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An agency of the European Union
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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
26 October 2017 EMA/663700/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: cromoglicic acid
Procedure no.: PSUSA/00000883/201702
List of nationally authorised medicinal products EMA/663700/2017 Page 2/26
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Alleofta 20 mg/ml kapi za oko, otopina u jednodoznom spremniku
UK/H/5451/001 HR-H-586030470 SANOFI-AVENTIS CROATIA D.O.O.
HR
Alleofta 20 mg/ml kapi za oko, otopina u jednodoznom spremniku
UK/H/5451/001 HR-H-586030470 SANOFI-AVENTIS CROATIA D.O.O.
HR
Alleophta 20 mg/ml, očná roztoková instilácia v jednodávkovom obale
UK/H/5451/001 64/0414/16-S SANOFI-AVENTIS SLOVAKIA SRO
SK
Alleophta 20 mg/ml, očná roztoková instilácia v jednodávkovom obale
UK/H/5451/001 64/0414/16-S SANOFI-AVENTIS SLOVAKIA SRO
SK
Alleophta unidosis 20 mg/ml, collyre en solution en récipient unidose
UK/H/5451/01/DC BE467022 SANOFI BELGIUM BE
Alleophta unidosis 20 mg/ml, collyre en solution en récipient unidose
UK/H/5451/01/DC BE467022 SANOFI BELGIUM BE
Alleophta unidosis 20 mg/ml, collyre en solution en récipient unidose
UK/H/5451/01/DC 0780335 SANOFI BELGIUM LU
Alleophta unidosis 20 mg/ml, collyre en solution en récipient unidose
UK/H/5451/01/DC 0780321 SANOFI BELGIUM LU
List of nationally authorised medicinal products EMA/663700/2017 Page 3/26
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Alleophta unidosis 20 mg/ml, oogdruppels, oplossing in verpakking voor éénmalig gebruik
UK/H/5451/01/DC BE467022 SANOFI BELGIUM BE
Alleophta unidosis 20 mg/ml, oogdruppels, oplossing in verpakking voor éénmalig gebruik
UK/H/5451/01/DC BE467022 SANOFI BELGIUM BE
Alleopti 20 mg/ ml oldatos szemcsepp
not available OGYI-T-22584/01 SANOFI-AVENTIS ZRT HU
ALLEOPTI 20 MG/ML OLDATOS SZEMCSEPP
not available OGYI-T-22584/04 SANOFI-AVENTIS ZRT HU
Alleopti Komfort 20 mg/ ml oldatos szemcsepp egyadagos tartályban
not available OGYI-T-22584/03 SANOFI-AVENTIS ZRT HU
Alleopti Komfort 20 mg/ ml oldatos szemcsepp egyadagos tartályban
not available OGYI-T-22584/02 SANOFI-AVENTIS ZRT HU
Alleoptical, 20 mg/ml, krople do oczu, roztwór w pojemniku jednodawkowym
UK/H/5451/01/DC 22656 AVENTIS PHARMA LTD PL
Alleoptical, 20 mg/ml, krople do oczu, roztwór w pojemniku jednodawkowym
UK/H/5451/01/DC 22656 AVENTIS PHARMA LTD PL
List of nationally authorised medicinal products EMA/663700/2017 Page 4/26
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Allerg-Abak 20 mg/ml oogdruppels, oplossing
FR/H/0234/001 RVG 29812 LABORATOIRES THEA NL
Allergo-COMOD eye drops not available MA063/00201 URSAPHARM ARZNEIMITTEL GMBH
MT
Allergo-COMOD neusspray not available RVG 15592 URSAPHARM BENELUX B.V. NL
Allergo-COMOD ocní kapky, Oční kapky, roztok
not available 64/020/01-C URSAPHARM SPOL. S.R.O. CZ
Allergo-COMOD oogdruppels not available RVG 15461 URSAPHARM BENELUX B.V. NL
Allergo-COMOD, 20 mg/ml, krople do oczu, roztwór
not available 9762 URSAPHARM POLAND SP. Z. O.O.
PL
ALLERGOCOMOD, collyre en solution
not available 354 293-1 LABORATOIRES URSAPHARM S.A.S.
FR
Allergo-COMOD® Augentropfen
not available 1-24846 URSAPHARM GES.M.B.H. AT
Allergo-COMOD® Nasenspray
not available 1-24841 URSAPHARM GES.M.B.H. AT
Allergocrom not available 64/0662/94-S URSAPHARM ARZNEIMITTEL GMBH
SK
Allergocrom nosní sprej, Nosní sprej, roztok
not available 69/945/97-C URSAPHARM SPOL. S.R.O. CZ
Allergocrom oční kapky, roztok
not available 64/072/97-C URSAPHARM SPOL. S.R.O. CZ
List of nationally authorised medicinal products EMA/663700/2017 Page 5/26
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Allergocrom, 20 mg/ml, krople do oczu, roztwór
not available 8980 URSAPHARM POLAND SP. Z. O.O.
PL
Allergoval Kapseln not available 16619.00.03 KOEHLER PHARMA GMBH DE
Allgil 20 mg/ml ögondroppar, lösning
not available 48236 APOFRI AB SE
Aspire Allergy Relief 2% w/v eye drops, Solution (eye drops)
not available PL 35533/0033 ASPIRE PHARMA LIMITED UK
Aspire Hayfever Relief 2% w/v Eye Drops
not available PL 35533/0031 ASPIRE PHARMA LIMITED UK
Boots Allergy Relief 2% w/v Eye Drops
not available PL03468/0023 BAUSCH & LOMB UK LTD. UK
Boots Hayfever Relief 2% w/v Eye Drops
not available PL 35533/0031 ASPIRE PHARMA LIMITED UK
Catacrom 2% w/v eye drops, solution
UK/H/1718/001 PA 1464/1/1 RAYNER PHARMACEUTICALS IE
Catacrom 2% w/v eye drops, solution
UK/H/1718/001 PL11412/0002 MOORFIELDS EYE HOSPITAL NHS FOUNDATION TRUST
UK
COLIMUNE SACHETS 100 MG
not available 355.00.01 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
COLIMUNE SACHETS 100 MG
not available 355.00.01 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
List of nationally authorised medicinal products EMA/663700/2017 Page 6/26
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
COLIMUNE SACHETS 100 MG
not available 355.00.01 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
COLIMUNE SACHETS 200 MG
not available 355.01.01 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
COLIMUNE SACHETS 200 MG
not available 355.01.01 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
COLIMUNE SACHETS 200 MG
not available 355.01.01 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
CROMABAK 20 mg/ml colirio en solución
FR/H/0234/001 65867 LABORATOIRES THEA ES
CROMABAK 20 mg/ml collirio soluzione
FR/H/0234/001 036592020 LABORATOIRES THEA IT
Cromabak 20 mg/ml collyre en solution
not available BE206333 THEA PHARMA BE
Cromabak 20 mg/ml collyre en solution
not available BE206333 THEA PHARMA LU
Cromabak 20 mg/ml oogdruppels, oplossing
not available BE206333 THEA PHARMA BE
Cromabak 20 mg/ml, colírio, solução
not available 2612588 LABORATOIRES THEA PT
Cromabak 20 mg/ml, colírio, solução
not available 2612687 LABORATOIRES THEA PT
List of nationally authorised medicinal products EMA/663700/2017 Page 7/26
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
CROMABAK 20 mg/ml, collyre en solution
FR/H/0234/001 34009 340 530 6 1 LABORATOIRES THEA FR
Crominet 20 mg/ml ögondroppar, lösning
SE/H/1372/001 49988 ORIFARM GENERICS A/S SE
Crominet 20 mg/ml øyedråper, oppløsning
SE/H/1372/001 13-9749 ORIFARM GENERICS A/S NO
Crominet, øjendråber, opløsning
SE/H/1372/001 53098 ORIFARM GENERICS A/S DK
CROMOFREE 2 %, collyre en solution
not available 34009 346 922 3 9 LABORATOIRE CHAUVIN FR
Cromoglicato de Sodio Brown 20 mglml colirio, solucao
UK/H/3500/001 5444906 BROWN & BURK UK LIMITED PT
Cromoglicato de Sodio Brown 20 mglml colirio, solucao
UK/H/3500/001 5444914 BROWN & BURK UK LIMITED PT
CROMOHEXAL not available 64/142/96-C LABORATOIRES THEA CZ
CROMOHEXAL 20 mg/1 ml Nosní sprej, roztok
not available 24/141/96-C HEXAL AG CZ
Cromolux 2% Eye Drops not available PL 03468/0022 BAUSCH & LOMB UK LTD. UK
Cromolux 2% Hay fever Eye Drops
not available PL03468/0023 BAUSCH & LOMB UK LTD. UK
List of nationally authorised medicinal products EMA/663700/2017 Page 8/26
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Crom-Ophtal® 1 ml Augentropfen enthält 20 mg Natriumcromoglicat (Ph.Eur.)
not available 7974.00.00 DR. WINZER PHARMA GMBH DE
Crom-Ophtal® Nasenspray not available 7975.00.00 DR. WINZER PHARMA GMBH DE
Crom-Ophtal® sine 1 ml Augentropfen enthält 20 mg Natriumcromoglicat (Ph.Eur.)
not available 24158.00.00 DR. WINZER PHARMA GMBH DE
CROMOPTIC 2 %, collyre en solution
not available 345 917-6 LABORATOIRE CHAUVIN FR
CROMOPTIC 2 %, collyre en solution en récipient unidose
not available 34009 353 566 4 2 LABORATOIRE CHAUVIN FR
CUSICROM FUERTE OFTÁLMICO 40 mg/ml colirio en solución
not available 57327 NOVARTIS FARMACÉUTICA S.A.
ES
EM Pharma Allergy Relief 2%w/v Eye Drops, Solution (eye drops)
not available PL 35533/0033 ASPIRE PHARMA LIMITED UK
EM Pharma Hayfever Relief 2%w/v Eye Drops
not available PL 35533/0031 ASPIRE PHARMA LIMITED UK
Fenolip 20 mg/ml solução para inalação por nebulização
not available 8707505 ANGELINI FARMACÊUTICA, LDA
PT
List of nationally authorised medicinal products EMA/663700/2017 Page 9/26
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Fenolip, 10 mg / 0,5 ml, colírio, solução
not available 2910883 ANGELINI FARMACÊUTICA, LDA
PT
Fenolip, 20 mg/ml, colírio, solução
not available 8707406 ANGELINI FARMACÊUTICA, LDA
PT
INTAL CFC-FREE INHALER not available PL 04425/0179 AVENTIS PHARMA LTD UK
INTAL INHALATIONLÖSUNG 1%
not available 7835.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
INTAL INHALATIONLÖSUNG 1%
not available 7835.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
INTAL INHALATIONLÖSUNG 1%
not available 7835.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
INTAL INHALATIONLÖSUNG 1%
not available 7835.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
INTAL N AEROSOL not available 354.00.01 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
INTAL N AEROSOL not available 354.00.01 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
INTAL N AEROSOL not available 354.00.01 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
INTAL N AEROSOL not available 354.00.01 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
List of nationally authorised medicinal products EMA/663700/2017 Page 10/26
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
INTAL N AEROSOL not available 354.00.01 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
INTAL N AEROSOL not available 354.00.01 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
INTAL N AEROSOL not available 354.00.01 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
Lecrolyn not available 15022 SANTEN OY DK
LECROLYN 20 mg/ml – acu pilieni, šķīdums
not available 99-0312 SANTEN OY LV
LECROLYN 20 mg/ml akių lašai (tirpalas)
not available LT/1/96/2408/001 SANTEN OY LT
Lecrolyn 20 mg/ml ögondroppar, lösning, endosbehållare
not available 11459 SANTEN OY SE
LECROLYN 20 mg/ml silmatilgad, lahus
not available 103795 SANTEN OY EE
LECROLYN 20 mg/ml -silmätipat, liuos
not available 11026 SANTEN OY FI
LECROLYN 40 mg/ml – acu pilieni, šķīdums
not available 99-0314 SANTEN OY LV
LECROLYN 40 mg/ml akių lašai (tirpalas)
not available LT/1/96/2408/002 SANTEN OY LT
List of nationally authorised medicinal products EMA/663700/2017 Page 11/26
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
LECROLYN 40 mg/ml akių lašai, tirpalas
not available LT/1/96/2408/004 SANTEN OY LT
LECROLYN 40 mg/ml akių lašai, tirpalas
not available LT/1/96/2408/005 SANTEN OY LT
Lecrolyn 40 mg/ml ögondroppar, lösning
not available 12128 SANTEN OY SE
Lecrolyn 40 mg/ml ögondroppar, lösning, endosbehållare
not available 12129 SANTEN OY SE
Lecrolyn 40 mg/ml øyedråper, oppløsning i dråpeflaske
not available 8306 SANTEN OY NO
Lecrolyn 40 mg/ml øyedråper, oppløsning i endosebeholdere
not available 03-2101 SANTEN OY NO
LECROLYN 40 mg/ml silmatilgad, lahus
not available 103995 SANTEN OY EE
LECROLYN 40 mg/ml -silmätipat, liuos
not available 11503 SANTEN OY FI
Lecrolyn sine 40 mg/ml akių lašai (tirpalas)
SE/H/1402/001 LT/1/15/3711/001 SANTEN OY LT
Lecrolyn sine 40 mg/ml akių lašai (tirpalas)
SE/H/1402/001 LT/1/15/3711/002 SANTEN OY LT
List of nationally authorised medicinal products EMA/663700/2017 Page 12/26
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Lecrolyn sine 40 mg/ml akių lašai (tirpalas)
SE/H/1402/001 LT/1/15/3711/003 SANTEN OY LT
Lecrolyn sine 40 mg/ml augndropar, lausn
SE/H/1402/01/DC IS/1/15/035/01 SANTEN OY IS
Lecrolyn sine 40 mg/ml ögondroppar, lösning
SE/H/1402/001 32110 SANTEN OY FI
Lecrolyn sine 40 mg/ml ögondroppar, lösning
SE/H/1402/001 50887 SANTEN OY SE
Lecrolyn sine 40 mg/ml øyedråper, oppløsning
SE/H/1402/01/DC 14-9996 SANTEN OY NO
Lecrolyn sine 40 mg/ml silmatilgad, lahus
SE/H/1402/001 894915 SANTEN OY EE
Lecrolyn sine 40 mg/ml silmätipat, liuos
SE/H/1402/01/DC 32110 SANTEN OY FI
Lecrolyn sine, øjendråber, opløsning
SE/H/1402/001 53827 SANTEN OY DK
Lecrolyn, øjendråber, opløsning
not available 14960 SANTEN OY DK
LECROLYN® 20 mg/ml ögondroppar, lösning
not available 11026 SANTEN OY FI
LECROLYN® 20 mg/ml ögondroppar, lösning i endosbehållare
not available 11027 SANTEN OY FI
List of nationally authorised medicinal products EMA/663700/2017 Page 13/26
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
LECROLYN® 20 mg/ml -silmätipat, liuos kerta-annospakkauksessa
not available 11027 SANTEN OY FI
LECROLYN® 40 mg/ml ögondroppar, lösning
not available 11503 SANTEN OY FI
LECROLYN® 40 mg/ml ögondroppar, lösning i endosbehållare
not available 11504 SANTEN OY FI
LECROLYN® 40 mg/ml -silmätipat, liuos kerta-annospakkauksessa
not available 11504 SANTEN OY FI
LOMUDAL not available MT 10015 SANOFI-AVENTIS DENMARK A/S
DK
LOMUDAL not available 022319038 SANOFI SPA IT
LOMUDAL not available 8593 SANOFI AB SE
LOMUDAL 20 MG not available RVG 05719 SANOFI-AVENTIS NETHERLANDS B.V.
NL
LOMUDAL 20 MG not available RVG 05719 SANOFI-AVENTIS NETHERLANDS B.V.
NL
Lomudal 20 mg inhalationspulver, hård kapsel
not available 8593 SANOFI AB SE
List of nationally authorised medicinal products EMA/663700/2017 Page 14/26
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Lomudal 20 mg inhalationspulver, hård kapsel
not available 8593 SANOFI AB SE
LOMUDAL 20 mg, solution pour inhalation par nébuliseur
not available BE110503 SANOFI BELGIUM BE
Lomudal 20 mg, verneveloplossing
not available BE110503 SANOFI BELGIUM BE
Lomudal 20 mg/ml ögondroppar, lösning
not available 9326 SANOFI AB SE
Lomudal 20 mg/ml ögondroppar, lösning
not available 9326 SANOFI AB SE
Lomudal 20 mg/ml øyedråper, oppløsning
not available 6300 SANOFI-AVENTIS NORGE AS NO
Lomudal 20 mg/ml øyedråper, oppløsning
not available 6300 SANOFI-AVENTIS NORGE AS NO
Lomudal 20 mg/ml øyedråper, oppløsning
not available 6300 SANOFI-AVENTIS NORGE AS NO
LOMUDAL 20 MG/ML SILMATIPAT, LIUOS
not available 7589 SANOFI OY FI
LOMUDAL 20 MG/ML SILMATIPAT, LIUOS
not available 7589 SANOFI OY FI
List of nationally authorised medicinal products EMA/663700/2017 Page 15/26
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Lomudal 20 mg/ml, augndropar, lausn
not available 792354 SANOFI-AVENTIS NORGE AS IS
Lomudal 40 mg/ml ögondroppar, lösning, endosbehållare
not available 11683 SANOFI AB SE
Lomudal 40 mg/ml ögondroppar, lösning, endosbehållare
not available 11683 SANOFI AB SE
Lomudal 40 mg/ml øyedråper, oppløsning i endosebeholder
not available 7842 SANOFI-AVENTIS NORGE AS NO
Lomudal 40 mg/ml øyedråper, oppløsning i endosebeholder
not available 7842 SANOFI-AVENTIS NORGE AS NO
LOMUDAL 40 MG/ML SILMATIPAT, LIUOS KERTA-ANNOSPIPETISSA
not available 11080 SANOFI OY FI
LOMUDAL 40 MG/ML SILMATIPAT, LIUOS KERTA-ANNOSPIPETISSA
not available 11080 SANOFI OY FI
LOMUDAL 40mg/ml collirio, soluzione
not available 022319065 SANOFI SPA IT
LOMUDAL 40mg/ml spray nasale, soluzione
not available 022319077 SANOFI SPA IT
List of nationally authorised medicinal products EMA/663700/2017 Page 16/26
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
LOMUDAL FORTE not available RVG 11817 SANOFI-AVENTIS NETHERLANDS B.V.
NL
LOMUDAL FREONITON 5 MG/ANNOS INHALAATIOSUMUTE, SUSPENSIO
not available 13264 SANOFI OY FI
LOMUDAL G.I. not available 10468 SANOFI AB SE
LOMUDAL G.I. not available 10468 SANOFI AB SE
LOMUDAL NASAL not available 13636 SANOFI-AVENTIS DENMARK A/S
DK
LOMUDAL NASAL not available 10971 SANOFI AB SE
LOMUDAL NASAL not available 10971 SANOFI AB SE
LOMUDAL NASAL 5,2 MG/ANNOS NENASUMUTE, LIUOS
not available 11373 SANOFI OY FI
LOMUDAL NASAL 5,2 MG/ANNOS NENASUMUTE, LIUOS
not available 11373 SANOFI OY FI
Lomudal Nasal 5,2 mg/dose nesespray, oppløsning
not available 00/7496 SANOFI-AVENTIS NORGE AS NO
Lomudal Nasal 5,2 mg/dose nesespray, oppløsning
not available 00/7496 SANOFI-AVENTIS NORGE AS NO
List of nationally authorised medicinal products EMA/663700/2017 Page 17/26
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
LOMUDAL NEBULISER SOL. FOR INH. (GLASS VIALS)
not available 0067254 SANOFI BELGIUM LU
Lomudal, øjendråber, opløsning
not available 09241 SANOFI-AVENTIS DENMARK A/S
DK
Lomudal, øjendråber, opløsning
not available 09241 SANOFI-AVENTIS DENMARK A/S
DK
Lomudal, øjendråber, opløsning, enkeltdosisbeholder
not available 38011 SANOFI-AVENTIS DENMARK A/S
DK
Lomudal, øjendråber, opløsning, enkeltdosisbeholder
not available 38011 SANOFI-AVENTIS DENMARK A/S
DK
LOMUDAL, SOLUTION POUR NEBULISATION
not available 324 118-7 SANOFI-AVENTIS FRANCE FR
LOMUDAL, SOLUTION POUR NEBULISATION
not available 324 119-3 SANOFI-AVENTIS FRANCE FR
Lomudal® Gastrointestinum 100 mg kapselit
not available 8299 ITALCHIMICI S.P.A. FI
LOMUSOL 2% not available 0006/09100548 SANOFI BELGIUM LU
Lomusol 2% neusdruppels, oplossing
not available BE158706 SANOFI BELGIUM BE
Lomusol 2% solution pour instillation nasale
not available BE158706 SANOFI BELGIUM BE
List of nationally authorised medicinal products EMA/663700/2017 Page 18/26
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
LOMUSOL 4 POUR CENT, solution pour pulvérisation nasale
not available 337 537.3 SANOFI-AVENTIS FRANCE FR
LOMUSOL 4 POUR CENT, solution pour pulvérisation nasale
not available 337 539.6 SANOFI-AVENTIS FRANCE FR
Lomusol 4% neusspray, oplossing
not available BE172207 SANOFI BELGIUM BE
Lomusol 4% solution pour pulvérisation nasale
not available BE172207 SANOFI BELGIUM BE
LOMUSOL 4% SPRAY not available 0216291 SANOFI BELGIUM LU
MULTICROM 2 %, collyre en solution
not available 34009 340 532 9 0 LABORATOIRES THEA FR
MULTICROM UNIDOSES 2 POUR CENT, collyre en récipient unidose
not available 348 847-9 LABORATOIRES THEA FR
MULTICROM UNIDOSES 2 POUR CENT, collyre en récipient unidose
not available 349 775-1 LABORATOIRES THEA FR
MULTICROM UNIDOSES 2 POUR CENT, collyre en récipient unidose
not available 357 483-6 LABORATOIRES THEA FR
List of nationally authorised medicinal products EMA/663700/2017 Page 19/26
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
MULTICROM UNIDOSES 2 POUR CENT, collyre en récipient unidose
not available 357 087-3 LABORATOIRES THEA FR
NALCROM not available RVG 10227 SANOFI-AVENTIS NETHERLANDS B.V.
NL
NALCROM not available RVG 10228 SANOFI-AVENTIS NETHERLANDS B.V.
NL
NALCROM not available 14/0305/89-S ITALCHIMICI S.P.A. SK
Nalcrom 100 mg capsule rigide
not available 024861015 ITALCHIMICI S.P.A. IT
Nalcrom 100 mg, tvrdé tobolky
not available 14/305/89-S/C ITALCHIMICI S.P.A. CZ
NALCROM 100MG CAPSULES not available PL 04425/0370 AVENTIS PHARMA LTD UK
Nalcrom 250 mg granulato per soluzione orale
not available 024861039 ITALCHIMICI S.P.A. IT
NALCROM 250 mg granulato per soluzione orale
not available 024861066 ITALCHIMICI S.P.A. IT
Nalcrom 500 mg granulato per soluzione orale
not available 024861041 ITALCHIMICI S.P.A. IT
NALCROM 500 mg granulato per soluzione orale
not available 024861078 ITALCHIMICI S.P.A. IT
List of nationally authorised medicinal products EMA/663700/2017 Page 20/26
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
NALCROM DRANK 100 MG not available RVG 12446 SANOFI-AVENTIS NETHERLANDS B.V.
NL
NALCROM DRANK 200 MG not available RVG 12447 SANOFI-AVENTIS NETHERLANDS B.V.
NL
Natriumcromoglicaat Apotex 20 mg/ml
not available RVG 23703 APOTEX EUROPE B.V. NL
NATRIUMCROMOGLICAAT OOGDRUPPELS 20 G/ML
not available RVG 57336 BASIC PHARMA MANUFACTURING BV
NL
Natriumkromoglikat ABECE 20 mg/ml ögondroppar, lösning
not available 55367 EVOLAN PHARMA AB SE
Numark Hayfever Relief 2% w/v Eye Drops
not available PL 35533/0031 ASPIRE PHARMA LIMITED UK
OPHTACALM 2 %, collyre en solution en récipient unidose
not available 34009 353 567 0 3 LABORATOIRE CHAUVIN FR
OPHTACALM 2 %, collyre en solution en récipient unidose
not available 34009 353 568 7 1 LABORATOIRE CHAUVIN FR
OPHTACALM 2 %, collyre en solution en récipient unidose
not available 34009 353 569 3 2 LABORATOIRE CHAUVIN FR
OPHTACALMFREE 2%, collyre en solution
not available 34009 346 921 7 8 LABORATOIRE CHAUVIN FR
OPTICROM not available RVG 07564 SANOFI-AVENTIS NETHERLANDS B.V.
NL
List of nationally authorised medicinal products EMA/663700/2017 Page 21/26
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
OPTICROM 2 % collyre en solution
not available BE111343 MELISANA NV BE
OPTICROM 2 % collyre en solution
not available 0082619 MELISANA NV LU
OPTICROM 2 % oogdruppels, oplossing Natrium cromoglicaat
not available BE111343 MELISANA NV BE
Opticrom 2% Augentropfen not available BE111343 MELISANA NV BE
Opticrom 2% Augentropfen not available 0082619 MELISANA NV LU
Opticrom 20 mg/ ml oldatos szemcsepp
not available OGYI-T-3691/02 SANOFI-AVENTIS ZRT HU
Opticrom 20 mg/ml colirio en solución en envase unidosis
UK/H/5451/01/DC 80267 SANOFI-AVENTIS, S.A. ES
Opticrom 20 mg/ml colirio en solución en envase unidosis
UK/H/5451/01/DC 80267 SANOFI-AVENTIS, S.A. ES
Opticrom 20 mg/ml Colírio, solução em frasco conta-gotas multidose
not available 8606004 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Opticrom 20mg/ml Colírio, Solução em Unidose
not available 5593314 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
List of nationally authorised medicinal products EMA/663700/2017 Page 22/26
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Opticrom 20mg/ml Colírio, Solução em Unidose
not available 5593322 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Opticrom Allergy 2%w/v Eye Drops, solution
not available PA 540/116/2 SANOFI-AVENTIS IRELAND LTD
IE
Opticrom Allergy 2%w/v Eye Drops, solution
not available PA 540/116/2 SANOFI-AVENTIS IRELAND LTD
IE
Opticrom Allergy 2%w/v Eye Drops, solution
not available PA 540/116/2 SANOFI-AVENTIS IRELAND LTD
IE
OPTICROM ALLERGY 2.0% W/W EYE DROPS, SOLUTION
not available PL 04425/0323 AVENTIS PHARMA LTD UK
OPTICROM ALLERGY 2.0% W/W EYE DROPS, SOLUTION
not available PL 04425/0323 AVENTIS PHARMA LTD UK
Opticrom Allergy Single Dose 2% w/v Eye Drops, Solution
UK/H/5451/01/DC PA 540/116/3 SANOFI-AVENTIS IRELAND LTD
IE
Opticrom Allergy Single Dose 2% w/v Eye Drops, Solution
UK/H/5451/01/DC PA 540/116/3 SANOFI-AVENTIS IRELAND LTD
IE
Opticrom Allergy Single Dose 2% w/v Eye Drops, Solution
UK/H/5451/01/DC PL 04425/0688 AVENTIS PHARMA LTD UK
List of nationally authorised medicinal products EMA/663700/2017 Page 23/26
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Opticrom Allergy Single Dose 2% w/v Eye Drops, Solution
UK/H/5451/01/DC PL 04425/0688 AVENTIS PHARMA LTD UK
OPTICROM AQUEOUS / VISICROM EYE DROPS
not available PL 04425/0324 AVENTIS PHARMA LTD UK
OPTICROM AQUEOUS / VISICROM EYE DROPS
not available PL 04425/0324 AVENTIS PHARMA LTD UK
OPTICROM EYE DROPS not available PA 540/116/1 SANOFI-AVENTIS IRELAND LTD
IE
OPTICROM EYE DROPS not available PA 540/116/1 SANOFI-AVENTIS IRELAND LTD
IE
OPTICROM EYE DROPS not available PA 540/116/1 SANOFI-AVENTIS IRELAND LTD
IE
OPTICROM HAYFEVER 2% W/V EYE DROPS
not available PL 04425/0628 AVENTIS PHARMA LTD UK
OPTICROM HAYFEVER 2% W/V EYE DROPS
not available PL 04425/0628 AVENTIS PHARMA LTD UK
OPTICROM OLDATOS SZEMCSEPP
not available OGYI-T-3691/01 SANOFI-AVENTIS ZRT HU
OPTICROM UNIT DOSE not available RVG 12039 SANOFI-AVENTIS NETHERLANDS B.V.
NL
OpticromTM Allergy 2.0% w/v Eye Drops, Solution
not available MA 082/01901 SANOFI MALTA LTD MT
List of nationally authorised medicinal products EMA/663700/2017 Page 24/26
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
OpticromTM Allergy 2.0% w/v Eye Drops, Solution
not available MA 082/01901 SANOFI MALTA LTD MT
OPTICRON 2 POUR CENT, collyre
not available 320 298-0 COOPERATION PHARMACEUTIQUE FRANCAISE
FR
OPTICRON UNIDOSE, collyre en récipient unidose
not available 331 357.3 COOPERATION PHARMACEUTIQUE FRANCAISE
FR
Optrex Allergy 2%w/v Eye Drops, Solution (eye drops)
not available PL 35533/0033 ASPIRE PHARMA LIMITED UK
Optrex Allergy Eye Drops (sodium cromoglicate 2%)
not available PL03468/0023 BAUSCH & LOMB UK LTD. UK
Optrex Hayfever Relief 2%w/v Eye Drops
not available PL 35533/0031 ASPIRE PHARMA LIMITED UK
Pollenase Hayfever Relief 2%w/v Eye Drops
not available PL 35533/0031 ASPIRE PHARMA LIMITED UK
SODIO CROMOGLICATO SANOFI
UK/H/5451/01/DC 043692021 SANOFI SPA IT
SODIO CROMOGLICATO SANOFI
UK/H/5451/01/DC 043692019 SANOFI SPA IT
Sodium Cromoglicate 2% w/v Eye Drops, Solution
not available PL 35533/0032 ASPIRE PHARMA LIMITED UK
List of nationally authorised medicinal products EMA/663700/2017 Page 25/26
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Sodium Cromoglicate 2% w/v Eye Drops, Solution
UK/H/3500/001 PL 25298/0033 BROWN & BURK UK LIMITED UK
Sodium Cromoglicate 2% w/v Eye Drops, Solution
UK/H/3500/001 PL 25298/0033 BROWN & BURK UK LIMITED UK
Tesco Allergy Eye Drops sodium cromoglicate 2%
not available PL03468/0023 BAUSCH & LOMB UK LTD. UK
Vivicrom Eye Drops not available PL 03468/0035 BAUSCH & LOMB UK LTD. UK
VIVIDRIN not available 75843/23.12.2015 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
GR
VIVIDRIN not available 75843/23.12.2015 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
GR
Vividrin 2% eye drops not available 11977 DR. GERHARD MANN CHEM.-PHARM. FABRIK GMBH
CY
Vividrin Antiallergic Eye Drops, Solution 2%w/v
not available PA 555/5/2 BAUSCH & LOMB UK LTD. IE
Vividrin Eye Drops not available PL 03468/0035 BAUSCH & LOMB UK LTD. UK
Vividrin Hay Fever Eye Drops
not available PL 03468/0035 BAUSCH & LOMB UK LTD. UK
Vividrin Preservative Free SDU 2% w/v Eye Drops solution
not available PA 555/5/3 BAUSCH & LOMB UK LTD. IE
List of nationally authorised medicinal products EMA/663700/2017 Page 26/26
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Vividrin® antiallergische Augentropfen
not available 4552.00.00 DR. GERHARD MANN CHEM.-PHARM. FABRIK GMBH
DE
Vividrin® antiallergische Augentropfen
not available 1995012984 DR. GERHARD MANN CHEM.-PHARM. FABRIK GMBH
LU
Vividrin® iso EDO® antiallergische Augentropfen
not available 30622.00.00 DR. GERHARD MANN CHEM.-PHARM. FABRIK GMBH
DE
Vividrin® MDO® not available 40229.00.00 DR. GERHARD MANN CHEM.-PHARM. FABRIK GMBH
DE
Vividrin® Nasenspray gegen Heuschnupfen
not available 4553.00.00 DR. GERHARD MANN CHEM.-PHARM. FABRIK GMBH
DE
Vividrin® Nasenspray gegen Heuschnupfen
not available 1989060399 DR. GERHARD MANN CHEM.-PHARM. FABRIK GMBH
LU
