Mylan 8mg tabletten 04569/0348 Betahistine diHCl 8mg tabsNL/H/4649/002 Netherlands 24682 Betahistine diHCL Mylan 16mg tabletten 04569/0349 Betahistine diHCl 16mg tabsNL/H/0265/001 Netherlands 25073 Nuvaring 0.120mg/0.015mg per 24 uur hulpmiddel voor vaginaal gebruik 00025/0565 NuvaRingDE/H/6220/001 Netherlands 25386 Malarone 250/100 mg filmomhulde tabletten 10949/0258 Malarone tabsNL/H/0156/007 Netherlands 25603 Seroquel 300 filmomhulde tabletten 50827/0005 Seroquel 300mg tabsSE/H/0225/001 Netherlands 25726 Zaditen 0,25 mg/ml, oogdruppels, oplossing 20162/0019 Zaditen 0.25mg/ml eye dropsNL/H/0132/003 Netherlands 25780 Remeron Soltab 15mg 00025/0546 Zispin 15mg SoltabNL/H/0132/004 Netherlands 25781 Remeron soltab 30mg 00025/0547 Zispin 30mg SoltabDE/H/5770/002 Netherlands 25866 Seretide 25/125 Inhalator CFK-vrij 10949/0338 Seretide 125 EvohalerDE/H/5770/003 Netherlands 25867 Seretide 25/250 Inhalator CFK-vrij 10949/0339 Seretide 250 EvohalerSE/H/0230/001 Netherlands 25886 Symbicort Turbuhaler 100/6 inhalatiepoeder 17901/0091 Symbicort 100/6 TurbohalerSE/H/0229/001 Netherlands 25887 Symbicort Turbuhaler 200/6 inhalatiepoeder 17901/0092 Symbicort 200/6 TurbohalerNL/H/0299/001 Netherlands 26191 Spiriva 18 microgram, inhalatiepoeder in harde capsules 14598/0062 Spiriva 18mcg inhalation powderDE/H/0299/001 Netherlands 26770 Xyzal 5mg filmomhulde tabletten 00039/0539 Xyzal 5mg tabsNL/H/1457/003 Netherlands 26791 Cozaar 100mg filmomhulde tabletten 00025/0416 Cozaar 100mg tabsSE/H/0406/003 Netherlands 26939 Diovan 80mg filmomhulde tabletten 00101/0600 Diovan 80mg tabsSE/H/0406/004 Netherlands 26940 Diovan 160mg filmomhulde tabletten 00101/0601 Diovan 160mg tabsNL/H/4536/001 Netherlands 27118 Buspiron HCl Mylan 10mg, tabletten 04569/0369 Buspirone hydrochloride 10mg tabsDE/H/5715/001 Netherlands 27199 Flecainideacetaat Mylan 50mg tabletten 04569/1095 Flecainide acetate 50mg tabsDE/H/5715/002 Netherlands 27200 Flecainideacetaat Mylan 100mg tabletten 04569/1096 Flecainide acetate 100mg tabsNL/H/0380/001 Netherlands 27505 Angeliq, 1 mg/2 mg filmomhulde tabletten 00010/0518 Angeliq tabs

Version: 11/11/2020 Page: 43 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductNL/H/4742/002 Netherlands 27572 Ofloxacine 400 PCH 14776/0055 Ofloxacin Teva 400mg tabsSE/H/0229/002 Netherlands 27690 Symbicort Turbuhaler 400/12 inhalatiepoeder 17901/0200 Symbicort 400/12 TurbohalerDE/H/6007/001 Netherlands 28073 Concerta 18mg tabletten met verlengde afgifte 00242/0372 Concerta XL 18mg tabsDE/H/6007/002 Netherlands 28074 Concerta 36 mg tabletten met verlengde afgifte 00242/0373 Concerta XL 36mg tabsDE/H/6007/003 Netherlands 28075 Concerta 54mg tabletten met verlengde afgifte 00242/0374 Concerta XL 54mg tabsSE/H/0304/001 Netherlands 28317 Avodart zachte capsules 19494/0006 Avodart 0.5mg soft capsNL/H/4790/002 Netherlands 28644 Lerdip 20mg filmomhulde tabeltten 04595/0010 Zanidip 20mg tabsDE/H/0384/001 Netherlands 28782 Olmetec 10mg filmomhulde tabletten 08265/0015 Olmetec 10mg tabsDE/H/0384/002 Netherlands 28783 Olmetec 20mg filmomhulde tabletten 08265/0016 Olmetec 20mg tabsDE/H/0384/003 Netherlands 28784 Olmetec 40mg filmomhulde tabletten 08265/0017 Olmetec 40mg tabsNL/H/0614/002 Netherlands 28932 Azitromycine 500 PCH filmomhulde tabletten 00289/0585 Azithromycin Teva 500mg tabsNL/H/0487/001 Netherlands 29151 Vesicare 5mg 00166/0197 Vesicare 5mg tabsNL/H/0487/002 Netherlands 29152 Vesicare 10mg 00166/0198 Vesicare 10mg tabsSE/H/0565/002 Netherlands 29491 Co-Diovan 160/12,5, 160 mg/12,5 mg filmomhulde tabletten 00101/0650 Co-Diovan 160/12.5mg tabsFI/H/0313/001 Netherlands 30794 Nebido 1000mg/4ml oplossing voor injectie 00010/0549 Nebido 1000mg/4ml injNL/H/0343/004 Netherlands 30823 Crestor 5, filmomhulde tabletten 5 mg 17901/0243 Crestor 5mg tabsDE/H/0496/003 Netherlands 30929 Inegy 10/40 tabletten 10mg/40mg 00025/0611 Inegy 10mg/40mg tabsSE/H/0565/003 Netherlands 31122 Co-Diovan 160/25, 160 mg/25 mg filmomhulde tabletten 00101/0651 Co-Diovan 160/25mg tabsDE/H/0528/001 Netherlands 31994 Atimos 12 microgram aerosol 08829/0154 Atimos ModuliteSE/H/0406/005 Netherlands 32137 Diovan 40mg filmomhulde tabletten 00101/0599 Diovan 40mg tabsDE/H/0523/001 Netherlands 32740 Olmetec HCTZ 20mg/12,5mg filmomhulde tabletten 08265/0022 Olmetec Plus 20mg/12.5mg tabsDE/H/0523/002 Netherlands 32741 Olmetec HCTZ 20mg/25mg filmomhulde tabletten 08265/0023 Olmetec Plus 20mg/25mg tabsNL/H/4505/001 Netherlands 33078 Desmopressine Acetaat-Trihydraat 35533/0145 Desmopressin 10mcg sprayDK/H/2888/001 Netherlands 33227 Equasym XL 10mg Capsules met gereguleerde afgifte, hard 27303/0004 Equasym XL 10mg capsDK/H/2888/002 Netherlands 33228 Equasym XL 20mg Capsules met gereguleerde afgifte, hard 27303/0005 Equasym XL 20mg capsDK/H/2888/003 Netherlands 33229 Equasym XL 30mg Capsules met gereguleerde afgifte, hard 27303/0006 Equasym XL 30mg capsNL/H/4513/001 Netherlands 33594 Doxazosine Sandoz retard 4mg 04416/0703 Colixil XL 4mg tabsNL/H/0732/001 Netherlands 33600 Mezavant 1200mg maagsapresistente, tabletten met verlengde afgifte 08081/0040 Mezavant XL 1200mg tabsDK/H/3036/001 Netherlands 33656 Fluticasonpropionaat 50 microgram PCH 00530/0745 Nasofan Nasal SprayDK/H/0134/002 Netherlands 33660 Cosopt Conserveermiddelvrij, oogdruppels, oplossing, 20mg/ml+5mg/ml 16058/0015 Cosopt SDUSE/H/1984/001 Netherlands 33759 Efracea 40mg capsules 10590/0056 Efracea 40mg capsFR/H/0288/001 Netherlands 33801 Timogel 1mg/g 20162/0010 Tiopex 1mg/g eye gel SDUDE/H/0690/001 Netherlands 34024 Medikinet 5mg Tabletten 11243/0002 Medikinet 5mg tabsDE/H/0690/002 Netherlands 34025 Medikinet 10mg Tabletten 11243/0003 Medikinet 10mg tabsDE/H/0690/003 Netherlands 34026 Medikinet 5mg Tabletten 11243/0004 Medikinet 20mg tabsDE/H/0690/004 Netherlands 34027 Medikinet CR 10mg capsules met gereguleerde afgifte, hard 11243/0005 Medikinet XL 10mg capsDE/H/0690/005 Netherlands 34028 Medikinet CR 20mg capsules met gereguleerde afgifte, hard 11243/0006 Medikinet XL 20mg capsDE/H/0690/006 Netherlands 34029 Medikinet CR 30mg capsules met gereguleerde afgifte, hard 11243/0007 Medikinet XL 30mg capsDE/H/0690/007 Netherlands 34030 Medikinet CR 40 mg capsules met gereguleerde afgifte, hard 11243/0008 Medikinet XL 40mg capsNL/H/0855/001 Netherlands 34031 Azyter 15 mg/g 20162/0012 Azyter 15mg/g eye drops SDUNL/H/0718/001 Netherlands 34382 Spiriva Respimat 2,5 microgram tiotropium oplossing voor inhalatie 14598/0084 Spiriva RespimatSE/H/0406/006 Netherlands 34472 Diovan 320mg filmomhulde tabletten 00101/0726 Diovan 320mg tabsDE/H/0871/001 Netherlands 34610 Foster 100/6 microgram/dosis, aërosol, oplossing 08829/0156 Fostair 100/6 inhalerNL/H/0156/008 Netherlands 34625 Seroquel XR 50 mg, tabletten met verlengde afgifte 50827/0006 Seroquel XL 50mg tabsNL/H/0156/009 Netherlands 34626 Seroquel XR 200 mg, tabletten met verlengde afgifte 50827/0008 Seroquel XL 200mg tabsNL/H/0156/010 Netherlands 34627 Seroquel XR 300 mg, tabletten met verlengde afgifte 50827/0009 Seroquel XL 300mg tabsNL/H/0156/011 Netherlands 34628 Seroquel XR 400 mg, tabletten met verlengde afgifte 50827/0010 Seroquel XL 400mg tabsSE/H/0686/001 Netherlands 34979 Sumatriptan Aurobindo 50mg tabletten 16363/0595 Sumatriptan Aurobindo 50mg tabs

Version: 11/11/2020 Page: 44 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductSE/H/0686/002 Netherlands 34980 Sumatriptan Aurobindo 100mg tabletten 16363/0596 Sumatriptan Aurobindo 100mg tabsNL/H/2564/001 Netherlands 55387 Propranolol HCl Accord 10mg filmomhulde tabletten 20075/0360 Propranolol 10mg tabsNL/H/2564/002 Netherlands 55388 Propranolol HCl Accord 40mg filmomhulde tabletten 20075/0361 Propranolol 40mg tabsNL/H/2564/003 Netherlands 55880 Propranolol HCl Accord 80mg filmomhulde tabletten 20075/0362 Propranolol 80mg tabsDE/H/0929/001 Netherlands 100050 OsvaRen 435mg/235mg 29386/0005 OsvaRen 435mg/235mg tabsSE/H/0643/001 Netherlands 100943 Metoject 50 mg/ml, oplossing voor injectie 11587/0046 Metoject 50mg/ml soln for injSE/H/0211/004 Netherlands 101600 Nexium 10 mg Sachet, maagsapresistent granulaat voor orale suspensie 17901/0253 Nexium 10mg granulesNL/H/4734/001 Netherlands 101610 Nebivolol Glenmark 2.5mg tabletten 25258/0002 Nebivolol 2.5mg tabsDE/H/1483/001 Netherlands 101690 Ropinirole Teva 0.25mg 00289/1192 Ropinirole 0.25mg tabsDE/H/6007/004 Netherlands 101739 Concerta 27mg tabletten met verlengde afgifte 00242/0400 Concerta XL 27mg tabsNL/H/1457/001 Netherlands 101836 Cozaar 12.5mg filmomhulde tabletten 00025/0515 Cozaar 12.5mg tabsNL/H/0156/012 Netherlands 102408 Seroquel XR 150 mg, tabletten met verlengde afgifte 50827/0007 Seroquel XL 150mg tabsDK/H/0608/001 Netherlands 103546 Doxazosine Aurobindo Retard 4 mg, tabletten met verlengde afgifte 00142/1184 Raporsin XL 4mg tabsDE/H/1913/001 Netherlands 103614 Lercanidipine HCl 10mg PCH filmomhulde tabletten 00289/1283 Lercanidipine hydrochloride 10mg tabsDE/H/1913/002 Netherlands 103615 Lercanidipine HCl 20mg PCH filmomhulde tabletten 00289/1284 Lercanidipine hydrochloride 20mg tabsDE/H/2251/001 Netherlands 104130 Combodart 0,5mg/0,4mg, harde capsules 19494/0046 Combodart 0.5mg/0.4mg capsDE/H/0523/003 Netherlands 104240 Olmetec HCTZ 40mg/12,5mg filmomhulde tabletten 08265/0029 Olmetec Plus 40mg/12.5mg tabsDE/H/0523/004 Netherlands 104241 Olmetec HCTZ 40mg/25mg filmomhulde tabletten 08265/0030 Olmetec Plus 40mg/25mg tabsDK/H/1729/001 Netherlands 104320 Exemestaan Accord 15mg filmomhulde tabletten 20075/01079 Exemestane Accord 25mg tabsAT/H/0194/002 Netherlands 106297 Natriumrisedronaat Sandoz Wekelijks 35 mg, filmomhulde tabletten 04416/1165 Risedronate sodium 35mg tabsSE/H/0908/001 Netherlands 106307 Jext 150 microgram, oplossing voor injectie 10085/0052 Jext 150mcg PenSE/H/0908/002 Netherlands 106309 Jext 300 microgram, oplossing voor injectie 10085/0053 Jext 300mcg PenNL/H/4556/001 Netherlands 106591 Naratriptan Mylan 2.5mg 04569/1037 Naratriptan 2.5mg tabsDK/H/2871/001 Netherlands 106616 Picoprep 03194/0014 PicolaxNL/H/4781/003 Netherlands 106813 Quetiapine Accord 400mg tabletten met verlengde afgifte 20075/0216 Atrolak XL 400mg tabsNL/H/4199/002 Netherlands 107219 Rizatriptan SmeltTab Mylan 10 mg, orodispergeer bare tabletten 04569/1149 Rizatriptan 10mg orodispersible tabsDE/H/2704/001 Netherlands 107303 Zolmitriptan Mylan 2,5 mg orodispergeerbare tabletten 04569/1156 Zolmitriptan 2.5mg orodispersible tabsBG/H/0132/001 Netherlands 107822 Lercanidipine HCl 10mg Teva filmomhulde tabletten 00289/1438 Lercanidipine hydrochloride 10mg tabsBG/H/0132/002 Netherlands 107825 Lercanidipine HCl 20mg Teva filmomhulde tabletten 00289/1439 Lercanidipine hydrochloride 20mg tabsDE/H/2915/001 Netherlands 107918 Latanoprost Pfizer 50 microgram/ml oogdruppels, oplossing 00057/1221 Latanoprost Pfizer 50ug/ml eye dropsDE/H/2915/001 Netherlands 107918 Latanoprost Pfizer 50 microgram/ml oogdruppels, oplossing 00057/1221 Latanoprost Pfizer 50ug/ml eye dropsNL/H/2038/001 Netherlands 107922 Mometasonfuroaat Sandoz 50 microgram/dosis, neusspray suspensie 04416/1236 Mometasone Furoate 50mcg nasal sprayDE/H/0690/008 Netherlands 108026 Medikinet CR 5mg capsules met gereguleerde afgifte, hard 11243/0010 Medikinet XL 5mg capsDE/H/2958/001 Netherlands 108085 Atorvastatine Pfizer 10mg filmomhulde tabletten 39933/0009 Atorvastatin 10mg tabsDE/H/2958/002 Netherlands 108086 Atorvastatine Pfizer 20mg filmomhulde tabletten 39933/0010 Atorvastatin 20mg tabsDE/H/2958/003 Netherlands 108088 Atorvastatine Pfizer 40mg filmomhulde tabletten 39933/0011 Atorvastatin 40mg tabsDE/H/2958/004 Netherlands 108089 Atorvastatine Pfizer 80mg filmomhulde tabletten 39933/0012 Atorvastatin 80mg tabsDE/H/3012/001 Netherlands 108721 Levothyroxine-natrum 25 micrograms/5ml 00289/1593 Levothyroxine 25mcg/5ml oral solnAT/H/0318/001 Netherlands 108868 Esomeprazol Mylan 20 mg, maagsapresistente capsules, hard 04569/1268 Esomeprazole 20mg capsAT/H/0318/002 Netherlands 108869 Esomeprazol Mylan 40 mg, maagsapresistente capsules, hard 04569/1269 Esomeprazole 40mg capsSE/H/1074/001 Netherlands 109301 Latanoprost/timolol Pfizer 50 microgram/ml + 5 mg/ml oogdruppels, oplossing 00057/1322 Latanoprost/Timolol Pfizer 50+5 ug/mlSE/H/1122/001 Netherlands 109770 Divisun 800 IE tabletten 46302/0109 Desunin 800IU tabsDE/H/0871/002 Netherlands 110104 Foster Nexthaler 100/6 microgram/dosis, inhalatiepoeder 08829/0173 Fostair Nexthaler 100/6DK/H/2888/004 Netherlands 111228 Equasym XL 40mg Capsules met gereguleerde afgifte, hard 27303/0007 Equasym XL 40mg capsDK/H/2888/005 Netherlands 111232 Equasym XL 50mg Capsules met gereguleerde afgifte, hard 27303/0008 Equasym XL 50mg capsDK/H/2888/006 Netherlands 111233 Equasym XL 60mg Capsules met gereguleerde afgifte, hard 27303/0009 Equasym XL 60mg capsDK/H/2028/001 Netherlands 111561 Methylfenidaat HCl Sandoz retard 18mg, tabletten met verlengde afgifte 04416/1346 Matoride XL 18mg tabsDK/H/2028/002 Netherlands 111562 Methylfenidaat HCl Sandoz retard 36mg, tabletten met verlengde afgifte 04416/1348 Matoride XL 36mg tabs

Version: 11/11/2020 Page: 45 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductDK/H/2028/003 Netherlands 111563 Methylfenidaat HCl Sandoz retard 54mg, tabletten met verlengde afgifte 04416/1349 Matoride XL 54mg tabsNL/H/2968/001 Netherlands 111622 Vesomni 6mg-0.4mg filmomhulde 00166/0404 Vesomni 6mg/0.4mg tabsSE/H/0643/002 Netherlands 111962 Metoject PEN 7.5mg=0,15ml oplossing voor injectie in een voorgevulde pen 11587/0076 Metoject Pen 7.5mgSE/H/0643/003 Netherlands 111963 Metoject PEN 10mg=0,2ml oplossing voor injectie in een voorgevulde pen 11587/0077 Metoject Pen 10mgSE/H/0643/004 Netherlands 111964 Metoject PEN 12.5mg=0,25ml oplossing voor injectie in een voorgevulde pen 11587/0078 Metoject Pen 12.5mgSE/H/0643/005 Netherlands 111965 Metoject PEN 15mg=0,3ml oplossing voor injectie in een voorgevulde pen 11587/0079 Metoject Pen 15mgSE/H/0643/006 Netherlands 111966 Metoject PEN 17.5mg=0,35ml oplossing voor injectie in een voorgevulde pen 11587/0080 Metoject Pen 17.5mgSE/H/0643/007 Netherlands 111967 Metoject PEN 20mg=0,4ml oplossing voor injectie in een voorgevulde pen 11587/0081 Metoject Pen 20mgSE/H/0643/008 Netherlands 111968 Metoject PEN 22.5mg=0,45ml oplossing voor injectie in een voorgevulde pen 11587/0082 Metoject Pen 22.5mgSE/H/0643/009 Netherlands 111969 Metoject PEN 25mg=0,5ml oplossing voor injectie in een voorgevulde pen 11587/0083 Metoject Pen 25mgSE/H/0643/010 Netherlands 111970 Metoject PEN 27.5mg=0,55ml oplossing voor injectie in een voorgevulde pen 11587/0084 Metoject Pen 27.5mgSE/H/0643/011 Netherlands 111971 Metoject PEN 30mg=0,6ml oplossing voor injectie in een voorgevulde pen 11587/0085 Metoject Pen 30mgNL/H/3926/001 Netherlands 111974 Fusidinezuur 20 mg/g Focus, crème 20046/0256 Fusidic acid Focus 20mg/g creamNL/H/2757/001 Netherlands 112368 Frovatriptan Teva 2,5 mg 00289/1817 Frovatriptan 2.5mg tabsDE/H/0690/009 Netherlands 112771 Medikinet CR 50mg capsules met gereguleerde afgifte, hard 11243/0011 Medikinet XL 50mg capsNL/H/3951/001 Netherlands 113327 Telmisartan Hydrochlorothiazide Glenmark 40mg/12.5mg tabletten 25258/0113 Telmisartan/Hydrochlorothiazide 40/12.5mgDE/H/5733/001 Netherlands 113654 Versatis 700mg pleister 21727/0016 Versatis 700mg medicated plasterFR/H/0645/008 Netherlands 115444 Humuline NPH Kwikpen 00006/0672 Humulin I 100IU/ml KwikpenES/H/0653/001 Netherlands 116447 Tiotrus 10 microgram/dosis inhalatiepoeder in harde capsules 00289/1870 Braltus 10mcg inhalation powderES/H/0653/001 Netherlands 116447 Tiotrus 10 microgram/dosis inhalatiepoeder in harde capsules 00289/1870 Braltus 10mcg inhalation powderNL/H/3441/001 Netherlands 116941 Calcipotriol/Betamethason Sandoz 50 microgram/g + 0,5 mg/g, zalf 04416/1449 Calcipotriol/Betamethasone 50/500ug/g DK/H/0134/003 Netherlands 120935 Cosopt Multidose conserveermiddelvrij 20mg/ml + 5mg/ml oogdruppels, oplossing 16058/0025 Cosopt iMultiAT/H/0754/001 Netherlands 121191 Clexane 12.000IE (120mg)/0,8ml oplossing voor injectie in een voorgevulde spuit 04425/0185 Clexane Forte 12000IU (120mg)/0.8mlAT/H/0754/002 Netherlands 121192 Clexane 15.000IE (150mg)/1ml oplossing voor injectie in een voorgevulde spuit 04425/0185 Clexane Forte 15000IU (150mg)/1mlSE/H/0527/003 Norway 7636 Zestril tablet 10mg 17901/0062 Zestril 10mg tabsSE/H/0527/004 Norway 7637 Zestril tablet 20mg 17901/0063 Zestril 20mg tabsDE/H/2625/001 Norway 8065 Triatec 1,25mg 04425/0356 Tritace 1.25mg tabsDE/H/2625/002 Norway 8066 Triatec 2,5mg 04425/0357 Tritace 2.5mg tabsDE/H/2625/003 Norway 8067 Triatec 5,0mg 04425/0358 Tritace 5mg tabsNL/H/1539/002 Norway 8198 Lamictal 5mg dispergerbare/tyggetabletter 00003/0346 Lamictal 5mg dispersible tabsNL/H/1539/003 Norway 8199 Lamictal 25mg dispergerbare/tyggetabletter 00003/0347 Lamictal 25mg dispersible tabsNL/H/1539/005 Norway 8200 Lamictal 100mg dispergerbare/tyggetabletter 00003/0348 Lamictal 100mg dispersible tabsDE/H/0899/002 Norway 8220 Neurontin 300mg 50622/0047 Neurontin 300mg capsDE/H/0899/003 Norway 8221 Neurontin 400mg 00057/0537 Neurontin 400mg capsSE/H/1843/001 Norway 00-1709 Zidoval gel 46302/0153 Zidoval 7.5mg/g Vaginal gelDE/H/6220/001 Norway 00-1938 Malarone 250 mg/100 mg filmdrasjerte tabletter 10949/0258 Malarone tabsES/H/0102/001 Norway 00-1969 Almogran film-coated tablet 12,5 mg 16973/0005 Almogran 12.5mg tabsDE/H/0899/001 Norway 00-2995 Neurontin 100mg kapsler 00057/0535 Neurontin 100mg capsNL/H/0150/001 Norway 00-3543 Nexplanon 68 mg implantat til subkutan bruk 00025/0563 NexplanonSE/H/0225/001 Norway 00-4682 Zaditen 20162/0019 Zaditen 0.25mg/ml eye dropsSE/H/0229/001 Norway 00-5869 Symbicort Turbuhaler 160 mikrogram/4.5 mikrogram/inhalasjon, inhalasjonspulver 17901/0092 Symbicort 200/6 TurbohalerSE/H/0230/001 Norway 00-5870 Symbicort mite Turbuhaler 80 mikrogram/4.5 mikrogram/inhalasjon, inhalasjonspulver 17901/0091 Symbicort 100/6 TurbohalerSE/H/0406/003 Norway 00-6229 Diovan 80mg filmdrasjerte tabletter 00101/0600 Diovan 80mg tabsSE/H/0406/004 Norway 00-6230 Diovan 160mg filmdrasjerte tabletter 00101/0601 Diovan 160mg tabsNL/H/1457/002 Norway 00-8059 Cozaar 50mg tabletter filmdrasjerte 00025/0324 Cozaar 50mg tabsDE/H/4019/002 Norway 00-8060 Sandimmun Neoral 25mg myke kapsler 00101/0387 Neoral 25mg soft capsDE/H/4019/004 Norway 00-8061 Sandimmun Neoral 100mg myke kapsler 00101/0389 Neoral 100mg soft capsDE/H/4019/005 Norway 00-8062 Sandimmun Neoral 100mg/ml mikstur 00101/0390 Neoral 100mg/ml solution

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductNL/H/3915/002 Norway 00-8097 Durogesic 25 mikrogram/time depotplaster 00242/0192 Durogesic DTrans 25ug/hrNL/H/3915/003 Norway 00-8098 Durogesic 50 mikrogram/time depotplaster 00242/0193 Durogesic DTrans 50ug/hrNL/H/3915/004 Norway 00-8099 Durogesic 75 mikrogram/time depotplaster 00242/0194 Durogesic DTrans 75ug/hrNL/H/3915/005 Norway 00-8100 Durogesic 100 mikrogram/time depotplaster 00242/0195 Durogesic DTrans 100ug/hrDE/H/5646/001 Norway 01-0454 Caverject Dual 10 mikrogram/ 0,5 ml Pulver og væske til injeksjonsvæske, oppløsning.00057/0939 Caverject DCS 10ugDE/H/5646/002 Norway 01-0455 Caverject Dual 20 mikrogram/ 0,5 ml Pulver og væske til injeksjonsvæske, oppløsning.00057/0940 Caverject DCS 20ugNL/H/0132/003 Norway 01-0815 Remeron - S 15mg 00025/0546 Zispin 15mg SoltabNL/H/0132/003 Norway 01-0816 Remeron - S 30mg 00025/0547 Zispin 30mg SoltabSE/H/0565/002 Norway 01-10079 Diovan Comp 160 mg/12,5 mg filmdrasjerte tabletter 00101/0650 Co-Diovan 160/12.5mg tabsSE/H/0565/003 Norway 01-10080 Diovan Comp 160 mg/25 mg filmdrasjerte tabletter 00101/0651 Co-Diovan 160/25mg tabsNL/H/0299/001 Norway 01-12293 Spiriva 18 mikrogram inhalasjonspulver, hard kapsel 14598/0062 Spiriva 18mcg inhalation powderSE/H/0249/001 Norway 01-2209 Xalcom, 50 mikrogram/ml og 5 mg/ml, øyedråper, oppløsning 00057/1056 Xalacom eye dropsNL/H/0265/001 Norway 01-2232 NuvaRing 0,120mg/0,015 mg per 24 timer, vaginalinnlegg 00025/0565 NuvaRingSE/H/0139/004 Norway 01-3747 Detrusitol SR 4 mg depotkapsler, harde 50622/0017 Detrusitol XL 4mg capsDE/H/0299/001 Norway 01-4669 Xyzal 5mg filmdrasjerte tabletter 00039/0539 Xyzal 5mg tabsNL/H/1457/003 Norway 01-6335 Cozaar 100mg tabletter filmdrasjerte 00025/0416 Cozaar 100mg tabsDK/H/0279/001 Norway 01-8069 Daivobet 50 mikrogram/g + 0,5mg/g, salve 05293/0003 Dovobet ointmentSE/H/0229/002 Norway 02-1014 Symbicort forte Turbuhaler 320 mikrogram/9 mikrogram/inhalasjon, inhalasjonspulver 17901/0200 Symbicort 400/12 TurbohalerSE/H/0198/001 Norway 02-1061 Celebra 100mg harde kapsler 50622/0011 Celebrex 100mg capsSE/H/0198/002 Norway 02-1062 Celebra 200mg harde kapsler 50622/0012 Celebrex 200mg capsSE/H/0147/001 Norway 02-1079 Cerazette 75 mikrogram filmdrasjerte tabletter 00025/0562 Cerazette 75mcg tabsDE/H/6007/001 Norway 02-1221 Concerta 18mg depottabletter. 00242/0372 Concerta XL 18mg tabsDE/H/6007/002 Norway 02-1222 Concerta 36mg depottabletter. 00242/0373 Concerta XL 36mg tabsDE/H/6007/003 Norway 02-1223 Concerta 54mg depottabletter. 00242/0374 Concerta XL 54mg tabsSE/H/0304/001 Norway 02-1382 Avodart 0.5mg 19494/0006 Avodart 0.5mg soft capsNL/H/0156/001 Norway 02-1435 Seroquel 25mg filmdrasjerte tabletter 50827/0002 Seroquel 25mg tabsNL/H/0156/002 Norway 02-1436 Seroquel 100mg filmdrasjerte tabletter 50827/0003 Seroquel 100mg tabsNL/H/0156/003 Norway 02-1438 Seroquel 200mg filmdrasjerte tabletter 50827/0004 Seroquel 200mg tabsNL/H/0156/007 Norway 02-1439 Seroquel 300mg filmdrasjerte tabletter 50827/0005 Seroquel 300mg tabsDE/H/0396/001 Norway 02-1512 Ezetrol 10mg tabletter 00025/0609 Ezetrol 10mg tabsDE/H/0384/001 Norway 02-1565 Olmetec 10mg tabletter, filmdrasjerte 08265/0015 Olmetec 10mg tabsDE/H/5854/001 Norway 02-1566 Solaraze gel 3% 16973/0012 Solaraze 3% gelDE/H/0384/002 Norway 02-1567 Olmetec 20mg tabletter, filmdrasjerte 08265/0016 Olmetec 20mg tabsDE/H/0384/003 Norway 02-1568 Olmetec 40mg tabletter, filmdrasjerte 08265/0017 Olmetec 40mg tabsNL/H/0566/004 Norway 03-1911 Seroxat, film-coated tablet, 10mg 10592/0218 Seroxat 10mg tabsSE/H/0406/005 Norway 04-2470 Diovan 40mg filmdrasjerte tabletter 00101/0599 Diovan 40mg tabsNL/H/0487/001 Norway 04-2481 Vesicare 5mg 00166/0197 Vesicare 5mg tabsNL/H/0487/002 Norway 04-2482 Vesicare 10mg 00166/0198 Vesicare 10mg tabsFI/H/0313/001 Norway 04-2635 Nebido 1000mg/4ml injeksjonsvæske oppløsning 00010/0549 Nebido 1000mg/4ml injDE/H/0496/002 Norway 04-2656 Inegy 10mg/20mg tablet 00025/0610 Inegy 10mg/20mg tabsDE/H/0496/003 Norway 04-2657 Inegy 10mg/40mg tablet 00025/0611 Inegy 10mg/40mg tabsNL/H/3915/001 Norway 04-2767 Durogesic 12 mikrogram/time depotplaster 00242/0409 Durogesic DTrans 12ug/hrSE/H/1861/001 Norway 04-2871 Alvesco 80mikrog/dose 17901/0297 Alvesco 80 inhalerSE/H/1861/002 Norway 04-2872 Alvesco 160mikrog/dose 17901/0298 Alvesco 160 inhalerDK/H/0718/001 Norway 04-3090 Norspan 5 mikrog/time depotplaster 16950/0136 BuTrans 5mcg/h patchDK/H/0718/002 Norway 04-3091 Norspan 10 mikrog/time depotplaster 16950/0137 BuTrans 10mcg/h patchDK/H/0718/003 Norway 04-3092 Norspan 20 mikrog/time depotplaster 16950/0138 BuTrans 20mcg/h patchFI/H/0981/001 Norway 05-3429 Tobrasone 3 mg/ml / 1 mg/ml, øyedråper, suspensjon 00101/1007 Tobradex eye drops

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductDE/H/0523/001 Norway 05-3517 Olmetec Comp 20mg/12,5mg tabletter, filmdrasjerte 08265/0022 Olmetec Plus 20mg/12.5mg tabsDE/H/0523/002 Norway 05-3518 Olmetec Comp 20mg/25mg tabletter, filmdrasjerte 08265/0023 Olmetec Plus 20mg/25mg tabsDK/H/3023/001 Norway 05-3535 Combigan eye drops, solution 2 mg/ml/5 mg/ml 41443/0006 Combigan eye dropsNL/H/1458/002 Norway 05-3601 Cozaar Comp 100mg/12.5mg 00025/0473 Cozaar Comp 100mg/12.5mgSE/H/0406/006 Norway 05-3646 Diovan 320mg filmdrasjerte tabletter 00101/0726 Diovan 320mg tabsDK/H/2888/001 Norway 05-3711 Equasym Depot 10mg 27303/0004 Equasym XL 10mg capsDK/H/2888/002 Norway 05-3712 Equasym Depot 20mg 27303/0005 Equasym XL 20mg capsDK/H/2888/003 Norway 05-3713 Equasym Depot 30mg 27303/0006 Equasym XL 30mg capsSE/H/0571/001 Norway 05-3864 Tostran 2% gel 16508/0025 Tostran 2% gelNL/H/0732/001 Norway 06-3932 Mezavant 1200mg entero-og depottabletter 08081/0040 Mezavant XL 1200mg tabsSE/H/0481/002 Norway 06-4022 Fosrenol 500 mg tyggetabletter 08081/0042 Fosrenol 500mg tabsSE/H/0481/003 Norway 06-4023 Fosrenol 750 mg tyggetabletter 08081/0043 Fosrenol 750mg tabsSE/H/0481/004 Norway 06-4024 Fosrenol 1000mg tyggetabletter 08081/0044 Fosrenol 1000mg tabsDE/H/0690/001 Norway 06-4110 Medikinet 5mg tabletter 11243/0002 Medikinet 5mg tabsDE/H/0690/002 Norway 06-4117 Medikinet 10mg tabletter 11243/0003 Medikinet 10mg tabsDE/H/0690/003 Norway 06-4118 Medikinet 20mg tabletter 11243/0004 Medikinet 20mg tabsDE/H/0690/004 Norway 06-4119 Medikinet 10 mg kapsler med modifisert frisetting, harde 11243/0005 Medikinet XL 10mg capsDE/H/0690/005 Norway 06-4120 Medikinet 20 mg kapsler med modifisert frisetting, harde 11243/0006 Medikinet XL 20mg capsDE/H/0690/006 Norway 06-4121 Medikinet 30 mg kapsler med modifisert frisetting, harde 11243/0007 Medikinet XL 30mg capsDE/H/0690/007 Norway 06-4122 Medikinet 40 mg kapsler med modifisert frisetting, harde 11243/0008 Medikinet XL 40mg capsNL/H/0718/001 Norway 06-4361 Spiriva 2,5 mikrogram inhalasjonsvaeske, opplosning 14598/0084 Spiriva RespimatDE/H/1147/001 Norway 07-5004 Fentanyl Sandoz transdermal patch 12 micrograms/hr 04416/0844 Mezolar Matrix transd patch 12ug/hrDE/H/1147/002 Norway 07-5005 Fentanyl Sandoz transdermal patch 25 micrograms/hr 04416/0845 Mezolar Matrix transd patch 25ug/hrDE/H/1147/003 Norway 07-5006 Fentanyl Sandoz transdermal patch 37.5 micrograms/hr 04416/0846 Mezolar Matrix transd patch 37.5ug/hrDE/H/1147/004 Norway 07-5007 Fentanyl Sandoz transdermal patch 50 micrograms/hr 04416/0847 Mezolar Matrix transd patch 50ug/hrDE/H/1147/005 Norway 07-5008 Fentanyl Sandoz transdermal patch 75 micrograms/hr 04416/0848 Mezolar Matrix transd patch 75ug/hrDE/H/1147/006 Norway 07-5009 Fentanyl Sandoz transdermal patch 100 micrograms/hr 04416/0849 Mezolar Matrix transd patch 100ug/hrDK/H/0279/002 Norway 07-5054 Daivobet 50 mikrogram/g +0,5 mg/g Gel 05293/0005 Dovobet gelSE/H/0643/001 Norway 07-5206 Metex solution for injection 50mg/ml 11587/0046 Metoject 50mg/ml soln for injNL/H/0156/008 Norway 07-5214 Seroquel Depot 50mg depottabletter 50827/0006 Seroquel XL 50mg tabsNL/H/0156/009 Norway 07-5215 Seroquel Depot 200mg depottabletter 50827/0008 Seroquel XL 200mg tabsNL/H/0156/010 Norway 07-5216 Seroquel Depot 300mg depottabletter 50827/0009 Seroquel XL 300mg tabsNL/H/0156/011 Norway 07-5217 Seroquel Depot 400mg depottabletter 50827/0010 Seroquel XL 400mg tabsDE/H/0873/001 Norway 07-5330 Inuxair pressurised inhalation, solution 100 mikrog/6 mikrog 08829/0157 Formodual 100/6 micrograms inhalerDK/H/1405/001 Norway 07-5440 Xamiol 50 mikrogram/g + 0.5 mg/g gel 05293/0006 Xamiol gelDE/H/6007/004 Norway 08-5646 Concerta 27mg depottabletter. 00242/0400 Concerta XL 27mg tabsDK/H/1490/001 Norway 08-5688 Lerkanidipin Actavis 10 mg 00142/1154 Lercanidipine hydrochloride 10mg tabsDK/H/1490/002 Norway 08-5689 Lerkanidipin Actavis 20 mg 00142/1155 Lercanidipine hydrochloride 20mg tabsFR/H/0228/001 Norway 08-5745 Duraphat 5mg/g 00049/0050 Duraphat 5000ppm fluoride toothpasteNL/H/0156/012 Norway 08-5880 Seroquel Depot 150mg depottabletter 50827/0007 Seroquel XL 150mg tabsDE/H/1612/003 Norway 08-5980 Targiniq 40mg/20mg 16950/0161 Targinact 40mg/20mg tabsDE/H/1612/004 Norway 08-5981 Targiniq 5mg/2.5mg 16950/0162 Targinact 5mg/2.5mg tabsNL/H/0343/004 Norway 08-6072 Crestor 5 mg filmdrasjerte tabletter 17901/0243 Crestor 5mg tabsNL/H/0343/001 Norway 08-6073 Crestor 10 mg filmdrasjerte tabletter 17901/0201 Crestor 10mg tabsNL/H/0343/002 Norway 08-6074 Crestor 20 mg filmdrasjerte tabletter 17901/0202 Crestor 20mg tabsDE/H/1612/001 Norway 08-6097 Targiniq 10mg/5mg 16950/0157 Targinact 10mg/5mg tabsDE/H/1612/002 Norway 08-6098 Targiniq 20mg/10mg 16950/0158 Targinact 20mg/10mg tabsDE/H/2251/001 Norway 08-6438 Duodart 0,5mg/0,4mg harde kapsler 19494/0046 Combodart 0.5mg/0.4mg caps

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductDK/H/1377/001 Norway 09-6715 Toctino 10mg kapsler myke 19494//0223 Toctino 10mg soft capsDK/H/1377/002 Norway 09-6716 Toctino 30mg kapsler myke 19494//0253 Toctino 30mg soft capsDE/H/2020/004 Norway 09-6806 Palexia depot 50mg 21727/0041 Palexia SR 50mg tabsDE/H/2020/005 Norway 09-6807 Palexia depot 100mg 21727/0042 Palexia SR 100mg tabsDE/H/2020/006 Norway 09-6808 Palexia depot 150mg 21727/0043 Palexia SR 150mg tabsDE/H/2020/007 Norway 09-6809 Palexia depot 200mg 21727/0044 Palexia SR 200mg tabsDE/H/2020/008 Norway 09-6810 Palexia depot 250mg 21727/0045 Palexia SR 250mg tabsDE/H/5683/001 Norway 09-7087 Budenofalk gastro-resistant granules 9mg 08637/0020 Budenofalk 9mg granulesNL/H/1848/001 Norway 09-7130 Vimovo 500mg /20mg Tabletter 17901/0263 Vimovo 500mg/20mg tabsSE/H/0908/001 Norway 09-7184 Jext 150 mikrogram injeksjonsvæske, oppløsning i ferdigfylt penn 10085/0052 Jext 150mcg PenSE/H/0908/002 Norway 09-7185 Jext 300 mikrogram injeksjonsvæske, oppløsning i ferdigfylt penn 10085/0053 Jext 300mcg PenDK/H/2871/001 Norway 09-7276 Picoprep 03194/0014 PicolaxSE/H/1921/001 Norway 10-7474 Flutiform, inhalationaerosol, suspension, 50mikrog/5mikrog 16950/0167 Flutiform 50mcg/5mcg inhalerSE/H/1921/002 Norway 10-7475 Flutiform, inhalationaerosol, suspension, 125mikrog/5mikrog 16950/0168 Flutiform 125mcg/5mcg inhalerSE/H/1921/003 Norway 10-7476 Flutiform, inhalationaerosol, suspension, 250mikrog/10mikrog 16950/0169 Flutiform 250mcg/10mcg inhalerDE/H/5733/001 Norway 10-7564 Versatis 700mg medisinert plaster 21727/0016 Versatis 700mg medicated plasterDE/H/0690/008 Norway 10-7785 Medikinet 5 mg kapsler med modifisert frisetting, harde 11243/0010 Medikinet XL 5mg capsNL/H/0144/002 Norway 10-8010 Maxalt 10mg 00025/0370 Maxalt 10mg tabsNL/H/0144/004 Norway 10-8012 Maxalt Rapitab 10mg 00025/0372 Maxalt Melt 10mgDK/H/2028/001 Norway 10-8123 Methylphenidate Sandoz 18mg depottabletter 04416/1346 Matoride XL 18mg tabsDK/H/2028/002 Norway 10-8124 Methylphenidate Sandoz 36mg depottabletter 04416/1348 Matoride XL 36mg tabsDK/H/2028/003 Norway 10-8125 Methylphenidate Sandoz 54mg depottabletter 04416/1349 Matoride XL 54mg tabsSE/H/1074/001 Norway 11-8201 Latanoprost/Timolol Pfizer øyedråper, oppløsning 50 mikrog/ml/5 mg/ml 00057/1322 Latanoprost/Timolol Pfizer 50+5 ug/mlFR/H/0499/001 Norway 11-8494 Monoprost 50 mikrogram/ml, øyedråper, oppløsning i endosebeholder 20162/0015 Monopost 50mcg/ml eye drops SDUNL/H/4511/001 Norway 11-8645 Xifaxan film-coated tablet 550mg 20011/0020 Targaxan 550mg tabsDE/H/3355/001 Norway 11-8686 Dymista Nesespray, suspensjon 137 mikrogram / 50 mikrogram per spray 15142/0258 Dymista Nasal SprayNL/H/4539/001 Norway 11-8809 Sativex Munnspray 18024/0009 Sativex Oromucosal SpraySE/H/0643/002 Norway 12-9071 Metex 7,5mg injeksjonsvaeske,opplosning i ferdigfylt penn 11587/0076 Metoject Pen 7.5mgSE/H/0643/003 Norway 12-9072 Metex 10mg injeksjonsvaeske,opplosning i ferdigfylt penn 11587/0077 Metoject Pen 10mgSE/H/0643/004 Norway 12-9073 Metex 12.5mg injeksjonsvaeske,opplosning i ferdigfylt penn 11587/0078 Metoject Pen 12.5mgSE/H/0643/005 Norway 12-9074 Metex 15mg injeksjonsvaeske,opplosning i ferdigfylt penn 11587/0079 Metoject Pen 15mgSE/H/0643/006 Norway 12-9075 Metex 17.5mg injeksjonsvaeske,opplosning i ferdigfylt penn 11587/0080 Metoject Pen 17.5mgSE/H/0643/007 Norway 12-9076 Metex 20mg injeksjonsvaeske,opplosning i ferdigfylt penn 11587/0081 Metoject Pen 20mgSE/H/0643/008 Norway 12-9077 Metex 22.5mg injeksjonsvaeske,opplosning i ferdigfylt penn 11587/0082 Metoject Pen 22.5mgSE/H/0643/009 Norway 12-9078 Metex 25mg injeksjonsvaeske,opplosning i ferdigfylt penn 11587/0083 Metoject Pen 25mgSE/H/0643/011 Norway 12-9080 Metex 30mg injeksjonsvaeske,opplosning i ferdigfylt penn 11587/0085 Metoject Pen 30mgNL/H/2498/001 Norway 12-9096 Striverdi solution for inhalation 2,5 microg 14598/0093 Striverdi Respimat DE/H/0690/009 Norway 12-9267 Medikinet 50mg kapsler med modifisert frisetting, harde 11243/0011 Medikinet XL 50mg capsDE/H/0690/010 Norway 12-9268 Medikinet 60 mg kapsler med modifisert frisetting, harde 11243/0012 Medikinet XL 60mg capsSE/H/1428/001 Norway 14-10067 Soolantra cream 10mg/g 10949/0063 Soolantra 10mg/g creamDK/H/0134/003 Norway 17-11651 Cosopt sine 20mg/ml + 5mg/ml øyedråper, oppløsning 16058/0025 Cosopt iMultiAT/H/0754/002 Norway 17-11775 Klexane 15 000IU (150mg)/1ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte 04425/0185 Clexane Forte 15000IU (150mg)/1mlIE/H/0165/002 Norway 94-1701 Prograf capsule, hard, 1mg 00166/0203 Prograf 1mg hard capsSE/H/1041/002 Norway 94-1771 Valtrex 500mg film coated tablets 00003/0352 Valtrex 500mg tabsDE/H/4019/003 Norway 95-2610 Sandimmun Neoral 50mg myke kapsler 00101/0388 Neoral 50mg soft capsNL/H/1458/001 Norway 96-1305 Cozaar Comp 50mg/12.5mg 00025/0338 Cozaar Comp 50mg/12.5mgNL/H/1539/004 Norway 96-1876 Lamictal 50mg dispergerbare/tyggetabletter 00003/0368 Lamictal 50mg dispersible tabsDE/H/0109/003 Norway 96-3034 Lipitor 40mg 50622/0041 Lipitor 40mg tabs

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductSE/H/1821/001 Norway 96-3298 Nasonex 50 mikrogram/dose nesespray,suspensjon 00025/0587 Nasonex 50ug/actuation nasal sprayNL/H/1457/001 Norway 97-2003 Cozaar 12.5mg tabletter filmdrasjerte 00025/0515 Cozaar 12.5mg tabsSE/H/0565/001 Norway 97-2716 Diovan Comp 80 mg/12,5 mg filmdrasjerte tabletter 00101/0480 Co-Diovan 80/12.5mg tabsSE/H/1041/001 Norway 97-2744 Valtrex 250mg film coated tablets 00003/0371 Valtrex 250mg tabsIE/H/0165/001 Norway 97-3113 Prograf capsule, hard, 0.5mg 00166/0206 Prograf 0.5mg hard capsSE/H/0110/007 Norway 98-3715 Topimax 15mg kapsler 00242/0348 Topamax Sprinkle 15mg capsSE/H/0110/008 Norway 98-3716 Topimax 25mg kapsler 00242/0349 Topamax Sprinkle 25mg capsNL/H/1458/003 Norway 98-5073 Cozaar Comp Forte 100mg/25mg 00025/0374 Cozaar Comp 100mg/25mgAT/H/0754/001 Norway 99-3240 Klexane 12 000IU (120mg)/0,8ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte 04425/0185 Clexane Forte 12000IU (120mg)/0.8mlFR/H/0416/002 Poland 0900 Ciprobay 500 00010/0147 Ciproxin 500mg tabsDE/H/4019/002 Poland 3366 Sandimmun Neoral 25mg kapsułki miękkie 00101/0387 Neoral 25mg soft capsDE/H/4019/003 Poland 3367 Sandimmun Neoral 50mg kapsułki miękkie 00101/0388 Neoral 50mg soft capsDE/H/4019/004 Poland 3368 Sandimmun Neoral 100mg kapsułki miękkie 00101/0389 Neoral 100mg soft capsDE/H/4019/005 Poland 3369 Sandimmun Neoral 10mg roztwór doustny 00101/0390 Neoral 100mg/ml solutionDE/H/4019/001 Poland 4061 Sandimmun Neoral 10mg kapsułki miękkie 00101/0483 Neoral 10mg soft capsPT/H/2363/001 Poland 4193 Augmentin (400mg+57mg)/5ml, proszek do sporządzania zawiesiny doustnej 10592/0070 Augmentin Duo 400/57NL/H/1458/001 Poland 4336 Hyzaar 50mg/12.5mg tabletki powlekane 00025/0338 Cozaar Comp 50mg/12.5mgIE/H/0165/002 Poland 4472 Prograf 1mg kapsulki twarde 00166/0203 Prograf 1mg hard capsIE/H/0165/003 Poland 4473 Prograf 5mg kapsulki twarde 00166/0204 Prograf 5mg hard capsNL/H/1732/003 Poland 7532 Zoloft 100mg Tabletki powlekane 00057/0309 Lustral 100mg tabsAT/H/0904/001 Poland 7567 Arimidex 1mg Tabletki powlekane 17901/0002 Arimidex 1mg tabsSE/H/0110/001 Poland 7588 Topamax 25mg tabletki powlekane 00242/0301 Topamax 25mg tabsSE/H/0110/002 Poland 7589 Topamax 50mg tabletki powlekane 00242/0302 Topamax 50mg tabsSE/H/0110/003 Poland 7590 Topamax 100mg tabletki powlekane 00242/0303 Topamax 100mg tabsSE/H/0110/004 Poland 7591 Topamax 200mg tabletki powlekane 00242/0304 Topamax 200mg tabsSE/H/1821/001 Poland 7619 Nasonex, 50 mikrogramów/dawkę, aerozol do nosa, zawiesina 00025/0587 Nasonex 50ug/actuation nasal sprayNL/H/3915/002 Poland 7654 Durogesic 25 ug/h, system transdermalny, plaster 00242/0192 Durogesic DTrans 25ug/hrNL/H/3915/003 Poland 7655 Durogesic 50 ug/h, system transdermalny, plaster 00242/0193 Durogesic DTrans 50ug/hrNL/H/3915/004 Poland 7656 Durogesic 75 ug/h, system transdermalny, plaster 00242/0194 Durogesic DTrans 75ug/hrNL/H/3915/005 Poland 7657 Durogesic 100 ug/h, system transdermalny, plaster 00242/0195 Durogesic DTrans 100ug/hrDE/H/0109/002 Poland 7847 Sortis 20mg tabletki powlekane 50622/0039 Lipitor 20mg tabsDE/H/0109/003 Poland 7848 Sortis 40 tabletki powlekane 50622/0041 Lipitor 40mg tabsSE/H/0110/007 Poland 8615 Topamax 15 mg kapsulki 00242/0348 Topamax Sprinkle 15mg capsSE/H/0110/008 Poland 8616 Topamax 25 mg kapsulki 00242/0349 Topamax Sprinkle 25mg capsFI/H/0104/003 Poland 8780 Singulair 4 00025/0412 Singulair Paediatric 4mg tabsAT/H/0754/001 Poland 8914 Clexane Forte 120mg/0.8ml 04425/0185 Clexane Forte 12000IU (120mg)/0.8mlAT/H/0754/002 Poland 8915 Clexane Forte 150mg/1ml 04425/0185 Clexane Forte 15000IU (150mg)/1mlSE/H/0406/003 Poland 9291 Diovan 80mg tabletki powlekane 00101/0600 Diovan 80mg tabsSE/H/0406/004 Poland 9292 Diovan 160mg tabletki powlekane 00101/0601 Diovan 160mg tabsNL/H/1458/003 Poland 9705 Hyzaar Forte 100mg/25mg tabletki powlekanych 00025/0374 Cozaar Comp 100mg/25mgNL/H/1457/001 Poland 9978 Cozaar 12.5mg tabletki powlekane 00025/0515 Cozaar 12.5mg tabsDE/H/0109/004 Poland 10188 SORTIS 80, 80 mg, tabletki powlekane 50622/0043 Lipitor 80mg tabsDE/H/2184/015 Poland 10580 Rispolept Consta 50mg 00242/0377 Risperdal Consta 50mgDE/H/2184/014 Poland 10581 Rispolept Consta 37.5mg 00242/0376 Risperdal Consta 37.5mgDE/H/2184/013 Poland 10582 Rispolept Consta 25mg 00242/0375 Risperdal Consta 25mgSE/H/0565/003 Poland 10629 Co-Diovan 160 mg + 25 mg tabletki powlekane 00101/0651 Co-Diovan 160/25mg tabsNL/H/1457/003 Poland 10734 Cozaar 100mg tabletki powlekane 00025/0416 Cozaar 100mg tabsSE/H/0304/001 Poland 11165 Avodart 0.5mg 19494/0006 Avodart 0.5mg soft caps

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductSE/H/1861/001 Poland 11230 Alvesco 80mikrog/dose 17901/0297 Alvesco 80 inhalerSE/H/1861/002 Poland 11231 Alvesco 160mikrog/dose 17901/0298 Alvesco 160 inhalerNL/H/0487/001 Poland 11371 Vesicare 5mg 00166/0197 Vesicare 5mg tabsNL/H/0487/002 Poland 11372 Vesicare 10mg 00166/0198 Vesicare 10mg tabsDE/H/0396/001 Poland 11476 Ezetrol 10mg tabletki 00025/0609 Ezetrol 10mg tabsIE/H/0165/001 Poland 11487 Prograf 0.5mg kapsulki twarde 00166/0206 Prograf 0.5mg hard capsFI/H/0313/001 Poland 11740 Nebido 1000mg/4ml roztwór do wstrzykiwań 00010/0549 Nebido 1000mg/4ml injFR/H/0265/003 Poland 11772 Prestarium 10mg tabletki powlekane 05815/0037 Coversyl Arginine 10mg tabsFR/H/0265/002 Poland 11797 Prestarium 5mg tabletki powlekane 05815/0036 Coversyl Arginine 5mg tabsDE/H/0299/001 Poland 11895 Xyzal, 5mg, tabletki powlekane 00039/0539 Xyzal 5mg tabsFR/H/0272/003 Poland 12063 Noax Uno 300mg tabletki o przedłużonym uwalnianiu 43808/0003 Tradorec XL 300mg tabsFR/H/0272/002 Poland 12064 Noax Uno 200mg tabletki o przedłużonym uwalnianiu 43808/0002 Tradorec XL 200mg tabsFR/H/0272/001 Poland 12067 Noax Uno 100mg tabletki o przedłużonym uwalnianiu 43808/0001 Tradorec XL 100mg tabs

DK/H/3023/001 Poland 12076 Combigan 2mg/ml + 5mg/ml, krople do oczu, roztwor 41443/0006 Combigan eye dropsNL/H/0653/001 Poland 12090 Dexafree 1mg/ml krople do oczu, roztwor 20162/0013 Dexafree 1mg/ml eye dropsDE/H/6220/001 Poland 12142 Malarone 250mg+100mg tabletki powlekane 10949/0258 Malarone tabsFR/H/0228/001 Poland 12286 Duraphat 5000 Pasta do zebow 00049/0050 Duraphat 5000ppm fluoride toothpasteNL/H/0506/001 Poland 12290 Inspra tabletki 25mg powlekane 50622/0028 Inspra 25mg tabsNL/H/0506/002 Poland 12291 Inspra tabletki 50mg powlekane 50622/0029 Inspra 50mg tabsDE/H/0528/001 Poland 12407 Atimos 12 mikrogramow/dawke odmierzona aerozol inhalacyjny roztwor 08829/0154 Atimos ModuliteFR/H/0258/001 Poland 12423 Adartrel 0.25mg tabletki powlekane 19494/0033 Adartrel 0.25mg tabsFR/H/0258/002 Poland 12424 Adartrel 0.5mg tabletki powlekane 19494/0034 Adartrel 0.5mg tabsFR/H/0258/004 Poland 12426 Adartrel 2mg tabletki powlekane 19494/0036 Adartrel 2mg tabsSE/H/1876/001 Poland 12486 Serevent 25mikrogramow/dawke inhalacyjna 10949/0369 Serevent 25 EvohalerSE/H/0568/005 Poland 12762 Matrifen 100 mcg 16189/0018 Matrifen 100 micrograms/hour PatchSE/H/0568/004 Poland 12763 Matrifen 75mcg 16189/0017 Matrifen 75 micrograms/hour PatchSE/H/0568/003 Poland 12764 Matrifen 50mcg 16189/0016 Matrifen 50 micrograms/hour PatchSE/H/0568/002 Poland 12765 Matrifen 25mcg 16189/0015 Matrifen 25 micrograms/hour PatchSE/H/0568/001 Poland 12766 Matrifen 12mcg 16189/0014 Matrifen 12 micrograms/hour PatchDE/H/0690/001 Poland 12841 Medikinet 5mg tabletki 11243/0002 Medikinet 5mg tabsDE/H/0690/002 Poland 12842 Medikinet 10mg tabletki 11243/0003 Medikinet 10mg tabsDE/H/0690/003 Poland 12843 Medikinet 20mg tabletki 11243/0004 Medikinet 20mg tabsDE/H/0690/004 Poland 12844 Medikinet CR 10 mg 11243/0005 Medikinet XL 10mg capsDE/H/0690/005 Poland 12845 Medikinet CR 20 mg 11243/0006 Medikinet XL 20mg capsDE/H/0690/006 Poland 12846 Medikinet CR 30 mg 11243/0007 Medikinet XL 30mg capsDE/H/0690/007 Poland 12847 Medikinet CR 40 mg 11243/0008 Medikinet XL 40mg capsSE/H/0406/006 Poland 12928 Diovan 320mg tabletki powlekane 00101/0726 Diovan 320mg tabsNL/H/3915/001 Poland 12949 Durogesic 12 ug/h, system transdermalny, plaster 00242/0409 Durogesic DTrans 12ug/hrDE/H/0871/001 Poland 12954 Fostex, (100 mikrogramów + 6 mikrogramów)/dawkę, aerozol inhalacyjny, roztwór 08829/0156 Fostair 100/6 inhalerFR/H/0130/004 Poland 12990 Tertensif Kombi 5mg/1.25mg tabletki powlekane 05815/0052 Coversyl Arginine Plus 5/1.25mg tabsSE/H/0406/005 Poland 14041 Diovan 40mg tabletki powlekane 00101/0599 Diovan 40mg tabsNL/H/0265/001 Poland 14121 NuvaRing (0,120mg+0,015 mg)/24 h 00025/0565 NuvaRingSE/H/0581/001 Poland 14350 Axyven 37.5 mg tabletka o przedluzonym uwalnianiu 01883/0338 Venlalic XL 37.5mg tabsSE/H/0581/002 Poland 14351 Axyven 75mg tabletka o przedluzonym uwalnianiu 01883/0339 Venlalic XL 75mg tabsSE/H/0581/003 Poland 14352 Axyven 150 mg tabletka o przedluzonym uwalnianiu 01883/0340 Venlalic XL 150mg tabsDE/H/6007/001 Poland 14751 Concerta 18mg tabletki o przedluzonym uwalnianiu 00242/0372 Concerta XL 18mg tabsDE/H/6007/002 Poland 14752 Concerta 36mg tabletki o przedluzonym uwalnianiu 00242/0373 Concerta XL 36mg tabsDE/H/0991/002 Poland 15023 Taflotan 15 mikrogramow/ml, krople do oczu, roztwor 16058/0017 Saflutan 15ug/ml eye drops

Version: 11/11/2020 Page: 51 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductFI/H/0104/004 Poland 15421 Singulair mini 4 mg granulat 00025/0440 Singulair Paediatric 4mg granulesFR/H/0181/006 Poland 15720 Glucophage 1000mg proszek do sporzadzania roztworu doustnego 11648/0090 Glucophage 1000mg powder for solutionCZ/H/0933/002 Poland 15910 Trexan 10mg tabletki 27925/0019 Methotrexate 10mg tabsDE/H/1612/003 Poland 16108 Targin 40mg+20mg tabletki o przedluzonym uwalnianiu 16950/0161 Targinact 40mg/20mg tabsNL/H/0718/001 Poland 16125 Spiriva Respimat, 2,5 mikrograma/dawkę odmierzoną, roztwór do inhalacji 14598/0084 Spiriva RespimatSE/H/0643/001 Poland 16976 Metex 50mg/ml Roztwor do wstrzykiwan w ampulko-strzykawce 11587/0046 Metoject 50mg/ml soln for injDE/H/2251/001 Poland 17029 Duodart 0.5mg + 0.4mg kapsulki twarde 19494/0046 Combodart 0.5mg/0.4mg capsDE/H/2251/001 Poland 17029 Duodart, 0,5mg+0,4 mg, kapsułki twarde 19494/0046 Combodart 0.5mg/0.4mg capsNL/H/2280/002 Poland 17296 Femoston mini 0,5mg + 2,5mg, tabletki powlekane 46302/0037 Femoston-Conti 0.5mg/2.5mg tabsDE/H/5733/001 Poland 17841 Versatis, 700mg, plaster leczniczy 21727/0016 Versatis 700mg medicated plasterDE/H/2020/004 Poland 18192 Palexia retard 50mg tabletki o przedłużonym uwalnianiu 21727/0041 Palexia SR 50mg tabsDE/H/2020/005 Poland 18193 Palexia retard 100mg tabletki o przedłużonym uwalnianiu 21727/0042 Palexia SR 100mg tabsDE/H/2020/006 Poland 18194 Palexia retard 150mg tabletki o przedłużonym uwalnianiu 21727/0043 Palexia SR 150mg tabsDE/H/2020/007 Poland 18195 Palexia retard 200mg tabletki o przedłużonym uwalnianiu 21727/0044 Palexia SR 200mg tabsDE/H/2020/008 Poland 18196 Palexia retard 250mg tabletki o przedłużonym uwalnianiu 21727/0045 Palexia SR 250mg tabsSE/H/0230/001 Poland 18333 Symbicort Turbuhaler 80 mcg + 4.5 mcg 17901/0091 Symbicort 100/6 TurbohalerSE/H/0229/001 Poland 18334 Symbicort Turbuhaler 160 mcg + 4.5 mcg 17901/0092 Symbicort 200/6 TurbohalerDE/H/0690/008 Poland 18355 Medikinet CR 5mg 11243/0010 Medikinet XL 5mg capsNL/H/0732/001 Poland 18801 Mezavant 1200mg tabletki dojelitowe o przedłużonym uwalnianiu 08081/0040 Mezavant XL 1200mg tabsSE/H/0229/002 Poland 18981 Symbicort Turbuhaler 320 mcg + 9 mcg 17901/0200 Symbicort 400/12 TurbohalerDK/H/0279/002 Poland 19744 Daivobet 50 micrograme/0,5mg/g gel 05293/0005 Dovobet gelNL/H/3926/001 Poland 19880 Hylosept 20mg/g krem 20046/0256 Fusidic acid Focus 20mg/g creamDK/H/2028/001 Poland 19975 Difumenil 18mg tabletki o przedłużonym uwalnianiu 04416/1346 Matoride XL 18mg tabsDK/H/2028/002 Poland 19976 Difumenil 36mg tabletki o przedłużonym uwalnianiu 04416/1348 Matoride XL 36mg tabsDK/H/2028/003 Poland 19977 Difumenil 54mg tabletki o przedłużonym uwalnianiu 04416/1349 Matoride XL 54mg tabsDE/H/2020/009 Poland 20417 Palexia retard 25mg tabletki o przedłużonym uwalnianiu 21727/0051 Palexia SR 25mg tabsFR/H/0499/001 Poland 20654 Monoprost 50 mikrogram/ml 20162/0015 Monopost 50mcg/ml eye drops SDUNL/H/2564/001 Poland 20799 Propranolol Accord 10mg, tabletki powlekane 20075/0360 Propranolol 10mg tabsNL/H/2564/002 Poland 20800 Propranolol Accord 40mg, tabletki powlekane 20075/0361 Propranolol 40mg tabsDE/H/0871/002 Poland 20878 Fostex Nexthaler (100 mikrogramów + 6 mikrogramów)/dawkę inhalacyjną, proszek do 08829/0173 Fostair Nexthaler 100/6NL/H/0150/001 Poland 21319 Implanon NXT 00025/0563 NexplanonDE/H/3355/001 Poland 21388 Dymista (137 mikrogramów + 50 mikrogramów)/dawkę donosową, aerozol do nosa, zaw15142/0258 Dymista Nasal SprayNL/H/3137/001 Poland 22882 Srivasso 18ug proszek do inhalacji w kapsulce twardej 14598/0100 Srivasso 18mcg capsES/H/0653/001 Poland 23520 Braltus 10 mikrogramow/dawke dostarczona proszek do inhalacji w kapsulce twardej 00289/1870 Braltus 10mcg inhalation powderDK/H/0134/003 Poland 25030 Cosopt PF Multi 20mg/ml + 5mg/ml, krople do oczu, roztwór 16058/0025 Cosopt iMultiIE/H/0715/001 Poland R/0641 Augmentin 250mg+125mg tabletki powlekane 00038/0270 Augmentin 375mg tabsIE/H/0209/001 Poland R/1846 Zyrtec 10mg tabletki powlekane 00039/0542 Zirtek Alergy 10mg tabsNL/H/2081/002 Poland R/1937 Losec 20mg, kapsułki dojelitowe, twarde 17901/0133 Losec 20mg capsNL/H/1540/002 Poland R/3462 Lamitrin 50mg Tabletki 00003/0273 Lamictal 50mg tabsNL/H/1540/003 Poland R/3463 Lamitrin 100mg Tabletki 00003/0274 Lamictal 100mg tabsNL/H/1540/001 Poland R/3548 Lamitrin 25mg Tabletki 00003/0272 Lamictal 25mg tabsDE/H/2184/005 Poland R/6706 Rispolept 3mg tabletki powlekane 00242/0188 Risperdal 3mg tabsDE/H/2184/006 Poland R/6707 Rispolept 4mg tabletki powlekane 00242/0189 Risperdal 4mg tabsNL/H/1457/002 Poland R/6744 Cozaar 50mg tabletki powlekane 00025/0324 Cozaar 50mg tabsNL/H/1540/002 Portugal 2252989 Lamictal 50mg comprimido 00003/0273 Lamictal 50mg tabsNL/H/1540/003 Portugal 2253185 Lamictal 100mg comprimido 00003/0274 Lamictal 100mg tabsFR/H/0070/001 Portugal 2303584 Trusopt 20 mg/ml colírio, solução 16058/0014 Trusopt Eye DropsDK/H/2848/001 Portugal 2310282 Iopidine 5mg/ml colírio, solução 00101/0996 Iopidine 5mg/ml eye drops

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductNL/H/1457/002 Portugal 2317584 Cozaar 50mg comprimidos revestidos por película 00025/0324 Cozaar 50mg tabsNL/H/1457/002 Portugal 2317782 Cozaar 50mg comprimidos revestidos por película 00025/0324 Cozaar 50mg tabsNL/H/0102/001 Portugal 2401180 Nebilet 5mg Tablets 16239/0019 Hypoloc 5mg tabsNL/H/0103/001 Portugal 2401388 Hypoloc 5mg Tablets 16239/0013 Nebilet 5mg tabsNL/H/3915/002 Portugal 2505287 Durogesic 25 microgramas/hora sistema transdérmico 00242/0192 Durogesic DTrans 25ug/hrNL/H/3915/003 Portugal 2505386 Durogesic 50 microgramas/hora sistema transdérmico 00242/0193 Durogesic DTrans 50ug/hrNL/H/3915/004 Portugal 2505485 Durogesic 75 microgramas/hora sistema transdérmico 00242/0194 Durogesic DTrans 75ug/hrNL/H/3915/005 Portugal 2505584 Durogesic 100 microgramas/hora sistema transdérmico 00242/0195 Durogesic DTrans 100ug/hrNL/H/4790/001 Portugal 2511681 Zanicor 10mg comprimido revestido por pelicula 04595/0005 Zanidip 10mg tabsNL/H/1539/002 Portugal 2521680 Lamictal 5mg comprimidos dispersiveis ou para mastigar 00003/0346 Lamictal 5mg dispersible tabsNL/H/1539/003 Portugal 2521888 Lamictal 25mg comprimidos dispersiveis ou para mastigar 00003/0347 Lamictal 25mg dispersible tabsNL/H/1458/001 Portugal 2530780 Cozaar Plus 50mg+12.5mg comprimidos revestidos por pelicula 00025/0338 Cozaar Comp 50mg/12.5mgNL/H/1458/001 Portugal 2530889 Cozaar Plus 50mg+12.5mg comprimidos revestidos por pelicula 00025/0338 Cozaar Comp 50mg/12.5mgSE/H/0121/002 Portugal 2540383 Oxis Turbohaler 9 microgramas por dose po para inalacoa 17901/0153 Oxis Turbohaler 12DE/H/6157/001 Portugal 2547388 Xalatan 50 μg/ml 00057/1057 Xalatan eye dropsIE/H/0838/001 Portugal 2588382 Sporanox 10mg/ml solução oral 00242/0307 Sporanox LiquidIE/H/0805/003 Portugal 2595189 Telfast 180mg comprimidos revestidos por pelicula 04425/0158 Telfast 180mg tabsSE/H/1821/001 Portugal 2627883 Nasomet 50 microgramas/pulverização, suspensão para pulverização nasal 00025/0587 Nasonex 50ug/actuation nasal sprayPT/H/2348/001 Portugal 2638682 FemSete 50 49876/0007 FemSeven 50ug/24hr patchPT/H/2348/001 Portugal 2638781 FemSete 50 49876/0007 FemSeven 50ug/24hr patchSE/H/0565/001 Portugal 2644383 Co-Diovan 80 mg /12,5 mg comprimidos revestidos por película 00101/0480 Co-Diovan 80/12.5mg tabsSE/H/0565/001 Portugal 2644482 Co-Diovan 80 mg /12,5 mg comprimidos revestidos por película 00101/0480 Co-Diovan 80/12.5mg tabsSE/H/0565/001 Portugal 2644581 Co-Diovan 80 mg /12,5 mg comprimidos revestidos por película 00101/0480 Co-Diovan 80/12.5mg tabsDK/H/3015/001 Portugal 2645281 Alphagan 0.2% p/v colirio, solucao 00426/0088 Alphagan 2mg/ml eye dropsNL/H/0144/002 Portugal 2716181 Maxalt 10mg comprimidos 00025/0370 Maxalt 10mg tabsDE/H/4690/002 Portugal 2734382 Triapin 5mg+5mg comprimidos de libertação prolongada 04425/0320 Triapin 5mg/5mg PR tabsDE/H/4690/002 Portugal 2734887 Triapin 5mg+5mg comprimidos de libertação prolongada 04425/0320 Triapin 5mg/5mg PR tabsSE/H/0147/001 Portugal 2798486 Cerazette 75 microgramas comprimidos revestidos por película 00025/0562 Cerazette 75mcg tabsSE/H/0147/001 Portugal 2798585 Cerazette 75 microgramas comprimidos revestidos por película 00025/0562 Cerazette 75mcg tabsIE/H/0107/001 Portugal 2805489 Celluvisc 1,0%, colirio, solucao 41443/0001 Celluvisc 1% eye dropsNL/H/4790/001 Portugal 2871184 Zanicor 10mg comprimido revestido por pelicula 04595/0005 Zanidip 10mg tabsNL/H/0150/001 Portugal 2871382 Implanon NXT 00025/0563 NexplanonSE/H/0169/001 Portugal 2874386 Seretaide 50/100 Diskus 10949/0314 Seretide 100 AccuhalerSE/H/0169/002 Portugal 2874683 Seretaide 50/250 Diskus 10949/0315 Seretide 250 AccuhalerSE/H/0169/003 Portugal 2874980 Seretaide 50/500 Diskus 10949/0316 Seretide 500 AccuhalerPT/H/2363/001 Portugal 2922482 Augmentin Duo 400mg/57mg/5ml, pó para suspensão oral 10592/0070 Augmentin Duo 400/57PT/H/2396/001 Portugal 2971588 Xilopar 1,25mg liofilizado oral 16260/0031 Zelapar 1.25mg lyophilisatesNL/H/0156/003 Portugal 3073589 Seroquel 200mg comprimidos revestidos 50827/0004 Seroquel 200mg tabsNL/H/0156/002 Portugal 3074580 Seroquel 100mg comprimidos revestidos 50827/0003 Seroquel 100mg tabsDK/H/0134/001 Portugal 3085289 Cosopt 20mg/ml + 5mg/ml, colirio, solucao 16058/0016 Cosopt solutionIE/H/0716/002 Portugal 3090685 Zoref 250mg/5mL granulado para suspensão oral 10949/0272 Zinnat 250mg/5ml suspensionNL/H/1458/003 Portugal 3124989 Fortzaar 100mg+25mg comprimidos revestidos por pelicula 00025/0374 Cozaar Comp 100mg/25mgSE/H/0110/007 Portugal 3221496 Topamax 15mg cápsulas 00242/0348 Topamax Sprinkle 15mg capsSE/H/0110/008 Portugal 3221694 Topamax 25mg cápsulas 00242/0349 Topamax Sprinkle 25mg capsSE/H/0110/009 Portugal 3221793 Topamax 50mg cápsulas 00242/0350 Topamax Sprinkle 50mg capsNL/H/2280/001 Portugal 3401981 Femoston 1/5 comprimidos revestidos por pelicula 46302/0038 Femoston-Conti 1mg/5mg tabsSE/H/0110/001 Portugal 3480795 Topamax 25mg 00242/0301 Topamax 25mg tabsSE/H/0110/001 Portugal 3480894 Topamax 25mg 00242/0301 Topamax 25mg tabs

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductSE/H/0110/002 Portugal 3481090 Topamax 50mg 00242/0302 Topamax 50mg tabsDE/H/5770/002 Portugal 3512787 Seretaide Inalador 25/125 microgramas/dose Suspensao pressurizada para inalacao 10949/0338 Seretide 125 EvohalerDE/H/5770/003 Portugal 3512886 Seretaide Inalador 25 microgramas / 250 microgramas / dose Suspensao pressurizada10949/0339 Seretide 250 EvohalerSE/H/0229/001 Portugal 3513587 Symbicort Turbohaler 160/4.5 17901/0092 Symbicort 200/6 TurbohalerSE/H/0229/001 Portugal 3514080 Symbicort Turbohaler 160/4.5 17901/0092 Symbicort 200/6 TurbohalerSE/H/0230/001 Portugal 3515087 Symbicort Turbohaler 80/4.5 17901/0091 Symbicort 100/6 TurbohalerSE/H/0225/001 Portugal 3520186 Zaditen 0,25 mg/ml colírio, solução 20162/0019 Zaditen 0.25mg/ml eye dropsSE/H/0249/001 Portugal 3692282 Xalacom 00057/1056 Xalacom eye dropsNL/H/0265/001 Portugal 3694981 Nuvaring 0.120mg/0.015mg por 24 horas Sistema de Libertacao vaginal 00025/0565 NuvaRingDE/H/0299/001 Portugal 3732088 Xyzal 5mg comprimidos revestidos por película 00039/0539 Xyzal 5mg tabsNL/H/0156/007 Portugal 3734787 Seroquel 300mg comprimidos revestidos 50827/0005 Seroquel 300mg tabsSE/H/0406/003 Portugal 3787488 Diovan 80mg comprimidos revestidos por película 00101/0600 Diovan 80mg tabsSE/H/0406/003 Portugal 3787587 Diovan 80mg comprimidos revestidos por película 00101/0600 Diovan 80mg tabsSE/H/0406/004 Portugal 3787884 Diovan 160mg comprimidos revestidos por película 00101/0601 Diovan 160mg tabsSE/H/0406/004 Portugal 3804184 Diovan 160mg comprimidos revestidos por película 00101/0601 Diovan 160mg tabsSE/H/1421/002 Portugal 3818481 Estradot 50micrograms/24horas, sistema transdermico 00101/0643 Estradot 50ug/24hDK/H/0279/001 Portugal 3872686 Daivobet 50 microgramas/0,5 mg/g pomada 05293/0003 Dovobet ointmentDE/H/0307/001 Portugal 3887882 Transtec 35 microgramas/h Sistema transdérmico 04539/0014 Transtec 35ug/hr patchDE/H/0307/001 Portugal 3887981 Transtec 35 microgramas/h Sistema transdérmico 04539/0014 Transtec 35ug/hr patchDE/H/0307/002 Portugal 3888187 Transtec 52,5 microgramas/h Sistema transdérmico 04539/0015 Transtec 52.5ug/hr patchDE/H/0307/002 Portugal 3888286 Transtec 52,5 microgramas/h Sistema transdérmico 04539/0015 Transtec 52.5ug/hr patchDE/H/0307/003 Portugal 3888484 Transtec 70 microgramas/h Sistema transdérmico 04539/0016 Transtec 70ug/hr patchDE/H/0307/003 Portugal 3888583 Transtec 70 microgramas/h Sistema transdérmico 04539/0016 Transtec 70ug/hr patchNL/H/1457/003 Portugal 3982782 Cozaar 100mg comprimidos revestidos por película 00025/0416 Cozaar 100mg tabsNL/H/0299/001 Portugal 3984481 Spiriva 18 microgramas, po para inalacao 14598/0062 Spiriva 18mcg inhalation powderFI/H/0989/0001 Portugal 4041786 Oftaquix 5mg/ml colirio, solucao 16058/0006 Oftaquix 5mg/ml eye dropsSE/H/0229/002 Portugal 4073680 Symbicort Turbohaler 320/9 17901/0200 Symbicort 400/12 TurbohalerPT/H/2299/003 Portugal 4106282 Arcoxia 120mg comprimidos revestidos por pelicula 00025/0644 Arcoxia 120mg tabsPT/H/2299/001 Portugal 4108080 Arcoxia 60mg comprimidos revestidos por pelicula 00025/0642 Arcoxia 60mg tabsPT/H/2299/002 Portugal 4109484 Arcoxia 90mg comprimidos revestidos por pelicula 00025/0643 Arcoxia 90mg tabsDE/H/6007/001 Portugal 4260881 Concerta 18mg comprimidos de libertacao prolongada 00242/0372 Concerta XL 18mg tabsDE/H/6007/002 Portugal 4261087 Concerta 36mg comprimidos de libertacao prolongada 00242/0373 Concerta XL 36mg tabsDE/H/6007/003 Portugal 4261285 Concerta 54mg comprimidos de libertacao prolongada 00242/0374 Concerta XL 54mg tabsSE/H/0936/002 Portugal 4273082 Efexor XR 75mg capsulas de libertacao prolongada 50622/0020 Efexor XL 75mg capsSE/H/0936/003 Portugal 4273181 Efexor XR 150mg capsulas de libertacao prolongada 00057/1281 Efexor XL 150mg capsNL/H/4790/002 Portugal 4339685 Zanicor 20mg comprimido revestido por pelicula 04595/0010 Zanidip 20mg tabsNL/H/0343/001 Portugal 4357281 Crestor 10mg comprimidos revestidos por pelicula 17901/0201 Crestor 10mg tabsNL/H/0343/002 Portugal 4358388 Crestor 20mg comprimidos revestidos por pelicula 17901/0202 Crestor 20mg tabsDE/H/0396/001 Portugal 4367587 Ezetrol 10 mg Comprimidos 00025/0609 Ezetrol 10mg tabsDE/H/0396/001 Portugal 4367785 Ezetrol 10 mg Comprimidos 00025/0609 Ezetrol 10mg tabsDE/H/0769/002 Portugal 4655783 Lopiretic comprimidos 00034/0263 Capozide tabsDE/H/0384/001 Portugal 4728689 Olmetec 10mg comprimidos revestidos por película 08265/0015 Olmetec 10mg tabsDE/H/0384/002 Portugal 4729083 Olmetec 20mg comprimidos revestidos por película 08265/0016 Olmetec 20mg tabsDE/H/0384/002 Portugal 4729281 Olmetec 20mg comprimidos revestidos por película 08265/0016 Olmetec 20mg tabsDE/H/0384/003 Portugal 4729489 Olmetec 40mg comprimidos revestidos por película 08265/0017 Olmetec 40mg tabsDE/H/0384/003 Portugal 4729687 Olmetec 40mg comprimidos revestidos por película 08265/0017 Olmetec 40mg tabsSE/H/0565/002 Portugal 4804787 Co-Diovan 160 mg /12,5 mg comprimidos revestidos por película 00101/0650 Co-Diovan 160/12.5mg tabsSE/H/0565/002 Portugal 4804886 Co-Diovan 160 mg /12,5 mg comprimidos revestidos por película 00101/0650 Co-Diovan 160/12.5mg tabs

Version: 11/11/2020 Page: 54 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductSE/H/0560/001 Portugal 5027446 Glucomed 625mg Comprimidos 32383/0001 Alateris 625mg tabsSE/H/0581/001 Portugal 5058250 Zarelix 37.5mg comprimidos de libertação prolongada 01883/0338 Venlalic XL 37.5mg tabsSE/H/0581/002 Portugal 5058276 Zarelix 75mg comprimidos de libertação prolongada 01883/0339 Venlalic XL 75mg tabsSE/H/0581/003 Portugal 5058318 Zarelix 150mg comprimidos de libertação prolongada 01883/0340 Venlalic XL 150mg tabsSE/H/0581/004 Portugal 5058334 Zarelix 225mg comprimidos de libertação prolongada 01883/0341 Venlalic XL 225mg tabsNL/H/0945/001 Portugal 5058557 Azitromicina Teva 40mg/ml po para suspensao oral 00289/0973 Azithromycin Teva 200mg/5ml powderDK/H/0134/002 Portugal 5077722 Cosopt Recipiente unidose,20mg/ml + 5mg/ml,colirio,solucao 16058/0015 Cosopt SDUDE/H/0957/003 Portugal 5080924 Ropinirol Mylan 1mg 04569/0814 Ropinirole 1mg film-coated tabsDE/H/0957/004 Portugal 5080932 Ropinirol Mylan 2mg 04569/0815 Ropinirole 2mg film-coated tabsNL/H/0156/008 Portugal 5085212 Seroquel SR 50mg comprimidos de libertação prolongada 50827/0006 Seroquel XL 50mg tabsNL/H/0156/009 Portugal 5085220 Seroquel SR 200mg comprimidos de libertação prolongada 50827/0008 Seroquel XL 200mg tabsNL/H/0156/009 Portugal 5085238 Seroquel SR 200mg comprimidos de libertação prolongada 50827/0008 Seroquel XL 200mg tabsNL/H/0156/010 Portugal 5085246 Seroquel SR 300mg comprimidos de libertação prolongada 50827/0009 Seroquel XL 300mg tabsNL/H/0156/010 Portugal 5085253 Seroquel SR 300mg comprimidos de libertação prolongada 50827/0009 Seroquel XL 300mg tabsNL/H/0156/011 Portugal 5085261 Seroquel SR 400mg comprimidos de libertação prolongada 50827/0010 Seroquel XL 400mg tabsIT/H/0774/001 Portugal 5097787 Lyrinel 5mg comprimidos de libertacao prolongada 00242/0385 Lyrinel XL 5mg tabsNL/H/0718/001 Portugal 5114111 Spiriva Respimat 2,5ug, solucao para inalacao por nebulizacao 14598/0084 Spiriva RespimatDE/H/0957/003 Portugal 5132733 Ropinirol Mylan 1mg 04569/0814 Ropinirole 1mg film-coated tabsDK/H/0279/002 Portugal 5146402 Daivobet 50 microgramas/0,5mg/g Gel 05293/0005 Dovobet gelDK/H/0279/002 Portugal 5146410 Daivobet 50 microgramas/0,5mg/g Gel 05293/0005 Dovobet gelNL/H/0156/008 Portugal 5178165 Seroquel SR 50mg comprimidos de libertação prolongada 50827/0006 Seroquel XL 50mg tabsDE/H/0991/002 Portugal 5193149 Saflutan 15 microgramas/ml colirio 16058/0017 Saflutan 15ug/ml eye dropsDE/H/6007/004 Portugal 5205307 Concerta 27mg comprimidos de libertacao prolongada 00242/0400 Concerta XL 27mg tabsNL/H/0487/001 Portugal 5247887 Vesicare 5 mg comprimidos revestidos por película 00166/0197 Vesicare 5mg tabsNL/H/0487/002 Portugal 5248083 Vesicare 10mg comprimidos revestidos por película 00166/0198 Vesicare 10mg tabsDE/H/1913/001 Portugal 5259056 Lercanidipina Teva 10 mg comprimidos revestidos por película 00289/1283 Lercanidipine hydrochloride 10mg tabsDE/H/1913/002 Portugal 5259072 Lercanidipina Teva 20 mg comprimidos revestidos por película 00289/1284 Lercanidipine hydrochloride 20mg tabsPT/H/0622/001 Portugal 5270707 Omeprazol Azevedos 40mg Po para Solucao para Perfusao 24065/0002 Omeprazole 40mg powder for solnSE/H/0565/003 Portugal 5273487 Co-Diovan 160 mg /25 mg comprimidos revestidos por película 00101/0651 Co-Diovan 160/25mg tabsDE/H/5733/001 Portugal 5281472 Vessatis 700mg emplastro medicamentoso 21727/0016 Versatis 700mg medicated plasterDE/H/5733/001 Portugal 5281514 Vessatis 700mg emplastro medicamentoso 21727/0016 Versatis 700mg medicated plasterDE/H/2251/001 Portugal 5286562 Combodart 0,5mg/0,4mg cápsulas 19494/0046 Combodart 0.5mg/0.4mg capsDE/H/2251/001 Portugal 5286570 Combodart 0,5mg/0,4mg cápsulas 19494/0046 Combodart 0.5mg/0.4mg capsNL/H/1540/001 Portugal 5291695 Lamictal 25mg comprimido 00003/0272 Lamictal 25mg tabsNL/H/1540/001 Portugal 5291794 Lamictal 25mg comprimido 00003/0272 Lamictal 25mg tabsNL/H/1540/002 Portugal 5291885 Lamictal 50mg comprimido 00003/0273 Lamictal 50mg tabsDK/H/2871/001 Portugal 5295068 Picoprep 03194/0014 PicolaxDK/H/2871/001 Portugal 5327630 Picoprep 03194/0014 PicolaxDE/H/2020/004 Portugal 5334420 Palexia retard 50mg comprimidos de libertação prolongada 21727/0041 Palexia SR 50mg tabsDE/H/2020/004 Portugal 5334438 Palexia retard 50mg comprimidos de libertação prolongada 21727/0041 Palexia SR 50mg tabsDE/H/2020/005 Portugal 5334461 Palexia retard 100mg comprimidos de libertação prolongada 21727/0042 Palexia SR 100mg tabsDE/H/2020/006 Portugal 5334511 Palexia retard 150mg comprimidos de libertação prolongada 21727/0043 Palexia SR 150mg tabsDE/H/2020/007 Portugal 5334545 Palexia retard 200mg comprimidos de libertação prolongada 21727/0044 Palexia SR 200mg tabsDE/H/2020/008 Portugal 5334578 Palexia retard 250mg comprimidos de libertação prolongada 21727/0045 Palexia SR 250mg tabsIE/H/0165/002 Portugal 5335161 Prograf 1mg capsulas 00166/0203 Prograf 1mg hard capsIE/H/0165/001 Portugal 5345913 Prograf 0,5mg Capsulas 00166/0206 Prograf 0.5mg hard capsDE/H/0523/003 Portugal 5350236 Olmetec Plus 40mg+12,5mg comprimidos revestidos por película 08265/0029 Olmetec Plus 40mg/12.5mg tabsDE/H/0523/004 Portugal 5350251 Olmetec Plus 40mg+25mg comprimidos revestidos por película 08265/0030 Olmetec Plus 40mg/25mg tabs

Version: 11/11/2020 Page: 55 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductDE/H/5609/001 Portugal 5441654 Binosto 70 mg comprimidos efervescentes 40861/0006 Binosto 70mg effervescent tabsDK/H/2028/001 Portugal 5444351 Metilfenidato Sandoz 18mg Comprimidos de Libertação Prolongada 04416/1346 Matoride XL 18mg tabsDK/H/2028/002 Portugal 5444377 Metilfenidato Sandoz 36mg Comprimidos de Libertação Prolongada 04416/1348 Matoride XL 36mg tabsDK/H/2028/003 Portugal 5444419 Metilfenidato Sandoz 54mg Comprimidos de Libertação Prolongada 04416/1349 Matoride XL 54mg tabsSE/H/0406/005 Portugal 5448980 Diovan 40mg comprimidos revestidos por película 00101/0599 Diovan 40mg tabsNL/H/0156/012 Portugal 5456033 Seroquel SR 150mg comprimidos de libertação prolongada 50827/0007 Seroquel XL 150mg tabsSE/H/1921/001 Portugal 5488226 Flutiform 50 microgramas/5 microgramas suspensão pressurizada para inalação 16950/0167 Flutiform 50mcg/5mcg inhalerSE/H/1921/002 Portugal 5488234 Flutiform 125 microgramas/5 microgramas suspensão pressurizada para inalação 16950/0168 Flutiform 125mcg/5mcg inhalerSE/H/1921/003 Portugal 5488242 Flutiform 250 microgramas/10 microgramas suspensão pressurizada para inalação 16950/0169 Flutiform 250mcg/10mcg inhalerFI/H/0313/001 Portugal 5490057 Nebido 1000mg/4ml solução injetável 00010/0549 Nebido 1000mg/4ml injNL/H/0343/004 Portugal 5569488 Crestor 5mg comprimidos revestidos por pelicula 17901/0243 Crestor 5mg tabsFI/H/0981/001 Portugal 5572383 Tobradex 3 mg/ ml/ 1mg/ml Colírio, Suspensão 00101/1007 Tobradex eye dropsDK/H/0784/001 Portugal 5579081 Sevoflurano Baxter 100%, Líquido para inalação por vaporização 00116/0420 Sevoflurane Baxter inhalation vapourFR/H/0070/002 Portugal 5588082 Trusopt 4mg/0,2ml colírio solução recipient unidose 16058/0013 Trusopt SDUDE/H/3355/001 Portugal 5596648 Dymista 137 microgramas / 50 microgramas por aplicação Suspensão para pulverizaçã15142/0258 Dymista Nasal SpraySE/H/0643/002 Portugal 5618418 Metex 7,5mg injeksjonsvaeske,opplosning i ferdigfylt penn 11587/0076 Metoject Pen 7.5mgSE/H/0643/005 Portugal 5618541 Metex Pen 15mg Injektionslösung im Fertigpen 11587/0079 Metoject Pen 15mgSE/H/0643/006 Portugal 5618673 Metex 17.5mg injeksjonsvaeske,opplosning i ferdigfylt penn 11587/0080 Metoject Pen 17.5mgSE/H/0643/011 Portugal 5618822 Metex Pen 30mg Injektionslösung im Fertigpen 11587/0085 Metoject Pen 30mgSE/H/0643/008 Portugal 5618962 Metex 22.5mg injeksjonsvaeske,opplosning i ferdigfylt penn 11587/0082 Metoject Pen 22.5mgSE/H/0643/007 Portugal 5619119 Metex Pen 20mg Injektionslösung im Fertigpen 11587/0081 Metoject Pen 20mgSE/H/0643/004 Portugal 5619242 Metex 12.5mg injeksjonsvaeske,opplosning i ferdigfylt penn 11587/0078 Metoject Pen 12.5mgSE/H/0643/010 Portugal 5619374 Metoject PEN 27.5mg=0,55ml oplossing voor injectie in een voorgevulde pen 11587/0084 Metoject Pen 27.5mgSE/H/0643/003 Portugal 5619523 Metex Pen 10mg Injektionslösung im Fertigpen 11587/0077 Metoject Pen 10mgSE/H/0643/009 Portugal 5619655 Metex Pen 25mg Injektionslösung im Fertigpen 11587/0083 Metoject Pen 25mgNL/H/1458/002 Portugal 5627781 Cozaar Plus 100mg+12.5mg comprimidos revestidos por pelicula 00025/0473 Cozaar Comp 100mg/12.5mgES/H/0653/001 Portugal 5687652 Braltus 10 microgramas por dose libertada, po para inhalacao capsula 00289/1870 Braltus 10mcg inhalation powderES/H/0654/001 Portugal 5687660 Gregal 10 microgramas por dose libertada, po para inhalacao capsula 00289/1957 Gregal 10mcg inhalation powderDE/H/6220/001 Portugal 5692587 Malarone 250 mg/100 mg comprimidos revestidos por película 10949/0258 Malarone tabsNL/H/0653/001 Portugal 5692785 Dexafree 1mg/ml colirio solucao 20162/0013 Dexafree 1mg/ml eye dropsDE/H/5724/001 Portugal 5699822 Serkep 25 microgramas + 125 microgramas por dose calibrada 04569/1449 Sirdupla 25/125mcg inhalerDE/H/5724/002 Portugal 5699830 Serkep 25 microgramas + 250 microgramas por dose calibrada 04569/1450 Sirdupla 25/250mcg inhalerAT/H/0983/003 Portugal 5709688 Aricept 5mg comprimidos orodispersiveis 10555/0019 Aricept Evess 5mg oprodispersible tabsAT/H/0983/004 Portugal 5709787 Aricept 10mg comprimidos orodispersiveis 10555/0020 Aricept Evess 10mg orodispersible tabsAT/H/0983/003 Portugal 5715883 Aricept 5mg comprimidos orodispersiveis 10555/0019 Aricept Evess 5mg oprodispersible tabsAT/H/0983/004 Portugal 5716188 Aricept 10mg comprimidos orodispersiveis 10555/0020 Aricept Evess 10mg orodispersible tabsNL/H/0265/001 Portugal 5717756 Nuvaring 0.120mg/0.015mg por 24 horas Sistema de Libertacao vaginal 00025/0565 NuvaRingFR/H/0272/003 Portugal 5724083 Tridural 300mg comprimidos de libertação prolongada 43808/0003 Tradorec XL 300mg tabsFR/H/0272/002 Portugal 5724182 Tridural 200mg comprimidos de libertação prolongada 43808/0002 Tradorec XL 200mg tabsFR/H/0272/001 Portugal 5724281 Tridural 100mg comprimidos de libertação prolongada 43808/0001 Tradorec XL 100mg tabs

NL/H/3915/001 Portugal 5738398 Durogesic 12 microgramas/hora sistema transdérmico 00242/0409 Durogesic DTrans 12ug/hrSE/H/0304/001 Portugal 5744289 Avodart 0.5mg capsulas moles 19494/0006 Avodart 0.5mg soft capsDK/H/0134/003 Portugal 5750062 Cosopt iMulti 20mg/ml + 5mg/ml colírio, solução 16058/0025 Cosopt iMultiIE/H/0716/004 Portugal 5811187 Zoref 250mg comprimidos revestidos por película 10949/0096 Zinnat 250mg tabsIE/H/0716/005 Portugal 5811286 Zoref 500mg comprimidos revestidos por película 10949/0119 Zinnat 500mg tabsSE/H/0560/001 Portugal 5820386 Glucomed 625mg Comprimidos 32383/0001 Alateris 625mg tabsDE/H/0523/001 Portugal 5910989 Olmetec Plus 20mg+12,5mg comprimidos revestidos por película 08265/0022 Olmetec Plus 20mg/12.5mg tabsDE/H/0523/001 Portugal 5911185 Olmetec Plus 20mg+12,5mg comprimidos revestidos por película 08265/0022 Olmetec Plus 20mg/12.5mg tabs

Version: 11/11/2020 Page: 56 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductDE/H/0523/002 Portugal 5911383 Olmetec Plus 20mg+25mg comprimidos revestidos por película 08265/0023 Olmetec Plus 20mg/25mg tabsDE/H/0523/002 Portugal 5911581 Olmetec Plus 20mg+25mg comprimidos revestidos por película 08265/0023 Olmetec Plus 20mg/25mg tabsFR/H/0288/001 Portugal 5932082 Timogel 1 mg/g Gel oftálmico em recipiente unidose 20162/0010 Tiopex 1mg/g eye gel SDUSE/H/0404/002 Portugal 8589523 Renitec 5mg comprimidos 00025/0194 Innovace 5mg tabsDE/H/5237/002 Portugal 8605915 Haldol Decanoato 100 mg/ml Solucao Injectavel 00242/0095 Haldol decanoate 100mg/ml injDE/H/4019/005 Portugal 8611400 Sandimmun Neoral 100mg/ml solução oral 00101/0390 Neoral 100mg/ml solutionDE/H/0769/002 Portugal 8681726 Lopiretic comprimidos 00034/0263 Capozide tabsSE/H/0527/002 Portugal 8708206 Zestril-5 17901/0061 Zestril 5mg tabsSE/H/0527/002 Portugal 8708214 Zestril-5 17901/0061 Zestril 5mg tabsSE/H/0527/004 Portugal 8708230 Zestril 20mg comprimidos 17901/0063 Zestril 20mg tabsDE/H/4019/002 Portugal 8742700 Sandimmun Neoral 25mg cápsulas moles 00101/0387 Neoral 25mg soft capsDE/H/4019/002 Portugal 8742718 Sandimmun Neoral 25mg cápsulas moles 00101/0387 Neoral 25mg soft capsDE/H/4019/004 Portugal 8742726 Sandimmun Neoral 100mg cápsulas moles 00101/0389 Neoral 100mg soft capsDE/H/4019/003 Portugal 8742767 Sandimmun Neoral 50mg cápsulas moles 00101/0388 Neoral 50mg soft capsIE/H/0716/001 Portugal 8780700 Zoref 125mg/5mL granulado para suspensão oral 10949/0094 Zinnat 125mg/5ml suspensionDE/H/6015/002 Romania 10957/2018/01-02 Duac 10mg/g + 30mg/g Gel 19494/0251 Duac Once Daily 10+30mg/g GelDK/H/0134/003 Romania 11102/2018/01 Cosopt fara conservant 20mg/ml+5mg/ml picături oftalmice, soluţie 16058/0025 Cosopt iMultiDE/H/0116/001 Romania 1264/2008/01 Lescol 20mg 00101/0360 Lescol 20mg capsDE/H/0116/002 Romania 1265/2008/01 Lescol 40mg 00101/0361 Lescol 40mg capsSE/H/0643/001 Romania 1278/2008/01-100 Metoject 50 mg/ml solutie injectabila in seringa preumpluta 11587/0046 Metoject 50mg/ml soln for injNL/H/1230/001 Romania 1282/2008 Qlaira, comprimate filmate 00010/0576 Qlaira tabsDE/H/0116/003 Romania 1297/2008/01 Lescol XL 80mg 00101/0587 Lescol XL 80mg tabsSE/H/0304/001 Romania 1318/2008/02 Avodart 0,5 mg capsule moi 19494/0006 Avodart 0.5mg soft capsNL/H/1540/001 Romania 1742/2009/03 Lamictal 25mg comprimate 00003/0272 Lamictal 25mg tabsNL/H/1540/002 Romania 1743/2009/02 Lamictal 50mg comprimate 00003/0273 Lamictal 50mg tabsNL/H/1540/003 Romania 1744/2009/01-10 Lamictal 100mg comprimate 00003/0274 Lamictal 100mg tabsSE/H/0278/002 Romania 206/2007/08 Cipralex 10mg comprimate filmate 13761/0009 Cipralex 10mg tabsPT/H/2363/001 Romania 2451/2010/01-04 Augmentin BIS 400mg/57mg/5ml pulbere pentru suspensie orală 10592/0070 Augmentin Duo 400/57DK/H/2871/001 Romania 2628/2010/01 Picoprep 03194/0014 PicolaxNL/H/4823/001 Romania 2634/2010/01-08 Exemestan Teva comprimate filmate 00289/1498 Exemestane Teva 25mg tabsDE/H/2251/001 Romania 2641/2010/01 Duodart 0.5/0.4mg capsule 19494/0046 Combodart 0.5mg/0.4mg capsDE/H/2251/001 Romania 2641/2010/02 Duodart 0.5/0.4mg capsule 19494/0046 Combodart 0.5mg/0.4mg capsDE/H/2251/001 Romania 2641/2010/03 Duodart 0.5/0.4mg capsule 19494/0046 Combodart 0.5mg/0.4mg capsDE/H/0109/003 Romania 2951/2010/01 Sortis 40mg comprimate filmate 50622/0041 Lipitor 40mg tabsNL/H/1457/001 Romania 2976/2010 Cozaar 12.5mg comprimate filmate 00025/0515 Cozaar 12.5mg tabsNL/H/1457/002 Romania 2977/2010 Cozaar 50mg comprimate filmate 00025/0324 Cozaar 50mg tabsDE/H/0116/003 Romania 3020/2002/01 Lescol XL 80mg 00101/0587 Lescol XL 80mg tabsSE/H/0229/001 Romania 3168/2011/01 Symbicort Turbuhaler 160 micrograme/4,5 micrograme/inhalatie, pulbere de inhalat 17901/0092 Symbicort 200/6 TurbohalerSE/H/0229/002 Romania 3169/2011/01 Symbicort Turbuhaler 320 micrograme/9 micrograme/inhalatie, pulbere de inhalat 17901/0200 Symbicort 400/12 TurbohalerSE/H/0211/004 Romania 3268/2011/01 Nexium 10 mg granule gastrorezistente pentru suspensie orala, plic 17901/0253 Nexium 10mg granulesDE/H/2020/004 Romania 3282/2011/01-24 Palexia retard 50mg comprimate cu eliberare prelungită 21727/0041 Palexia SR 50mg tabsDE/H/2020/005 Romania 3283/2011/01-24 Palexia retard 100mg comprimate cu eliberare prelungită 21727/0042 Palexia SR 100mg tabsDE/H/2020/006 Romania 3284/2011/01-24 Palexia retard 150mg comprimate cu eliberare prelungită 21727/0043 Palexia SR 150mg tabsDE/H/2020/007 Romania 3285/2011/01-24 Palexia retard 200mg comprimate cu eliberare prelungită 21727/0044 Palexia SR 200mg tabsDE/H/2020/008 Romania 3286/2011/01-24 Palexia retard 250mg comprimate cu eliberare prelungită 21727/0045 Palexia SR 250mg tabsPT/H/1945/002 Romania 3412/2011/04 Gabapentin Aurobindo 300mg capsule 16363/0286 Gabapentin Aurobindo 300mg capsSE/H/0936/002 Romania 3455/2011/ Efectin EP 75mg 50622/0020 Efexor XL 75mg capsSE/H/0936/003 Romania 3456/2011/ Efectin EP 150mg 00057/1281 Efexor XL 150mg caps

Version: 11/11/2020 Page: 57 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductNL/H/0299/001 Romania 3790/2011/02 Spiriva 18 micrograme capsule cu pulbere de inhalat 14598/0062 Spiriva 18mcg inhalation powderSE/H/0406/005 Romania 3945/2011 Diovan 40mg comprimate filmate 00101/0599 Diovan 40mg tabsSE/H/0406/003 Romania 3946/2011 Diovan 80mg comprimate filmate 00101/0600 Diovan 80mg tabsSE/H/0406/004 Romania 3947/2011 Diovan 160mg comprimate filmate 00101/0601 Diovan 160mg tabsDE/H/3456/005 Romania 4067/2011/01 Diflucan 10mg/ml powder for oral suspension 00057/0343 Diflucan 10mg/ml oral suspensionDK/H/0279/002 Romania 4500/2012 Daivobet 50 micrograme/0,5mg/g gel 05293/0005 Dovobet gelNL/H/0732/001 Romania 4793/2012/01-02 Mezavant 1200mg comprimate gastrorezistente cu eliberare prelungită 08081/0040 Mezavant XL 1200mg tabsNL/H/0265/001 Romania 4823/2012/01 NuvaRing 0,120mg/0,015mg per 24 de ore system cu cedare vaginală 00025/0565 NuvaRingDE/H/2020/009 Romania 4905/2012/01-24 Palexia retard 25mg comprimate cu eliberare prelungită 21727/0051 Palexia SR 25mg tabsFR/H/0110/001 Romania 5026/2012/01 Femara 2,5mg comprimate filmate 00101/0493 Femara 2.5mg tabsFR/H/0130/004 Romania 516/2008/04 Noliprel Arg Forte 5mg/1.25mg comprime filmate 05815/0052 Coversyl Arginine Plus 5/1.25mg tabsIE/H/0638/001 Romania 5163/2012/01 Norvasc 5mg comprimate 50622/0033 Istin 5mg tabsNL/H/2038/001 Romania 5229/2012/02 Mometazone furoat Sandoz 50 microgramme/doza spray nazal, suspensie 04416/1236 Mometasone Furoate 50mcg nasal sprayNL/H/1732/002 Romania 5274/2005/01 Zoloft 50mg 00057/0308 Lustral 50mg tabsNL/H/1732/003 Romania 5275/2005/01 Zoloft 100mg 00057/0309 Lustral 100mg tabsDE/H/3355/001 Romania 5574/2013/01 Dymista 137 micrograme/50 micrograme/doza spray nazal, suspensie 15142/0258 Dymista Nasal SprayDE/H/3355/001 Romania 5574/2013/03 Dymista 137 micrograme/50 micrograme/doza spray nazal, suspensie 15142/0258 Dymista Nasal SprayNL/H/0718/001 Romania 5642/2013/04 Spiriva Respimat 2,5 micrograme soluţie de inhalat 14598/0084 Spiriva RespimatIE/H/0638/001 Romania 5654/2013/01-16 Norvasc 5mg comprimate 50622/0033 Istin 5mg tabsIE/H/0638/002 Romania 5655/2013/01-17 Norvasc 10mg comprimate 50622/0031 Istin 10mg tabsDE/H/6015/002 Romania 5658/2013/01-02 Duac 10mg/g + 30mg/g Gel 19494/0251 Duac Once Daily 10+30mg/g GelDE/H/5733/001 Romania 5736/2013/01-05 Versatis 700mg emplastru medicamentos 21727/0016 Versatis 700mg medicated plasterSE/H/0110/001 Romania 5932/2005/01 Topamax 25mg comprimate 00242/0301 Topamax 25mg tabsSE/H/0110/002 Romania 5933/2005/01 Topamax 50mg comprimate 00242/0302 Topamax 50mg tabsSE/H/0110/003 Romania 5934/2005/01 Topamax 100mg comprimate 00242/0303 Topamax 100mg tabsDE/H/4019/002 Romania 6023/2013/01 Sandimmun Neoral 25mg capsule moi 00101/0387 Neoral 25mg soft capsDE/H/4019/003 Romania 6024/2013/01 Sandimmun Neoral 50mg capsule moi 00101/0388 Neoral 50mg soft capsDE/H/4019/005 Romania 6025/2301/01 Sandimmun Neoral 100 mg/ml soluţie orală 00101/0390 Neoral 100mg/ml solutionNL/H/1458/001 Romania 6030/2013 Hyzaar 50mg/12,5mg comprimate filmate 00025/0338 Cozaar Comp 50mg/12.5mgNL/H/1458/003 Romania 6031/2013 Fortzaar 100mg/25mg, comprimate filmate 00025/0374 Cozaar Comp 100mg/25mgNL/H/0150/001 Romania 6256/2014/01 Nexplanon 68mg 00025/0563 NexplanonAT/H/0904/001 Romania 6459/2006/01 Arimidex 1mg comprimate filmate 17901/0002 Arimidex 1mg tabsSE/H/1821/001 Romania 6787/2014/01-02 Nasonex 50 micrograme/doză spray nazal, suspensie 00025/0587 Nasonex 50ug/actuation nasal sprayDE/H/2184/013 Romania 6876/2014/01 Rispolept Consta 25mg 00242/0375 Risperdal Consta 25mgDE/H/2184/014 Romania 6877/2014/01 Rispolept Consta 37.5mg 00242/0376 Risperdal Consta 37.5mgDE/H/2184/015 Romania 6878/2014/01 Rispolept Consta 50mg 00242/0377 Risperdal Consta 50mgNL/H/0156/002 Romania 7048/2014/01 Seroquel 100mg comprimate filmate 50827/0003 Seroquel 100mg tabsNL/H/0156/003 Romania 7049/2014/01 Seroquel 200mg comprimate filmate 50827/0004 Seroquel 200mg tabsSE/H/0230/001 Romania 7050/2014/01 Symbicort Turbuhaler 80/4.5 micrograme/inhalatie, pulbere de inhalat 17901/0091 Symbicort 100/6 TurbohalerSE/H/0229/001 Romania 7051/2014/01 Symbicort Turbuhaler 160 micrograme/4,5 micrograme/inhalatie, pulbere de inhalat 17901/0092 Symbicort 200/6 TurbohalerSE/H/0229/002 Romania 7052/2014/01 Symbicort Turbuhaler 320 micrograme/9 micrograme/inhalatie, pulbere de inhalat 17901/0200 Symbicort 400/12 TurbohalerAT/H/0904/001 Romania 7053/2014/01 Arimidex 1mg comprimate filmate 17901/0002 Arimidex 1mg tabsNL/H/0156/008 Romania 7125/2014/01-07 Seroquel XR 50mg comprimate cu eliberare prelungită 50827/0006 Seroquel XL 50mg tabsNL/H/0156/009 Romania 7126/2014/01-07 Seroquel XR 200mg comprimate cu eliberare prelungită 50827/0008 Seroquel XL 200mg tabsNL/H/0156/010 Romania 7127/2014/01-07 Seroquel XR 300mg comprimate cu eliberare prelungită 50827/0009 Seroquel XL 300mg tabsNL/H/0156/011 Romania 7128/2014/01-07 Seroquel XR 400mg comprimate cu eliberare prelungită 50827/0010 Seroquel XL 400mg tabsNL/H/0156/012 Romania 7223/2014/01-07 Seroquel XR 150mg comprimate cu eliberare prelungită 50827/0007 Seroquel XL 150mg tabsSE/H/0936/002 Romania 7585/2006/04 Efectin EP 75mg 50622/0020 Efexor XL 75mg caps

Version: 11/11/2020 Page: 58 of 67


Procedure No Source Country ECMA No Imported Name UK PL No UK ProductDE/H/2251/001 Romania 8163/2015/01 Duodart 0.5/0.4mg capsule 19494/0046 Combodart 0.5mg/0.4mg capsDE/H/2251/001 Romania 8163/2015/02 Duodart 0.5/0.4mg capsule 19494/0046 Combodart 0.5mg/0.4mg capsDE/H/2251/001 Romania 8163/2015/03 Duodart 0.5/0.4mg capsule 19494/0046 Combodart 0.5mg/0.4mg capsNL/H/0299/001 Romania 859/2008/05 Spiriva 18 micrograme capsule cu pulbere de inhalat 14598/0062 Spiriva 18mcg inhalation powderHU/H/0399/001 Romania 9371/2016/02 Dexametazona Krka 4mg comprimate 01656/0205 Dexamethasone 4mg tabsES/H/0653/001 Romania 9464/2016/02 Gregal 10 micrograme pulbere de inhalat capsulă 00289/1870 Braltus 10mcg inhalation powderDE/H/5733/001 Slovak Republic 01/0054/10-S Versatis 700mg liečivá náplasť 21727/0016 Versatis 700mg medicated plasterSE/H/0169/003 Slovak Republic 14/0012/17-S Seretide Disckus 50 mikrogramov/500 mikrogramov 10949/0316 Seretide 500 AccuhalerDE/H/0871/001 Slovak Republic 14/0110/07-S Foster 100/6 mikrogramov na inhaláciu inhalačný roztok v tlakovom obale 08829/0156 Fostair 100/6 inhalerDE/H/0528/001 Slovak Republic 14/0164/05-S Atimos 12 μg inhalačný roztok v tlakovom obale 08829/0154 Atimos ModuliteNL/H/0718/001 Slovak Republic 14/0315/07-S Spiriva Respimat 2,5 mikrogramov, inhalancy roztok 14598/0084 Spiriva RespimatSE/H/1921/003 Slovak Republic 14/0358/12-S Flutiform 250 mikrogramov /10 mikrogramov inhalacna suspenzia v tlakovom obale 16950/0169 Flutiform 250mcg/10mcg inhalerSE/H/1876/001 Slovak Republic 14/0402/06-S Serevent Inhaler N 10949/0369 Serevent 25 EvohalerNL/H/0299/001 Slovak Republic 14/0415/11-S Spiriva 18 mikrogramov, inhalačný prášok v tvrdej kapsule 14598/0062 Spiriva 18mcg inhalation powderDE/H/0871/002 Slovak Republic 14/0506/12-S Foster Nexthaler 100 mikrogramov/6 mikrogramov v dávke inhalačného prášku 08829/0173 Fostair Nexthaler 100/6SE/H/0230/001 Slovak Republic 14/0681/10-S Symbicort Turbuhaler 100 mikrogramov/6 mikrogramov/inhalácia 17901/0091 Symbicort 100/6 TurbohalerSE/H/0229/001 Slovak Republic 14/0682/10-S Symbicort Turbuhaler 200 mikrogramov/6 mikrogramov/inhalácia 17901/0092 Symbicort 200/6 TurbohalerSE/H/0229/002 Slovak Republic 14/0683/10-S Symbicort Turbuhaler 400 mikrogramov/12 mikrogramov/inhalácia 17901/0200 Symbicort 400/12 TurbohalerPT/H/2363/001 Slovak Republic 15/0005/00-S Augmentin Duo 400mg/57mg/5ml prášok na perorálnu suspenziu (jahodová príchuť) 10592/0070 Augmentin Duo 400/57IE/H/0715/001 Slovak Republic 15/0141/84-C/S Augmentin 375mg filmom obalené tablety 00038/0270 Augmentin 375mg tabsAT/H/0754/001 Slovak Republic 16/0033/02-S Clexane Forte 12000IU/0,8ml v naplnenej injekčnej striekačke 04425/0185 Clexane Forte 12000IU (120mg)/0.8mlAT/H/0754/002 Slovak Republic 16/0176/17-S Clexane Forte 15000IU/1ml v naplnenej injekčnej striekačke 04425/0185 Clexane Forte 15000IU (150mg)/1mlNL/H/0150/001 Slovak Republic 17/0011/08-S Implanon NXT 00025/0563 NexplanonNL/H/1540/002 Slovak Republic 21/0404/09-S Lamictal 50mg tablety 00003/0273 Lamictal 50mg tabsDE/H/3355/001 Slovak Republic 24/0055/13-S Dymista nosová aerodisperzia 137 mikrogramov / 50 mikrogramov v jednom vstreknutí 15142/0258 Dymista Nasal SprayDE/H/0299/001 Slovak Republic 24/0277/05-S Xyzal 5mg filmom obalene tablety 00039/0539 Xyzal 5mg tabsDE/H/6220/001 Slovak Republic 25/0127/06-S Malarone 250 mg/100 mg filmom obalené tablety 10949/0258 Malarone tabsSE/H/0908/001 Slovak Republic 41/0772/10-S Jext 150 mikrogramov 10085/0052 Jext 150mcg PenSE/H/0908/002 Slovak Republic 41/0773/10-S Jext 300 mikrogramov 10085/0053 Jext 300mcg PenFI/H/0313/001 Slovak Republic 56/0144/05-S Nebido 1000mg/4ml injekčný roztok 00010/0549 Nebido 1000mg/4ml injSE/H/0406/005 Slovak Republic 58/0080/05-S Diovan 40mg 00101/0599 Diovan 40mg tabsSE/H/0565/001 Slovak Republic 58/0153/01-S Co-Diovan 80 mg/12.5 mg filmom obalene tablety 00101/0480 Co-Diovan 80/12.5mg tabsSE/H/0406/003 Slovak Republic 58/0255/01-S Diovan 80mg 00101/0600 Diovan 80mg tabsSE/H/0406/004 Slovak Republic 58/0256/01-S Diovan 160mg 00101/0601 Diovan 160mg tabsSE/H/0565/002 Slovak Republic 58/0320/03-S Co-Diovan 160 mg/12.5 mg filmom obalene tablety 00101/0650 Co-Diovan 160/12.5mg tabsSE/H/0565/003 Slovak Republic 58/0321/03-S Co-Diovan 160 mg/25 mg filmom obalene tablety 00101/0651 Co-Diovan 160/25mg tabsDE/H/4019/005 Slovak Republic 59/0009/96-S Sandimmun Neoral 100mg/ml perorálny roztok 00101/0390 Neoral 100mg/ml solutionDE/H/4019/002 Slovak Republic 59/0010/96-S Sandimmun Neoral 25mg mäkké kapsuly 00101/0387 Neoral 25mg soft capsDE/H/4019/003 Slovak Republic 59/0010/96-S Sandimmun Neoral 50mg mäkké kapsuly 00101/0388 Neoral 50mg soft capsDE/H/4019/004 Slovak Republic 59/0010/96-S Sandimmun Neoral 100mg mäkké kapsuly 00101/0389 Neoral 100mg soft capsIE/H/0165/002 Slovak Republic 59/0117/00-S Prograf 1mg tvrde kapsuly 00166/0203 Prograf 1mg hard capsIE/H/0165/003 Slovak Republic 59/0118/00-S Prograf 5mg tvrde kapsuly 00166/0204 Prograf 5mg hard capsIE/H/0165/001 Slovak Republic 59/0132/08-S Prograf 0.5mg tvrde kapsuly 00166/0206 Prograf 0.5mg hard capsDK/H/2871/001 Slovak Republic 61/0393/10-S Picoprep 03194/0014 PicolaxDK/H/0134/002 Slovak Republic 64/0218/11-S Cosopt Free 16058/0015 Cosopt SDUDK/H/0134/003 Slovak Republic 64/0355/18-S Cosopt Multi Dose Free 20 mg/ml + 5 mg/ml očná roztoková instilácia 16058/0025 Cosopt iMultiDE/H/0991/002 Slovak Republic 64/0460/09-S Taflotan 15 mikrogramov/ml očná roztoková instilácia v jednodávkovom obale 16058/0017 Saflutan 15ug/ml eye dropsDE/H/2020/009 Slovak Republic 65/0225/12-S Palexia retard 25mg tablety s predĺženým uvoľňovaním 21727/0051 Palexia SR 25mg tabs

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductFR/H/0272/001 Slovak Republic 65/0400/05-S Noax uno 100 mg tablety s predĺženým uvoľňovaním 43808/0001 Tradorec XL 100mg tabsFR/H/0272/002 Slovak Republic 65/0401/05-S Noax uno 200 mg tablety s predĺženým uvoľňovaním 43808/0002 Tradorec XL 200mg tabsFR/H/0272/003 Slovak Republic 65/0402/05-S Noax uno 300 mg tablety s predĺženým uvoľňovaním 43808/0003 Tradorec XL 300mg tabs

DE/H/2020/004 Slovak Republic 65/0670/10-S Palexia retard 50mg tablety s predĺženým uvoľňovaním 21727/0041 Palexia SR 50mg tabsDE/H/2020/005 Slovak Republic 65/0671/10-S Palexia retard 100mg tablety s predĺženým uvoľňovaním 21727/0042 Palexia SR 100mg tabsDE/H/2020/006 Slovak Republic 65/0672/10-S Palexia retard 150mg tablety s predĺženým uvoľňovaním 21727/0043 Palexia SR 150mg tabsDE/H/2020/007 Slovak Republic 65/0673/10-S Palexia retard 200mg tablety s predĺženým uvoľňovaním 21727/0044 Palexia SR 200mg tabsDE/H/2020/008 Slovak Republic 65/0674/10-S Palexia retard 250mg tablety s predĺženým uvoľňovaním 21727/0045 Palexia SR 250mg tabsDE/H/2184/013 Slovak Republic 68/0105/03-S Risperdal Consta 25mg prášok a disperzné prostredie na intramuskulárnu injekčnú sus00242/0375 Risperdal Consta 25mgDE/H/2184/014 Slovak Republic 68/0106/03-S Risperdal Consta 37.5g prášok a disperzné prostredie na intramuskulárnu injekčnú sus00242/0376 Risperdal Consta 37.5mgDE/H/2184/015 Slovak Republic 68/0107/03-S Risperdal Consta 50mg prášok a disperzné prostredie na intramuskulárnu injekčnú sus00242/0377 Risperdal Consta 50mgNL/H/0156/008 Slovak Republic 68/0230/07-S Seroquel XR 50mg tablety s predĺženým uvoľňovaním 50827/0006 Seroquel XL 50mg tabsNL/H/0156/009 Slovak Republic 68/0231/07-S Seroquel XR 200mg tablety s predĺženým uvoľňovaním 50827/0008 Seroquel XL 200mg tabsNL/H/0156/010 Slovak Republic 68/0232/07-S Seroquel XR 300mg tablety s predĺženým uvoľňovaním 50827/0009 Seroquel XL 300mg tabsSE/H/1821/001 Slovak Republic 69/0204/02-S Nasonex 50 mikrogramov/dávka, nosová suspenzná aerodisperzia 00025/0587 Nasonex 50ug/actuation nasal sprayNL/H/0487/001 Slovak Republic 73/0063/05-S Vesicare 5mg potahovane tablety 00166/0197 Vesicare 5mg tabsNL/H/0487/002 Slovak Republic 73/0064/05-S Vesicare 10mg potahovane tablety 00166/0198 Vesicare 10mg tabsDE/H/2251/001 Slovak Republic 77/0268/10-S Duodart 0,5mg/0,4mg tvrdé kapsuly 19494/0046 Combodart 0.5mg/0.4mg capsSE/H/0304/001 Slovak Republic 87/0286/04-S Avodart 0.5mg make kapsuly 19494/0006 Avodart 0.5mg soft capsNL/H/0150/001 Slovenia 5363-I-281/14 Nexplanon 68 mg implantat 00025/0563 NexplanonDK/H/0279/001 Slovenia H/02/00436/001-005 Daivobet 50 mikrogramov/500 mikrogramov v 1 g mazilo 05293/0003 Dovobet ointmentFR/H/0110/001 Slovenia H/03/00606/001 Femara 2,5 mg filmsko oblozene tablete 00101/0493 Femara 2.5mg tabsDE/H/4019/005 Spain 56799 Sandimmun Neoral 100mg/ml solucion oral 00101/0390 Neoral 100mg/ml solutionDE/H/5314/001 Spain 57233 Dumirox 50mg comprimidos recubiertos 46302/0034 Faverin 50mg tabsSE/H/0404/002 Spain 57768 Renitec 5mg comprimidos 00025/0194 Innovace 5mg tabsFR/H/0416/002 Spain 57973 Baycip 500mg comprimidos recubiertos con pelicula 00010/0147 Ciproxin 500mg tabsDE/H/5314/002 Spain 58212 Dumirox 100mg comprimidos recubiertos 46302/0033 Faverin 100mg tabsNL/H/2081/002 Spain 58377 Losec 20mg capsulas duras gastrorresistentes 17901/0133 Losec 20mg capsDE/H/0769/002 Spain 58511 Ecazide 50mg/25mg comprimidos 00034/0263 Capozide tabsDE/H/3456/001 Spain 58765 Diflucan 50mg capsulas duras 00057/0289 Diflucan 50mg capsDE/H/3456/003 Spain 58766 Diflucan 150mg capsulas duras 00057/0290 Diflucan 150mg capsNL/H/0577/001 Spain 58832 Lopid 600mg 00057/0535 Lopid 600mg tabsFI/H/0995/002 Spain 58845 Zocor 10mg comprimidos recubiertos con pelicula 00025/0241 Zocor 10mg tabsFI/H/0995/003 Spain 58846 Zocor 20mg comprimidos recubiertos con pelicula 00025/0242 Zocor 20mg tabsSE/H/0527/004 Spain 59127 Zestril 20mg comprimidos 17901/0063 Zestril 20mg tabsDE/H/3456/005 Spain 59672 Diflucan 10mg/ml polvo para suspension oral 00057/0343 Diflucan 10mg/ml oral suspensionDE/H/3456/005 Spain 59672 Diflucan 10mg/ml polvo para suspension oral 00057/0343 Diflucan 10mg/ml oral suspensionDE/H/3456/008 Spain 59673 Diflucan 200mg/5ml polvo para suspension oral 00057/0344 Diflucan 40mg/ml oral suspensionNL/H/1732/002 Spain 59717 Besitran 50mg comprimidos recubiertos con pelicula 00057/0308 Lustral 50mg tabsNL/H/1732/003 Spain 59718 Besitran 100mg comprimidos recubiertos con pelicula 00057/0309 Lustral 100mg tabsDE/H/4019/003 Spain 60318 Sandimmun Neoral 50mg capsulas blandas 00101/0388 Neoral 50mg soft capsDE/H/4019/002 Spain 60319 Sandimmun Neoral 25mg capsulas blandas 00101/0387 Neoral 25mg soft capsDE/H/4019/004 Spain 60320 Sandimmun Neoral 100mg capsulas blandas 00101/0389 Neoral 100mg soft capsDE/H/2184/003 Spain 60336 Risperdal 1mg comprimidos recubiertos con película 00242/0186 Risperdal 1mg tabsDE/H/0899/002 Spain 60621 Neurontin 300mg 50622/0047 Neurontin 300mg capsDK/H/2848/001 Spain 60634 Iopimax 5mg/ml colirio en solucion 00101/0996 Iopidine 5mg/ml eye dropsFR/H/0070/001 Spain 60651 Trusopt 20mg/ml colirio en solucion 16058/0014 Trusopt Eye DropsNL/H/1457/002 Spain 60913 Cozaar 50mg comprimidos recubiertos con pelicula 00025/0324 Cozaar 50mg tabs

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductIE/H/0165/003 Spain 61005 Prograf 5mg capsulas duras 00166/0204 Prograf 5mg hard capsIE/H/0165/002 Spain 61006 Prograf 1mg capsulas duras 00166/0203 Prograf 1mg hard capsAT/H/0904/001 Spain 61286 Arimidex 1mg comprimidos recubiertos con pelicula 17901/0002 Arimidex 1mg tabsFI/H/0995/004 Spain 61497 Zocor Forte 40mg comprimidos 00025/0243 Zocor 40mg tabsDE/H/3259/001 Spain 61540 Modiodal 100mg comprimidos 14776/0098 Provigil 100mg tabsNL/H/1539/002 Spain 61561 Lamictal 5mg comprimidos dispersables/masticables 00003/0346 Lamictal 5mg dispersible tabsNL/H/1539/004 Spain 61562 Lamictal 50mg comprimidos dispersables/masticables 00003/0368 Lamictal 50mg dispersible tabsNL/H/1539/005 Spain 61568 Lamictal 100mg comprimidos dispersables/masticables 00003/0348 Lamictal 100mg dispersible tabsNL/H/1539/003 Spain 61569 Lamictal 25mg comprimidos dispersables/masticables 00003/0347 Lamictal 25mg dispersible tabsNL/H/1458/001 Spain 61600 Cozaar Plus 50mg/12.5mg comprimidos recubiertos con pelicula 00025/0338 Cozaar Comp 50mg/12.5mgNL/H/0115/001 Spain 61629 Imigran 10mg solución para pulverización nasal 10949/0260 Imigran 10mg Nasal SprayNL/H/4790/001 Spain 61653 Zanidip 10mg comprimidos recubiertos con pelicula 04595/0005 Zanidip 10mg tabsDE/H/0109/001 Spain 61654 Zarator 10mg comprimidos recubiertos con pelicula 50622/0036 Lipitor 10mg tabsDE/H/0109/002 Spain 61655 Zarator 20mg comprimidos recubiertos con pelicula 50622/0039 Lipitor 20mg tabsDE/H/0109/003 Spain 61656 Zarator 40mg comprimidos recubiertos con pelicula 50622/0041 Lipitor 40mg tabsSE/H/0121/001 Spain 61666 Oxis Turbuhaler 4,5mcg/inhalacion polvo para inhalacion 17901/0154 Oxis Turbohaler 6SE/H/0121/002 Spain 61667 Oxis Turbuhaler 9mcg/inhalacion polvo para inhalacion 17901/0153 Oxis Turbohaler 12DE/H/6157/001 Spain 61756 Xalatan 0,005 % colirio en solución 00057/1057 Xalatan eye dropsSE/H/0110/001 Spain 61873 Topamax 25mg comprimidos recubiertos 00242/0301 Topamax 25mg tabsSE/H/0110/002 Spain 61874 Topamax 50mg comprimidos recubiertos 00242/0302 Topamax 50mg tabsSE/H/0110/003 Spain 61875 Topamax 100mg comprimidos recubiertos 00242/0303 Topamax 100mg tabsSE/H/0110/004 Spain 61876 Topamax 200mg comprimidos recubiertos con pelicula 00242/0304 Topamax 200mg tabsSE/H/1821/001 Spain 61905 Nasonex 50 microgramos suspensión para pulverización nasal 00025/0587 Nasonex 50ug/actuation nasal sprayIE/H/0805/002 Spain 61910 Telfast 120mg Comprimidos 04425/0157 Telfast 120mg tabsIE/H/0805/003 Spain 61911 Fexofenadaina Sanofi 180 mg comprimidos recubiertos con pelicula 04425/0158 Telfast 180mg tabsNL/H/3915/002 Spain 61959 Durogesic Matrix 25 microgramos/hora parches transdérmicos 00242/0192 Durogesic DTrans 25ug/hrNL/H/3915/003 Spain 61960 Durogesic Matrix 50 microgramos/hora parches transdérmicos 00242/0193 Durogesic DTrans 50ug/hrNL/H/3915/005 Spain 61961 Durogesic Matrix 100 microgramos/hora parches transdérmicos 00242/0195 Durogesic DTrans 100ug/hrPT/H/2256/001 Spain 61970 Nasacort 55mcg 04425/0287 Nasacort 55mcg/dose nasal sprayFI/H/0102/002 Spain 61983 Oculotect 50mg/ml colirio en solucion en envase unidosis 00101/0611 Oculotect 50mg/ml eye drops SDUDK/H/3015/001 Spain 62010 Alphagan 0.2% Eye Drops 00426/0088 Alphagan 2mg/ml eye dropsDE/H/2184/008 Spain 62096 Risperdal 1mg/ml solucion oral 00242/0199 Risperdal 1mg/ml oral solnDE/H/5587/001 Spain 62110 Tradonal retard 50mg capsulas duras de liberacion prolongada 46302/0149 Zamadol SR 50mg capsDE/H/5587/002 Spain 62111 Tradonal retard 100mg capsulas duras de liberacion prolongada 46302/0150 Zamadol SR 100mg capsDE/H/5587/003 Spain 62112 Tradonal retard 150mg capsulas duras de liberacion prolongada 46302/0151 Zamadol SR 150mg capsDE/H/5587/004 Spain 62113 Tradonal retard 200mg capsulas duras de liberacion prolongada 46302/0152 Zamadol SR 200mg capsNL/H/1457/001 Spain 62117 Cozaar 12.5mg Inicio comprimidos recubiertos con pelicula 00025/0515 Cozaar 12.5mg tabsSE/H/0565/001 Spain 62206 Co-Diovan 80mg/12.5mg comprimidos recubiertos con pelicula 00101/0480 Co-Diovan 80/12.5mg tabsSE/H/0147/001 Spain 62285 Cerazet 75 microgramos comprimidos 00025/0562 Cerazette 75mcg tabsNL/H/0144/004 Spain 62291 Maxalt Max 10mg Liofilizado Oral 00025/0372 Maxalt Melt 10mgSE/H/0139/002 Spain 62534 Urotrol 2mg, comprimidos recubiertos con pelicula 50622/0016 Detrusitol 2mg tabsDK/H/0134/001 Spain 62535 Cosopt 20mg/ml+5mg/ml Colirio en solucion 16058/0016 Cosopt solutionNL/H/0150/001 Spain 62628 Implanon NXT 68mg Implante 00025/0563 NexplanonSE/H/0169/001 Spain 62667 Seretide Accuhaler 50mcg/100mcg/inhalacion 10949/0314 Seretide 100 AccuhalerSE/H/0169/002 Spain 62668 Seretide Accuhaler 50mcg/250mcg/inhalacion 10949/0315 Seretide 250 AccuhalerSE/H/0169/003 Spain 62669 Seretide Accuhaler 50mcg/500mcg/inhalacion 10949/0316 Seretide 500 AccuhalerDE/H/4690/002 Spain 62760 Triapin 5mg/5mg comprimidos de libeeracion prolongada 04425/0320 Triapin 5mg/5mg PR tabsDE/H/5916/001 Spain 62797 Isotrex Eritromicina Gel 19494/0068 Isotrexin Gel

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductDE/H/2184/007 Spain 62803 Risperdal 6mg comprimidos recubiertos con pelicula 00242/0317 Risperdal 6mg tabsAT/H/0754/002 Spain 63000 Clexane 150mg (15000IU) solucion 04425/0185 Clexane Forte 15000IU (150mg)/1mlAT/H/0754/001 Spain 63002 Clexane 120mg (12000IU) solucion 04425/0185 Clexane Forte 12000IU (120mg)/0.8mlNL/H/4752/001 Spain 63029 Aromasil 25mg comprimidos recubiertos 00057/0930 Aromasin 25mg tabsNL/H/0156/001 Spain 63054 Seroquel 25mg comprimidos recubiertos con pelicula 50827/0002 Seroquel 25mg tabsNL/H/0156/002 Spain 63055 Seroquel 100mg comprimidos recubiertos con pelicula 50827/0003 Seroquel 100mg tabsNL/H/0156/003 Spain 63056 Seroquel 200mg comprimidos recubiertos con pelicula 50827/0004 Seroquel 200mg tabsDK/H/0168/002 Spain 63093 Trileptal 300mg comprimidos recubiertos con pelicula 00101/0582 Trileptal 300mg tabsDK/H/0168/003 Spain 63095 Trileptal 600mg comprimidos recubiertos con pelicula 00101/0583 Trileptal 600mg tabsDE/H/0899/005 Spain 63149 Neurontin 800mg 50622/0050 Neurontin 800mg tabsDE/H/0899/004 Spain 63150 Neurontin 600mg 50622/0049 Neurontin 600mg tabsIE/H/0165/001 Spain 63189 Prograf 0.5mg capsulas duras 00166/0206 Prograf 0.5mg hard capsSE/H/0210/004 Spain 63388 Reminyl 4mg/ml solucion oral 08557/0042 Reminyl 4mg/ml solnDE/H/6220/001 Spain 63452 Malarone 250 mg/100 mg comprimidos recubiertos con película 10949/0258 Malarone tabsNL/H/1458/003 Spain 63476 Fortzaar 100mg/25mg comprimidos recubiertos con pelicula 00025/0374 Cozaar Comp 100mg/25mgDE/H/0235/001 Spain 63533 Secalipsupra 160mg comprimidos recubiertos con pelicula 46302/0024 Supralip 160mg tabsSE/H/0225/001 Spain 63619 Zaditen 0,25 mg/ml colirio en solución 20162/0019 Zaditen 0.25mg/ml eye dropsFR/H/0171/001 Spain 63644 Diamicron 30mg 05815/0019 Diamicron 30mg MR tabsFI/H/0104/003 Spain 63673 Singulair 4mg comprimidos masticables 00025/0412 Singulair Paediatric 4mg tabsSE/H/1843/001 Spain 63692 Zidoval 7,5mg/g Gel Vaginal 46302/0153 Zidoval 7.5mg/g Vaginal gelDE/H/5770/002 Spain 63797 Seretide 25microgramos/125microgamos suspension para inhalacion en envase a pres10949/0338 Seretide 125 EvohalerDE/H/5770/003 Spain 63798 Seretide 25microgramos/250microgramos, suspension para inhalacion en envase a pre10949/0339 Seretide 250 EvohalerIE/H/0658/001 Spain 63893 Apo-Go Pen 10mg/ml Solucion Inyectable 04483/0073 Apo-Go Pen 10mg/mlAT/H/0870/001 Spain 63955 FOSAMAX Semanal 70 mg comprimidos 00025/0399 Fosamax Once Weekly 70mg tabsSE/H/0230/001 Spain 63956 Symbicort Turbuhaler 80mcg/4.5mcg/inhalacion 17901/0091 Symbicort 100/6 TurbohalerSE/H/0110/007 Spain 63957 Topamax 15mg disperable capsulas 00242/0348 Topamax Sprinkle 15mg capsSE/H/0229/001 Spain 63958 Symbicort Turbuhaler 160 microgramos/4.5 microgramos/inhalacion 17901/0092 Symbicort 200/6 TurbohalerSE/H/0110/008 Spain 63959 Topamax 25mg disperable capsulas 00242/0349 Topamax Sprinkle 25mg capsSE/H/0110/009 Spain 63960 Topamax 50mg disperable capsulas 00242/0350 Topamax Sprinkle 50mg capsDE/H/6124/001 Spain 64056 Actiq 200 microgramos, comprimidos para chupar con aplicador bucal integrado 14776/0092 Actiq 200mcg lozengeSE/H/0249/001 Spain 64187 Xalacom 50 microgramos/ml + 5 mg/ml colirio en solucion 00057/1056 Xalacom eye dropsSE/H/0139/004 Spain 64245 Detrusitol Neo 4mg Capsulas Duras de liberacion Prolongada 50622/0017 Detrusitol XL 4mg capsDE/H/0299/001 Spain 64287 Xazal 5mg comprimidos recubiertos con película 00039/0539 Xyzal 5mg tabsDK/H/0168/004 Spain 64398 Trileptal 60mg/ml suspension 00101/0631 Trileptal 60mg/ml suspensionNL/H/0156/007 Spain 64436 Seroquel 300mg comprimidos recubiertos con pelicula 50827/0005 Seroquel 300mg tabsSE/H/0406/003 Spain 64454 Diován 80mg comprimidos recubiertos con película 00101/0600 Diovan 80mg tabsSE/H/0406/004 Spain 64473 Diován 160mg comprimidos recubiertos con película 00101/0601 Diovan 160mg tabsDE/H/0109/004 Spain 64529 Zarator 80mg comprimidos recubiertos con pelicula 50622/0043 Lipitor 80mg tabsDK/H/0279/001 Spain 64543 Daivobet 50 microgramos/0.5mg/g pomada 05293/0003 Dovobet ointmentDE/H/0307/001 Spain 64684 Transtec 35 microgramos/hora parche transdérmico 04539/0014 Transtec 35ug/hr patchDE/H/0307/002 Spain 64685 Transtec 52.5 microgramos/hora parche transdérmico 04539/0015 Transtec 52.5ug/hr patchDE/H/0307/003 Spain 64686 Transtec 70 microgramos/hora parche transdérmico 04539/0016 Transtec 70ug/hr patchNL/H/0299/001 Spain 64796 Spiriva 18mcg polvo para inhalacion 14598/0062 Spiriva 18mcg inhalation powderPT/H/2299/001 Spain 64928 Arcoxia 60mg comprimidos recubuertos con pelicular 00025/0642 Arcoxia 60mg tabsPT/H/2299/002 Spain 64929 Arcoxia 90mg comprimidos recubuertos con pelicular 00025/0643 Arcoxia 90mg tabsPT/H/2299/003 Spain 64930 Arcoxia 120mg comprimidos recubuertos con pelicular 00025/0644 Arcoxia 120mg tabsNL/H/1457/003 Spain 64971 Cozaar 100mg comprimidos recubiertos con pelicula 00025/0416 Cozaar 100mg tabsNL/H/3915/004 Spain 65032 Durogesic Matrix 75 microgramos/hora parches transdérmicos 00242/0194 Durogesic DTrans 75ug/hr

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductSE/H/0229/002 Spain 65044 Symbicort Turbuhaler 320 microgramos/9 microgramos/inhalacion 17901/0200 Symbicort 400/12 TurbohalerDE/H/6007/001 Spain 65148 Concerta 18mg comprimidos de liberacion prolongada 00242/0372 Concerta XL 18mg tabsDE/H/6007/002 Spain 65170 Concerta 36mg comprimidos de liberacion prolongada 00242/0373 Concerta XL 36mg tabsSE/H/0304/001 Spain 65178 Avidart 0.5mg capsulas blandas 19494/0006 Avodart 0.5mg soft capsNL/H/4790/002 Spain 65379 Zanidip 20mg comprimidos recubiertos con pelicula 04595/0010 Zanidip 20mg tabsFR/H/0105/001 Spain 65476 Omacor capsula blanda 15905/0001 Omacor 1000mg soft capsDE/H/0384/001 Spain 65492 Olmetec 10mg comprimidos recubiertos 08265/0015 Olmetec 10mg tabsDE/H/0384/002 Spain 65496 Olmetec 20mg comprimidos recubiertos 08265/0016 Olmetec 20mg tabsDE/H/0384/003 Spain 65497 Olmetec 40mg comprimidos recubiertos 08265/0017 Olmetec 40mg tabsDE/H/2184/016 Spain 65696 Risperdal Flas 0,5mg Comprimidos Bucodispersables 00242/0378 Risperdal Quicklet 0.5mg tabsDE/H/2184/009 Spain 65697 Risperdal Flas 1mg Comprimidos Bucodispersables 00242/0379 Risperdal Quicklet 1mg tabsDE/H/2184/010 Spain 65698 Risperdal Flas 2mg Comprimidos Bucodispersables 00242/0380 Risperdal Quicklet 2mg tabsSE/H/0565/002 Spain 65794 Co-Diovan 160mg/12.5mg comprimidos recubiertos con pelicula 00101/0650 Co-Diovan 160/12.5mg tabsDK/H/2933/001 Spain 65849 Intestifalk 3 mg cápsulas gastrorresistentes 08637/0002 Budenofalk 3mg capsFI/H/0313/001 Spain 66470 Reandron 1000mg/4ml solución inyectable 00010/0549 Nebido 1000mg/4ml injDE/H/0496/002 Spain 66513 Inegy 10mg/20mg comprimidos 00025/0610 Inegy 10mg/20mg tabsDE/H/0496/003 Spain 66514 Inegy 10mg/40mg comprimidos 00025/0611 Inegy 10mg/40mg tabsSE/H/0565/003 Spain 66526 Co-Diovan Forte 160mg/25mg comprimidos recubiertos con pelicula 00101/0651 Co-Diovan 160/25mg tabsSE/H/0210/005 Spain 66650 Reminyl 8mg capsulas duras de liberacion prolongada 08557/0052 Reminyl XL 8mg capsSE/H/0210/006 Spain 66651 Reminyl 16mg capsulas duras de liberacion prolongada 08557/0053 Reminyl XL 16mg capsSE/H/0210/007 Spain 66652 Reminyl 24mg capsulas duras de liberacion prolongada 08557/0054 Reminyl XL 24mg capsSE/H/0406/005 Spain 66910 Diován Cardio 40mg comprimidos recubiertos con película 00101/0599 Diovan 40mg tabsDK/H/0703/003 Spain 66942 Budesonida Aldo-Union 0.5mg/ml suspension para inhalaction por nubulizador 00142/1108 Budesonide 1mg nebuliser solnDK/H/0703/002 Spain 66943 Budesonida Aldo-Union 0.25mg/ml suspension para inhalaction por nubulizador 00142/1107 Budesonide 0.5mg nebuliser solnNL/H/3915/001 Spain 67029 Durogesic Matrix 12 microgramos/hora parches transdérmicos 00242/0409 Durogesic DTrans 12ug/hrDE/H/0528/001 Spain 67037 Broncoral Neo 08829/0154 Atimos ModuliteDE/H/2184/012 Spain 67051 Risperdal Flas 4mg Comprimidos Bucodispersables 00242/0408 Risperdal Quicklet 4mg tabsDE/H/2184/011 Spain 67052 Risperdal Flas 3mg Comprimidos Bucodispersables 00242/0407 Risperdal Quicklet 3mg tabsCZ/H/0939/001 Spain 67515 Postinor 1500microgramos Comprimido 04854/0150 Levonelle 1500mcg tabsFR/H/0272/001 Spain 67585 Dolpar 100 mg comprimidos de liberación prolongada 43808/0001 Tradorec XL 100mg tabsFR/H/0272/002 Spain 67586 Dolpar 200mg comprimidos de liberación prolongada 43808/0002 Tradorec XL 200mg tabsFR/H/0272/003 Spain 67587 Dolpar 300mg comprimidos de liberación prolongada 43808/0003 Tradorec XL 300mg tabs

ES/H/0575/006 Spain 67656 Strattera 60mg Capsulas Duras 00006/0379 Strattera 60mg capsES/H/0575/005 Spain 67657 Strattera 40mg Capsulas Duras 00006/0378 Strattera 40mg capsES/H/0575/003 Spain 67659 Strattera 18mg Capsulas Duras 00006/0376 Strattera 18mg capsES/H/0575/002 Spain 67660 Strattera 10mg Capsulas Duras 00006/0375 Strattera 10mg capsES/H/0575/004 Spain 67661 Strattera 25mg Capsulas Duras 00006/0377 Strattera 25mg capsDE/H/0523/001 Spain 67672 Olmetec Plus 20mg /12,5mg comprimidos recubiertos con película 08265/0022 Olmetec Plus 20mg/12.5mg tabsDE/H/0523/002 Spain 67679 Olmetec Plus 20mg /25mg comprimidos recubiertos con película 08265/0023 Olmetec Plus 20mg/25mg tabsFR/H/0258/001 Spain 67919 Adartrel 0.25mg comprimidos recubiertos con pelicula 19494/0033 Adartrel 0.25mg tabsFR/H/0258/002 Spain 67921 Adartrel 0.5mg comprimidos recubiertos con pelicula 19494/0034 Adartrel 0.5mg tabsFR/H/0258/004 Spain 67922 Adartrel 2mg comprimidos recubiertos con pelicula 19494/0036 Adartrel 2mg tabsSE/H/1985/001 Spain 68316 Clobex 500 microgramos/g champu 10590/0052 Etrivex 500 micrograms/g shampooSE/H/0571/001 Spain 68348 Itnogen 2% gel 16508/0025 Tostran 2% gelDE/H/0690/004 Spain 68542 Medikinet 10 mg cápsulas duras de liberación modificada 11243/0005 Medikinet XL 10mg capsDE/H/0690/005 Spain 68543 Medikinet 20 mg cápsulas duras de liberación modificada 11243/0006 Medikinet XL 20mg capsDE/H/0690/006 Spain 68544 Medikinet 30 mg cápsulas duras de liberación modificada 11243/0007 Medikinet XL 30mg capsDE/H/0690/007 Spain 68545 Medikinet 40 mg cápsulas duras de liberación modificada 11243/0008 Medikinet XL 40mg caps

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductDE/H/0871/001 Spain 68802 Foster 100/6 microgramos/pulsación Solución para inhalación en envase a presión 08829/0156 Fostair 100/6 inhalerSE/H/0406/006 Spain 68817 Diován 320mg comprimidos recubiertos con película 00101/0726 Diovan 320mg tabsPT/H/2299/004 Spain 69376 Arcoxia 30mg comprimidos recubiertos con pelicula 00025/0641 Arcoxia 30mg tabsDE/H/6121/001 Spain 69562 Pletal 100mg comprimidos 11515/0001 Pletal 100mg tabsDE/H/6121/002 Spain 69563 Pletal 50mg comprimidos 11515/0002 Pletal 50mg tabsNL/H/0718/001 Spain 69589 Spiriva Respimat 2.5 microgramos, solucion for inhalacion 14598/0084 Spiriva RespimatNL/H/0156/008 Spain 69645 Seroquel prolong 50mg comprimidos de liberacion prolongada 50827/0006 Seroquel XL 50mg tabsNL/H/0156/009 Spain 69646 Seroquel prolong 200mg comprimidos de liberacion prolongada 50827/0008 Seroquel XL 200mg tabsNL/H/0156/010 Spain 69647 Seroquel prolong 300mg comprimidos de liberacion prolongada 50827/0009 Seroquel XL 300mg tabsNL/H/0156/011 Spain 69648 Seroquel prolong 400mg comprimidos de liberacion prolongada 50827/0010 Seroquel XL 400mg tabsDE/H/6007/004 Spain 69988 Concerta 27mg comprimidos de liberacion prolongada 00242/0400 Concerta XL 27mg tabsNL/H/1113/001 Spain 70079 Sevikar 20mg/5mg comprimidos recubiertos con pelicula 08265/0026 Sevikar 20mg/5mg tabsES/H/0575/008 Spain 70123 Strattera 100mg Capsulas Duras 00006/0616 Strattera 100mg capsES/H/0575/007 Spain 70124 Strattera 80mg Capsulas Duras 00006/0615 Strattera 80mg capsNL/H/0732/001 Spain 70144 Mezavant 1200mg, comprimidos de liberación prolongada gastrorresistentes 08081/0040 Mezavant XL 1200mg tabsDK/H/0279/002 Spain 70191 Daivobet 50 microgramos/0,5mg/g gel 05293/0005 Dovobet gelNL/H/0343/001 Spain 70243 Crestor 10mg comprimidos recubiertos con pelicula 17901/0201 Crestor 10mg tabsNL/H/0343/002 Spain 70244 Crestor 20mg comprimidos recubiertos con pelicula 17901/0202 Crestor 20mg tabsNL/H/0343/004 Spain 70334 Crestor 5mg comprimidos recubiertos con pelicula 17901/0243 Crestor 5mg tabsNL/H/0156/012 Spain 70859 Seroquel prolong 150mg comprimidos de liberacion prolongada 50827/0007 Seroquel XL 150mg tabsDE/H/1612/001 Spain 71124 Targin 10mg/5mg comprimidos de liberacion prolongada 16950/0157 Targinact 10mg/5mg tabsDE/H/1612/002 Spain 71125 Targin 20mg/10mg comprimidos de liberacion prolongada 16950/0158 Targinact 20mg/10mg tabsDE/H/1612/003 Spain 71126 Targin 40mg/20mg comprimidos de liberacion prolongada 16950/0161 Targinact 40mg/20mg tabsDE/H/1612/004 Spain 71127 Targin 5mg/2.5mg comprimidos de liberacion prolongada 16950/0162 Targinact 5mg/2.5mg tabsNL/H/4734/001 Spain 71283 Insucor 2.5mg comprimidos 25258/0002 Nebivolol 2.5mg tabsNL/H/1340/001 Spain 71673 Adoport 0.5mg capsulas duras EFG 04416/0939 Adoport 0.5mg capsNL/H/1340/002 Spain 71674 Adoport 1mg capsulas duras EFG 04416/0940 Adoport 1mg capsNL/H/1340/003 Spain 71675 Adoport 5mg capsulas duras EFG 04416/0941 Adoport 5mg capsDE/H/1913/001 Spain 71696 Lercanidipino Tevagen 10mg comprimidos recubiertos con pelicula EFG 00289/1283 Lercanidipine hydrochloride 10mg tabsDE/H/1913/002 Spain 71697 Lercanidipino Tevagen 20mg comprimidos recubiertos con pelicula EFG 00289/1284 Lercanidipine hydrochloride 20mg tabsDE/H/5733/001 Spain 71848 Versatis 700mg apósito adhesivo medicamentoso 21727/0016 Versatis 700mg medicated plasterNL/H/1375/001 Spain 72020 Sumatriptan Sun 6mg/0.5ml solucion inyectable efg 31750/0012 Sumatriptan Sun 6mg/0.5ml injectionDE/H/0363/006 Spain 72040 Salofalk 500 mg comprimidos gastrorresistentes 08637/0019 Salofalk 500mg tabsDE/H/2251/001 Spain 72275 Duodart 0.5/0.4mg capsulas duras 19494/0046 Combodart 0.5mg/0.4mg capsDK/H/2871/001 Spain 72279 Picoprep 03194/0014 PicolaxDE/H/0523/003 Spain 72695 Olmetec Plus 40mg /12,5mg comprimidos recubiertos con película 08265/0029 Olmetec Plus 40mg/12.5mg tabsDE/H/0523/004 Spain 72697 Olmetec Plus 40mg /25mg comprimidos recubiertos con película 08265/0030 Olmetec Plus 40mg/25mg tabsBE/H/0150/001 Spain 73005 Setofilm 4mg Peliculas Bucodispersables EFG 21042/0011 Setofilm 4mg Orodispersible filmsBE/H/0150/002 Spain 73006 Setofilm 8mg Peliculas Bucodispersables EFG 20412/0012 Setofilm 8mg Orodispersible filmsSE/H/0908/001 Spain 73186 Jext 150 microgramos solucion inyectable en pluma precargada 10085/0052 Jext 150mcg PenSE/H/0908/002 Spain 73187 Jext 300 microgramos solucion inyectable en pluma precargada 10085/0053 Jext 300mcg PenIE/H/0213/001 Spain 73232 Soludronate Semanal 70 mg solucion oral 34111/0001 Alendronic Acid 70mg oral solnDE/H/2020/004 Spain 73243 Palexia retard 50mg comprimidos de liberación prolongada 21727/0041 Palexia SR 50mg tabsDE/H/2020/005 Spain 73244 Palexia retard 100mg comprimidos de liberación prolongada 21727/0042 Palexia SR 100mg tabsDE/H/2020/006 Spain 73245 Palexia retard 150mg comprimidos de liberación prolongada 21727/0043 Palexia SR 150mg tabsDE/H/2020/007 Spain 73246 Palexia retard 200mg comprimidos de liberación prolongada 21727/0044 Palexia SR 200mg tabsDE/H/2020/008 Spain 73247 Palexia retard 250mg comprimidos de liberación prolongada 21727/0045 Palexia SR 250mg tabsDE/H/0690/008 Spain 73308 Medikinet 5 mg cápsulas duras de liberación modificada 11243/0010 Medikinet XL 5mg caps

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductDK/H/0134/002 Spain 73508 Cosopt PF 20mg/ml + 5mg/ml colirio en solucion en envase unidosis 16058/0015 Cosopt SDUES/H/0189/002 Spain 73584 Lormetazepam KERN PHARMA 1mg comprimidos EFG 17780/0609 Lormetazepam 1mg tabsDE/H/5854/001 Spain 73714 Solaraze 30mg/g gel 16973/0012 Solaraze 3% gelNL/H/1151/001 Spain 73938 Naltrexona Accord 50 mg comprimidos recubiertos con pelicula 20075/0144 Naltrexone hydrochloride Accord 50mg tabsDE/H/5683/001 Spain 75467 Intestifalk Uno 9mg granulado gastroresistente 08637/0020 Budenofalk 9mg granulesDK/H/2028/001 Spain 75518 Metilfenidato Sandoz 18mg comprimidos de liberación prolongada EFG 04416/1346 Matoride XL 18mg tabsDK/H/2028/002 Spain 75519 Metilfenidato Sandoz 36mg comprimidos de liberación prolongada EFG 04416/1348 Matoride XL 36mg tabsDK/H/2028/003 Spain 75520 Metilfenidato Sandoz 54mg comprimidos de liberación prolongada EFG 04416/1349 Matoride XL 54mg tabsDE/H/2020/009 Spain 75917 Palexia retard 25mg comprimidos de liberación prolongada 21727/0051 Palexia SR 25mg tabsDE/H/5609/001 Spain 76048 Binosto 70mg comprimidos efervescentes 40861/0006 Binosto 70mg effervescent tabsDK/H/2888/003 Spain 76060 Equasym 30mg capsulas duras de liberaction modificada 27303/0006 Equasym XL 30mg capsDK/H/2888/001 Spain 76061 Equasym 10mg capsulas duras de liberaction modificada 27303/0004 Equasym XL 10mg capsDK/H/2888/002 Spain 76076 Equasym 20mg capsulas duras de liberaction modificada 27303/0005 Equasym XL 20mg capsDE/H/3355/001 Spain 76618 Dymista 137 microgramos/50 microgramos/ aplicación, suspensión para pulverización 15142/0258 Dymista Nasal SprayDE/H/0871/002 Spain 76713 Foster Nexthaler 100 microgramos/6 microgramos / inhalación polvo para inhalación 08829/0173 Fostair Nexthaler 100/6DK/H/2888/004 Spain 77163 Equasym 40mg capsulas duras de liberaction modificada 27303/0007 Equasym XL 40mg capsDK/H/2888/005 Spain 77164 Equasym 50mg capsulas duras de liberaction modificada 27303/0008 Equasym XL 50mg capsNL/H/2564/001 Spain 77174 Propranolol Accord 10mg comprimidos recubiertos con pelicula 20075/0360 Propranolol 10mg tabsNL/H/2564/002 Spain 77175 Propranolol Accord 40mg comprimidos recubiertos con pelicula 20075/0361 Propranolol 40mg tabsSE/H/1839/003 Spain 77644 Elvanse 70mg capsulas duras 08081/0052 Elvanse 70mg capsFR/H/0689/001 Spain 77867 Estring 7.5 microgramos cada 24 horas sistema de liberacion vaginal 00057/1424 Estring 7.5mcg/24hrsDE/H/0690/010 Spain 78454 Medikinet 60 mg cápsulas duras de liberación modificada 11243/0012 Medikinet XL 60mg capsSE/H/1921/002 Spain 78536 Flutiform 125 microgramos/5 microgramos/inhalación, suspensión para inhalación en e16950/0168 Flutiform 125mcg/5mcg inhalerSE/H/1921/003 Spain 78537 Flutiform 250 microgramos/10 microgramos/inhalación, suspensión para inhalación en 16950/0169 Flutiform 250mcg/10mcg inhalerSE/H/1921/001 Spain 78538 Flutiform 50 microgramos/5 microgramos/inhalación, suspensión para inhalación en en16950/0167 Flutiform 50mcg/5mcg inhalerSE/H/0643/005 Spain 78634 Metoject Pen 15mg solucion inyectable en pluma precargada 11587/0079 Metoject Pen 15mgSE/H/1969/001 Spain 78677 Abriff 50 microgramos/5 microgramos/inhalación 16950/0188 Abriff 50/5 inhalerSE/H/1969/003 Spain 78678 Abriff 250 microgramos/10 microgramos/inhalación 16950/0190 Abriff 250/10 inhalerSE/H/1969/002 Spain 78679 Abriff 125 microgramos/5 microgramos/inhalación 16950/0189 Abriff 125/5 inhalerHU/H/0399/001 Spain 81414 Dexametasona Krka 4 mg comprimidos 01656/0205 Dexamethasone 4mg tabsDK/H/0134/003 Spain 83389 Cosopt PF 20mg/ml + 5mg/ml colirio en solución 16058/0025 Cosopt iMultiNL/H/1540/001 Sweden 12008 Lamictal 25mg tablets 00003/0272 Lamictal 25mg tabsNL/H/1540/002 Sweden 12009 Lamictal 50mg tablets 00003/0273 Lamictal 50mg tabsNL/H/1540/003 Sweden 12010 Lamictal 100mg tablets 00003/0274 Lamictal 100mg tabsNL/H/1540/004 Sweden 12011 Lamictal 200mg tablets 00003/0297 Lamictal 200mg tabsNL/H/1457/002 Sweden 12209 Cozaar 50mg filmdragerad tablett 00025/0324 Cozaar 50mg tabsDE/H/4019/002 Sweden 12308 Sandimmun Neoral 25mg mjuka kapslar 00101/0387 Neoral 25mg soft capsDE/H/4019/003 Sweden 12309 Sandimmun Neoral 50mg mjuka kapslar 00101/0388 Neoral 50mg soft capsDE/H/4019/004 Sweden 12310 Sandimmun Neoral 100mg mjuka kapslar 00101/0389 Neoral 100mg soft capsDE/H/4019/005 Sweden 12311 Sandimmun Neoral 100mg/ml oral lösning 00101/0390 Neoral 100mg/ml solutionNL/H/3915/002 Sweden 12483 Durogesic 25 mikrogram/timme depotplåster 00242/0192 Durogesic DTrans 25ug/hrNL/H/3915/003 Sweden 12484 Durogesic 50 mikrogram/timme depotplåster 00242/0193 Durogesic DTrans 50ug/hrNL/H/3915/004 Sweden 12485 Durogesic 75 mikrogram/timme depotplåster 00242/0194 Durogesic DTrans 75ug/hrNL/H/3915/005 Sweden 12486 Durogesic 100 mikrogram/timme depotplåster 00242/0195 Durogesic DTrans 100ug/hrNL/H/1458/001 Sweden 12771 Cozaar Comp 50mg/12,5mg filmdragerade tabletter 00025/0338 Cozaar Comp 50mg/12.5mgNL/H/1539/002 Sweden 12790 Lamictal 5mg dispergerbar tablett 00003/0346 Lamictal 5mg dispersible tabsNL/H/1539/003 Sweden 12791 Lamictal 25mg dispergerbar tablett 00003/0347 Lamictal 25mg dispersible tabsNL/H/1539/005 Sweden 12792 Lamictal 100mg dispergerbar tablett 00003/0348 Lamictal 100mg dispersible tabs

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductNL/H/1539/004 Sweden 13028 Lamictal 50mg dispergerbar tablett 00003/0368 Lamictal 50mg dispersible tabsSE/H/1821/001 Sweden 13216 Nasonex 50 mikrogram/dos, nässpray, suspension 00025/0587 Nasonex 50ug/actuation nasal sprayNL/H/4790/001 Sweden 13259 Zanidip 10 mg filmdragerade tabletter 04595/0005 Zanidip 10mg tabsFI/H/1029/001 Sweden 13276 Arthrotec forte 00057/0932 Arthrotec 75 tabsIE/H/0838/001 Sweden 13358 Sporanox 10mg/ml oral lösning 00242/0307 Sporanox LiquidDE/H/6220/001 Sweden 13488 Malarone 250 mg/100 mg filmdragerade tabletter 10949/0258 Malarone tabsDE/H/4019/001 Sweden 13540 Sandimmun Neoral 10mg mjuka kapslar 00101/0483 Neoral 10mg soft capsNL/H/1457/001 Sweden 13718 Cozaar 12.5mg filmdragerad tablett 00025/0515 Cozaar 12.5mg tabsSE/H/0565/001 Sweden 14098 Diovan Comp 80 mg/12,5 mg filmdragerade tabletter 00101/0480 Co-Diovan 80/12.5mg tabsSE/H/0169/002 Sweden 14592 Seretide Diskus 50 mikrogram/250 mikrogram/dos 10949/0315 Seretide 250 AccuhalerSE/H/0169/003 Sweden 14593 Seretide Diskus forte 50 mikrogram/500 mikrogram 10949/0316 Seretide 500 AccuhalerNL/H/1458/003 Sweden 14654 Cozaar Comp Forte 100mg/25mg filmdragerade tabletter 00025/0374 Cozaar Comp 100mg/25mgNL/H/0150/001 Sweden 14924 Nexplanon, 68 mg implantat för subdermal användning 00025/0563 NexplanonSE/H/0225/001 Sweden 15588 Zaditen 0,25 mg/ml, ögondroppar, lösning 20162/0019 Zaditen 0.25mg/ml eye dropsSE/H/1843/001 Sweden 16267 Zidoval 7,5mg/g vaginalgel 46302/0153 Zidoval 7.5mg/g Vaginal gelDE/H/5646/001 Sweden 17010 Caverject Dual 10 mikrogram pulver och vätska till injektionsvätska, lösning 00057/0939 Caverject DCS 10ugDE/H/5646/002 Sweden 17011 Caverject Dual 20 mikrogram pulver och vätska till injektionsvätska, lösning 00057/0940 Caverject DCS 20ugNL/H/1457/003 Sweden 17386 Cozaar 100mg filmdragerad tablett 00025/0416 Cozaar 100mg tabsSE/H/0406/003 Sweden 17494 Diovan 80mg filmdragerade tabletter 00101/0600 Diovan 80mg tabsSE/H/0406/004 Sweden 17495 Diovan 160mg filmdragerade tabletter 00101/0601 Diovan 160mg tabsNL/H/0299/001 Sweden 18094 Spiriva 18 mikrogram inhalationspulver, hård kapsel 14598/0062 Spiriva 18mcg inhalation powderNL/H/0156/001 Sweden 18958 Seroquel 25mg filmdragerade tabletter 50827/0002 Seroquel 25mg tabsNL/H/0156/002 Sweden 18959 Seroquel 100mg filmdragerade tabletter 50827/0003 Seroquel 100mg tabsNL/H/0156/003 Sweden 18960 Seroquel 200mg filmdragerade tabletter 50827/0004 Seroquel 200mg tabsNL/H/0156/007 Sweden 18961 Seroquel 300mg filmdragerade tabletter 50827/0005 Seroquel 300mg tabsNL/H/4790/002 Sweden 19046 Zanidip 20 mg filmdragerade tabletter 04595/0010 Zanidip 20mg tabsDE/H/5770/002 Sweden 19166 Seretide Evohaler 25 mikrogram/125 mikrogram/dos inhalationsspray 10949/0338 Seretide 125 EvohalerDE/H/5770/003 Sweden 19167 Seretide Evohaler 25 mikrogram/250 mikrogram/dos inhalationsspray 10949/0339 Seretide 250 EvohalerSE/H/0565/002 Sweden 19525 Diovan Comp 160 mg/12,5 mg filmdragerade tabletter 00101/0650 Co-Diovan 160/12.5mg tabsSE/H/0406/005 Sweden 20464 Diovan 40mg filmdragerade tabletter 00101/0599 Diovan 40mg tabsNL/H/0487/001 Sweden 20617 Vesicare 5mg tabletter 00166/0197 Vesicare 5mg tabsNL/H/0487/002 Sweden 20618 Vesicare 10mg tabletter 00166/0198 Vesicare 10mg tabsFI/H/0313/001 Sweden 20890 Nebido 1000mg/4ml injektionsvätska lösning 00010/0549 Nebido 1000mg/4ml injSE/H/0565/003 Sweden 21204 Diovan Comp 160 mg/25 mg filmdragerade tabletter 00101/0651 Co-Diovan 160/25mg tabsNL/H/3915/001 Sweden 21308 Durogesic 12 mikrogram/timme depotplåster 00242/0409 Durogesic DTrans 12ug/hrFI/H/0981/001 Sweden 22413 Tobrasone 3 mg/ml/1 mg/ml ögondroppar, suspension 00101/1007 Tobradex eye dropsNL/H/1458/002 Sweden 22490 Cozaar Comp 100mg/12,5mg filmdragerade tabletter 00025/0473 Cozaar Comp 100mg/12.5mgSE/H/0406/006 Sweden 22840 Diovan 320mg filmdragerade tabletter 00101/0726 Diovan 320mg tabsIE/H/0574/001 Sweden 22988 Rectogesic 4mg/g 16508/0037 Rectogesic ointmentNL/H/0732/001 Sweden 23419 Mezavant 1200 mg enterodepottabletter 08081/0040 Mezavant XL 1200mg tabsDE/H/0690/001 Sweden 23835 Medikinet 5mg tabletter 11243/0002 Medikinet 5mg tabsDE/H/0690/002 Sweden 23836 Medikinet 10mg tabletter 11243/0003 Medikinet 10mg tabsDE/H/0690/003 Sweden 23837 Medikinet 20mg tabletter 11243/0004 Medikinet 20mg tabsDE/H/0690/004 Sweden 23840 Medikinet 10 mg, kapsel med modifierad frisättning, hård 11243/0005 Medikinet XL 10mg capsDE/H/0690/005 Sweden 23841 Medikinet 20 mg, kapsel med modifierad frisättning, hård 11243/0006 Medikinet XL 20mg capsDE/H/0690/006 Sweden 23842 Medikinet 30 mg, kapsel med modifierad frisättning, hård 11243/0007 Medikinet XL 30mg capsDE/H/0690/007 Sweden 23843 Medikinet 40 mg, kapsel med modifierad frisättning, hård 11243/0008 Medikinet XL 40mg capsNL/H/0718/001 Sweden 24315 Spiriva Respimat 2,5 mikrogram inhalationsvätska, lösning 14598/0084 Spiriva Respimat

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Procedure No Source Country ECMA No Imported Name UK PL No UK ProductDE/H/5733/001 Sweden 25314 Versatis 700mg medicinskt plåster 21727/0016 Versatis 700mg medicated plasterNL/H/0156/008 Sweden 25986 Seroquel Depot 50mg depottabletter 50827/0006 Seroquel XL 50mg tabsNL/H/0156/009 Sweden 25987 Seroquel Depot 200mg depottabletter 50827/0008 Seroquel XL 200mg tabsNL/H/0156/010 Sweden 25988 Seroquel Depot 300mg depottabletter 50827/0009 Seroquel XL 300mg tabsNL/H/0156/011 Sweden 25989 Seroquel Depot 400mg depottabletter 50827/0010 Seroquel XL 400mg tabsNL/H/0156/012 Sweden 26908 Seroquel Depot 150mg depottabletter 50827/0007 Seroquel XL 150mg tabsDE/H/2020/004 Sweden 42624 Palexia Depot 50mg depottabletter 21727/0041 Palexia SR 50mg tabsDE/H/2020/005 Sweden 42625 Palexia Depot 100mg depottabletter 21727/0042 Palexia SR 100mg tabsDE/H/2020/006 Sweden 42626 Palexia Depot 150mg depottabletter 21727/0043 Palexia SR 150mg tabsDE/H/2020/007 Sweden 42627 Palexia Depot 200mg depottabletter 21727/0044 Palexia SR 200mg tabsDE/H/2020/008 Sweden 42628 Palexia Depot 250mg depottabletter 21727/0045 Palexia SR 250mg tabsDK/H/2871/001 Sweden 43543 Picoprep 03194/0014 PicolaxDE/H/0690/008 Sweden 44810 Medikinet 5 mg, kapsel med modifierad frisättning, hård 11243/0010 Medikinet XL 5mg capsSE/H/1074/001 Sweden 45850 Latanoprost/Timolol Pfizer 50 mikrogram/ml + 5 mg/ml ögondroppar, lösning 00057/1322 Latanoprost/Timolol Pfizer 50+5 ug/mlSE/H/1342/001 Sweden 46033 Hidrasec 30mg granules for oral suspension 39418/0002 Hidrasec Children 30mg granulesDE/H/2020/009 Sweden 46138 Palexia Depot 25mg depottabletter 21727/0051 Palexia SR 25mg tabsDE/H/3355/001 Sweden 47084 Dymista125 mikrogram + 50 mikrogram/sprayning nässpray, suspension 15142/0258 Dymista Nasal SprayNL/H/2564/001 Sweden 48093 Propranolol Accord 10mg filmdragerade tabletter 20075/0360 Propranolol 10mg tabsNL/H/2564/002 Sweden 48094 Propranolol Accord 40mg filmdragerade tabletter 20075/0361 Propranolol 40mg tabsDK/H/2028/001 Sweden 48201 Methylphenidate Sandoz 18mg depottabletter 04416/1346 Matoride XL 18mg tabsDK/H/2028/002 Sweden 48202 Methylphenidate Sandoz 36mg depottabletter 04416/1348 Matoride XL 36mg tabsDK/H/2028/003 Sweden 48203 Methylphenidate Sandoz 54mg depottabletter 04416/1349 Matoride XL 54mg tabsDK/H/0134/003 Sweden 56217 Cosopt sine 20mg/ml + 5mg/ml ögondroppar, lösning 16058/0025 Cosopt iMultiAT/H/0754/001 Sweden 56488 Klexane 12 000IE (120mg)/0,8ml injektionsvätska, lösning, förfylld spruta 04425/0185 Clexane Forte 12000IU (120mg)/0.8mlAT/H/0754/002 Sweden 56489 Klexane 15 000IE (150mg)/1ml injektionsvätska, lösning, förfylld spruta 04425/0185 Clexane Forte 15000IU (150mg)/1ml

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Documents

Parallel Import MR-DC List...Parallel Import MR-DC List Procedure No Source Country ECMA No Imported Name UK PL No UK Product DE/H/0523/001 Austria 1-26158 Olmetec Plus 20mg/12.5mg