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Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
An agency of the European Union
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© European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.
29 May 2019 EMA/2379050/2019 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: diclofenac (topical formulations)
Procedure no.: PSUSA/00010342/201809
List of nationally authorised medicinal products EMA/379050/2019 Page 2/59
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
Algipatch 140 mg apósitos adhesivos medicamentosos
DE/H/1481/001 71.059 ANGELINI FARMACEUTICA, S.A.
ES
ALGOPAIN-Eze 140 mg medicated plaster
DE/H/1479/001 PL 15773/0711 RATIOPHARM GMBH UK
Algoplast-ratiopharm 140 mg gyógyszeres tapasz
DE/H/1479/001 OGYI-T-20780/01 RATIOPHARM GMBH HU
Algoplast-ratiopharm 140 mg gyógyszeres tapasz
DE/H/1479/001 OGYI-T-20780/02 RATIOPHARM GMBH HU
Algoplast-ratiopharm 140 mg gyógyszeres tapasz
DE/H/1479/001 OGYI-T-20780/04 RATIOPHARM GMBH HU
Algoplast-ratiopharm 140 mg gyógyszeres tapasz
DE/H/1479/001 OGYI-T-20780/03 RATIOPHARM GMBH HU
ALTERFLEX TISSUGEL 140 mg, emplâtre médicamenteux
FR/H/0267/001 34009 367 327 7 3 LABORATOIRES GENEVRIER FR
ALTERFLEX TISSUGEL 140 mg, emplâtre médicamenteux
FR/H/0267/001 34009 367 328 3 4 LABORATOIRES GENEVRIER FR
ALTERFLEX TISSUGEL 140 mg, emplâtre médicamenteux
FR/H/0267/001 34009 367 330 8 4 LABORATOIRES GENEVRIER FR
List of nationally authorised medicinal products EMA/379050/2019 Page 3/59
ALTERFLEX TISSUGEL 140 mg, emplâtre médicamenteux
FR/H/0267/001 34009 367 331 4 5 LABORATOIRES GENEVRIER FR
ANTALCALM 140 mg, emplâtre médicamenteux
DE/H/2677/001 34009 276 207 9 9 PIERRE FABRE MEDICAMENT FR
ANTALCALM 140 mg, emplâtre médicamenteux
DE/H/2677/001 34009 276 205 6 0 PIERRE FABRE MEDICAMENT FR
ANTALCALM 140 mg, emplâtre médicamenteux
DE/H/2677/001 34009 276 206 2 1 PIERRE FABRE MEDICAMENT FR
DENACLOF not available 9752/8-2-2012 LABORATOIRES THEA GR
DENACLOF not available 9752/8-2-2012 LABORATOIRES THEA GR
DENACLOF not available 9752/8-2-2012 LABORATOIRES THEA GR
DENACLOF not available 9752/8-2-2012 LABORATOIRES THEA GR
Dicipan, 10 mg/g, gel not available 5633227 MERNOVIS, SOCIEDADE UNIPESSOAL, LDA.
PT
Dicipan, 10 mg/g, gel not available 5633243 MERNOVIS, SOCIEDADE UNIPESSOAL, LDA.
PT
List of nationally authorised medicinal products EMA/379050/2019 Page 4/59
Dicipan, 10 mg/g, gel not available 5633235 MERNOVIS, SOCIEDADE UNIPESSOAL, LDA.
PT
Diclac Dolo 50 mg/g gél not available OGYI-T-23354/01 SANDOZ HUNGÁRIA KFT HU
Diclac Dolo 50 mg/g gél not available OGYI-T-23354/02 SANDOZ HUNGÁRIA KFT HU
Diclac Dolo 50 mg/g gél not available OGYI-T-23354/03 SANDOZ HUNGÁRIA KFT HU
Diclac Dolo 50 mg/g gél not available OGYI-T-23354/04 SANDOZ HUNGÁRIA KFT HU
Diclo beta Schmerzgel not available 2200471.00.00 BETAPHARM ARZNEIMITTEL GMBH
DE
Dicloabak 1 mg/ml colírio, solução
FR/H/0296/001 5021373 LABORATOIRES THEA PT
Dicloabak 1 mg/ml oogdruppels, oplossing
FR/H/0296/001 RVG 34473 LABORATOIRES THEA NL
Dicloabak 1 mg/ml, collyre en solution
FR/H/0296/001 BE 291225 LABORATOIRES THEA BE
Dicloabak 1 mg/ml, collyre en solution
FR/H/0296/001 1536/07060067 LABORATOIRES THEA LU
List of nationally authorised medicinal products EMA/379050/2019 Page 5/59
DICLOABAK 1 mg/ml, oční kapky, roztok
FR/H/296/01 64/110/11-C LABORATOIRES THEA CZ
Dicloabak 1 mg/ml, ögondroppar, lösning
FR/H/0296/001 44958 LABORATOIRES THEA SE
Dicloabak 1 mg/ml, oogdruppels, oplossing
FR/H/0296/001 BE 291225 LABORATOIRES THEA BE
DICLOABAK 1 mg/ml, oφθαλμικές σταγόνες, διάλυμα
FR/H/0296/001 63497/14-09-2011 LABORATOIRES THEA GR
Dicloabak 1mg/ml Augentropfen
FR/H/0296/001 1-30552 LABORATOIRES THEA AT
DICLOABAK 1mg/ml, colirio en solución
FR/H/0296/001 69475 LABORATOIRES THEA ES
DICLOABAK, 1 mg/ml, krople do oczu, roztwór
FR/H/0296/001 14116 LABORATOIRES THEA PL
Diclobene 140 mg Liečivá náplasť
DE/H/1479/001 29/0426/08-S TEVA B.V SK
Diclo-CT akut 140 mg Schmerzpflaster 140 mg wirkstoffhaltiges Pflaster
not available 62599.00.00 ABZ-PHARMA GMBH DE
DICLOCULAR 0,1% collirio, soluzione
not available 028495012 AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A.
IT
List of nationally authorised medicinal products EMA/379050/2019 Page 6/59
DICLOCULAR 0,1% collirio, soluzione
not available 028495024 AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A.
IT
DICLODENT 0.074%, doseado a 0.74 mg/ml na forma de solução bucal
not available 5697321 LABORATÓRIOS ATRAL, S.A. PT
DICLODENT 0.074%, doseado a 0.74 mg/ml na forma de solução bucal
not available 4881389; LABORATÓRIOS ATRAL, S.A. PT
Diclodolor 140 mg apósitos adhesivos medicamentosos
DE/H/1479/001 70.307 RATIOPHARM ESPAÑA S.A., ES
Diclofenac ”Orifarm”, gel SE/H/1142/001 48080 ORIFARM GENERICS A/S DK
Diclofenac AbZ 30 mg/g Gel
DE/H/5138/001 99263.00.00 ABZ-PHARMA GMBH DE
Diclofenac acis 30 mg/g Gel
AT/H/0710/001/DC 98529.00.00 ACIS ARZNEIMITTEL GMBH DE
Diclofenac Bluepharma 10 mg/g Gel
not available 5565031 BLUEPHARMA GENÉRICOS - COMÉRCIO DE MEDICAMENTOS, S.A.
PT
Diclofenac Dermapharm 3% Gel
AT/H/0710/001 137450 DERMAPHARM AG AT
Diclofenac Dermapharm 3% gel
AT/H/0710/001 BE508426 DERMAPHARM AG BE
List of nationally authorised medicinal products EMA/379050/2019 Page 7/59
Diclofenac Devatis 1 mg/ml Augentropfen im Einzeldosisbehältnis
NL/H/2859/001 89756.00.00 DEVATIS GMBH DE
Diclofenac Devatis 1 mg/ml, oogdruppels, oplosssing, verpakking voor éénmalig gebruik
NL/H/2859/001 RVG 113364 DEVATIS GMBH NL
Diclofenac ELC 0,5 mg/0,5 ml Augentropfen, Lösung im Einzeldosisbehältnis
PT/H/1749/001 98693.00.00 ELC GROUP S.R.O. DE
Diclofenac ELC 0,5 mg/0,5 ml colírio em unidoses, solução
PT/H/1749/001/DC 5757067 ELC GROUP S.R.O. PT
Diclofenac Heumann Gel not available 19199.00.00 HEUMANN PHARMA GMBH & CO. GENERICA KG
DE
Diclofenac Kappler 140 mg wirkstoffhaltiges Pflaster
DE/H/4645/001 96683.00.00 FIDIA FARMACEUTICI S.P.A DE
Diclofenac Na Dermapharm 3% gel
AT/H/0710/001 RVG 120046 DERMAPHARM AG NL
Diclofenac Orifarm 11,6 mg/g gel
SE/H/1142/001 45481 ORIFARM GENERICS A/S SE
Diclofenac Patch EG 140 mg emplâtre médicamenteux
DE/H/4645/001 BE518631 EUROGENERICS N.V./S.A. BE
Diclofenac Patch EG 140 mg emplâtre médicamenteux
DE/H/4645/001 2018060174 EUROGENERICS N.V./S.A. LU
List of nationally authorised medicinal products EMA/379050/2019 Page 8/59
Diclofenac Patch EG 140 mg pleister
DE/H/4645/001 BE518631 EUROGENERICS N.V./S.A. BE
Diclofenac Patch EG 140 mg wirkstoffhaltiges Pflaster
DE/H/4645/001 BE518631 EUROGENERICS N.V./S.A. BE
Diclofenac Pharmakern 23,2 mg/g gel
not available 5752001 PHARMAKERN PORTUGAL – PRODUTOS FARMACÊUTICOS, SOCIEDADE UNIPESSOAL, LDA.
PT
Diclofenac Pharmakern 23,2 mg/g gel
not available 5751979 PHARMAKERN PORTUGAL – PRODUTOS FARMACÊUTICOS, SOCIEDADE UNIPESSOAL, LDA.
PT
Diclofenac Pharmakern 23,2 mg/g gel
not available 5751961 PHARMAKERN PORTUGAL – PRODUTOS FARMACÊUTICOS, SOCIEDADE UNIPESSOAL, LDA.
PT
DICLOFENAC PHARMENTIS 140 mg cerotti medicati
DE/H/1479/001 038752010 FARMAPRO S.R.L. IT
DICLOFENAC PHARMENTIS 140 mg cerotti medicati
DE/H/1479/001 038752022 FARMAPRO S.R.L. IT
DICLOFENAC PHARMENTIS 140 mg cerotti medicati
DE/H/1479/001 038752034 FARMAPRO S.R.L. IT
DICLOFENAC PHARMENTIS 140 mg cerotti medicati
DE/H/1479/001 038752046 FARMAPRO S.R.L. IT
List of nationally authorised medicinal products EMA/379050/2019 Page 9/59
Diclofenac Sandoz 50 mg/g gél
not available OGYI-T-23245/01 SANDOZ HUNGÁRIA KFT HU
Diclofenac Sandoz 50 mg/g gél
not available OGYI-T-23245/02 SANDOZ HUNGÁRIA KFT HU
Diclofenac Terapia 10 mg/g cremă
not available 4097/2011/01 TERAPIA S.A. RO
Diclofenac Terapia 10 mg/g cremă
not available 4097/2011/02 TERAPIA S.A. RO
Diclofenac Terapia 10 mg/g gel
not available 6513/2014/01 TERAPIA S.A. RO
Diclofenac Terapia 50 mg/g gel
not available 4098/2011/02 TERAPIA S.A. RO
Diclofenac Terapia 50 mg/g gel
not available 4098/2011/01 TERAPIA S.A. RO
DICLOFENAC TEVA CONSEIL 1 %, emplâtre médicamenteux
not available NL37788 RATIOPHARM GMBH FR
Diclofenac-Natrium Stragen 10 mg/g Gel
not available 81718.00.00 STRAGEN NORDIC A/S DE
Diclofenac-Natrium Stragen 10 mg/g Gel
not available 2200473.00.00 STRAGEN NORDIC A/S DE
List of nationally authorised medicinal products EMA/379050/2019 Page 10/59
Diclofenaco ABAMED 1 mg/ml colirio en solución en envase unidosis.
not available 77503 ABAMED PHARMA, S.L. ES
Diclofenaco Dermapharm 30 mg/g Gel
AT/H/0710/001 81761 DERMAPHARM AG ES
Diclofenaco Kern Pharma 11,6 mg/g gel
not available 74.119 KERN PHARMA, S.L. ES
DICLOFENACO PENSA 10 mg/g gel
not available 70.538 PENSA PHARMA, S.A.U. ES
DICLOFENACO PHARMAGENUS 10 mg/g gel
not available 73.473 ARISTO PHARMA IBERIA, S.L. ES
Diclofenaco ratiopharm 30 mg/g gel
DE/H/5130/001 83055 RATIOPHARM ESPAÑA S.A. ES
Diclofenaco Teva 30 mg/g gel
DE/H/5138/001 83054 TEVA B.V ES
Diclofenaco-lepori 1 mg/ml colirio en solución
not available 61.812 ANGELINI FARMACEUTICA, S.A.
ES
Diclofenaco-lepori 1 mg/ml colirio en solución en envase unidosis
not available 63.643 ANGELINI FARMACEUTICA, S.A.
ES
Diclofenac-ratiopharm® 30 mg/g Gel
DE/H/5130/001 99197.00.00 RATIOPHARM GMBH DE
List of nationally authorised medicinal products EMA/379050/2019 Page 11/59
Diclofenac-ratiopharm® Schmerzpflaster 140 mg wirkstoffhaltiges Pflaster
DE/H/1479/001 62430.00.00 RATIOPHARM GMBH DE
DICLOFTIL “0,1% collirio, soluzione”
not available 029041011 FARMIGEA SPA IT
Dicloftil 0,1% collirio, soluzione
not available 029041023 FARMIGEA SPA IT
Diclokern 11,6 mg/g gel not available 76209 KERN PHARMA, S.L. ES
DICLOMED 0,3 mg/spruzzo, spray per mucosa orale
not available 032085033 FARMAKA S.R.L. IT
DICLOMED 0,74 mg/ml Collutorio
not available 032085019 FARMAKA S.R.L. IT
Diclo-Mepha Schmerzpflaster 140 mg wirkstoffhaltiges Pflaster
DE/H/1481/001 70741.00.00 TEVA B.V DE
DICLOPLAST not available 30723/03-05-2012 ANGELINI PHARMA HELLAS S.A.
GR
DICLORAL not available 42920/11/3-5-2012 LAVIPHARM HELLAS AE GR
DICLORAL not available 42919/11//3-5-2012 LAVIPHARM HELLAS AE GR
List of nationally authorised medicinal products EMA/379050/2019 Page 12/59
Dicloreum 30 mg/g spumă cutanată
not available 10603/2018/01 ALFASIGMA S.P.A. RO
DICLOREUM ACTIGEL 1 % gel
not available 035450028 ALFASIGMA S.P.A. IT
DICLOREUM ACTIGEL 1 % gel
not available 035450016 ALFASIGMA S.P.A. IT
DICLOREUM ANTINFIAMMATORIO LOCALE 180 mg cerotti medicati
not available 042685026 ALFASIGMA S.P.A. IT
DICLOREUM ANTINFIAMMATORIO LOCALE 180 mg cerotti medicati
not available 042685038 ALFASIGMA S.P.A. IT
DICLOREUM ANTINFIAMMATORIO LOCALE 180 mg cerotti medicati
not available 042685014 ALFASIGMA S.P.A. IT
DICLOREUM ANTINFIAMMATORIO LOCALE 3% Schiuma cutanea, contenitore sotto pressione
not available 042685040 ALFASIGMA S.P.A. IT
Diclo-Vision sine 1 mg/ml Augentropfen, Lösung im Einzeldosisbehältnis
AT/H/0528/001/DC 1-31525 OMNIVISION GMBH AT
Diclo-Vision sine 1 mg/ml Augentropfen, Lösung im Einzeldosisbehältnis
AT/H/0528/001/DC 84680.00.00 OMNIVISION GMBH DE
List of nationally authorised medicinal products EMA/379050/2019 Page 13/59
Diklofenak ABECE 23,2 mg/g gel
not available 55649 EVOLAN PHARMA AB SE
Diklofenak ABECE 23,2 mg/g gel
not available 55649 EVOLAN PHARMA AB SE
Diklofenak Apofri 11,6 mg/g gel
not available 46780 APOFRI AB SE
Diklofenak Apofri 23,2 mg/g gel
not available 55648 APOFRI AB SE
Diklofenakdietylamin Norfri 11,6 mg/g (1,16%) gel.
not available 17-11511 EVOLAN PHARMA AB NO
Diklofenakdietylamin Norfri 23,2 mg/g (2,32 %) gel.
not available 17-11512 EVOLAN PHARMA AB NO
Dolotren 11,6 mg/g gel not available 59.391 FAES FARMA, S.A. ES
DROPFLAM 1 mg/ml collirio, soluzione
not available 040518021 VISUFARMA SPA IT
DROPFLAM 1 mg/ml collirio, soluzione
not available 040518019 VISUFARMA SPA IT
FASTUM ANTIDOLORIFICO 10 mg/g GEL
not available 040657025 A. MENARINI - INDUSTRIE FARMACEUTICHE RIUNITE - S.R.L.
IT
List of nationally authorised medicinal products EMA/379050/2019 Page 14/59
FASTUM ANTIDOLORIFICO 10 mg/g GEL
not available 040657013 A. MENARINI - INDUSTRIE FARMACEUTICHE RIUNITE - S.R.L.
IT
Flalgo 140 mg wirkstoffhaltiges Pflaster
BE/H/0244/001 BE498693 IBSA FARMACEUTICI ITALIA BE
Flalgo 140 mg, léčivá náplast
BE/H/0244/001 29/402/16-C IBSA SLOVAKIA S.R.O. CZ
Flalgo emplâtre médicamenteux 140 mg
BE/H/0244/001 BE498693 IBSA FARMACEUTICI ITALIA BE
Flalgo, 140 mg, pleister BE/H/0244/001 BE498693 IBSA FARMACEUTICI ITALIA BE
Flectopar liečivá náplasť Flectopar 140 mg liečivá náplasť
BE/H/0244/001 29/0392/16-S IBSA SLOVAKIA S.R.O. SK
FLECTOR 1 POUR CENT, gel
not available 34009 333 846 1 6 LABORATOIRES GENEVRIER FR
FLECTOR 1 POUR CENT, gel
not available 34009 333 847 8 4 LABORATOIRES GENEVRIER FR
FLECTOR 1 POUR CENT, gel
not available 34009 333 848 4 5 LABORATOIRES GENEVRIER FR
FLECTOR 1 POUR CENT, gel
not available 34009 377 842 1 4 LABORATOIRES GENEVRIER FR
List of nationally authorised medicinal products EMA/379050/2019 Page 15/59
Flector 1% gel not available 027757020 IBSA FARMACEUTICI ITALIA IT
Flector 10 mg/g gél not available OGYI-T-5033/01 IBSA PHARMA KFT HU
Flector 10 mg/g gél not available OGYI-T-5033/02 IBSA PHARMA KFT HU
Flector 140 mg gyógyszeres tapasz
not available OGYI-T-5033/05 IBSA PHARMA KFT HU
Flector 140 mg gyógyszeres tapasz
not available OGYI-T-5033/06 IBSA PHARMA KFT HU
Flector 140 mg gyógyszeres tapasz
not available OGYI-T-5033/07 IBSA PHARMA KFT HU
Flector 140 mg gyógyszeres tapasz
not available OGYI-T-5033/08 IBSA PHARMA KFT HU
Flector 140 mg gyógyszeres tapasz
not available OGYI-T-5033/09 IBSA PHARMA KFT HU
Flector 140 mg gyógyszeres tapasz
not available OGYI-T-5033/10 IBSA PHARMA KFT HU
Flector 140 mg, medicinskt plåster
FR/H/0225/001 19221 IBSA FARMACEUTICI ITALIA SE
List of nationally authorised medicinal products EMA/379050/2019 Page 16/59
FLECTOR 180 mg cerotto medicato
not available 027757032 IBSA FARMACEUTICI ITALIA IT
FLECTOR 180 mg cerotto medicato
not available 027757069 IBSA FARMACEUTICI ITALIA IT
FLECTOR 180 mg cerotto medicato
not available 027757044 IBSA FARMACEUTICI ITALIA IT
FLECTOR 180 mg cerotto medicato
not available 027757071 IBSA FARMACEUTICI ITALIA IT
Flector EP - Pflaster not available 1-23243 SANOVA PHARMA GESMBH AT
Flector EP 10 mg/g gel not available 29/350/96-C IBSA SLOVAKIA S.R.O. CZ
Flector EP náplasť not available 29/0472/94-S IBSA SLOVAKIA S.R.O. SK
FLECTOR EP TISSUGEL not available 29/361/96-C IBSA SLOVAKIA S.R.O. CZ
Flector Extra 10 mg/g gél not available OGYI-T-5033/11 IBSA PHARMA KFT HU
Flector Extra 10 mg/g gél not available OGYI-T-5033/12 IBSA PHARMA KFT HU
List of nationally authorised medicinal products EMA/379050/2019 Page 17/59
Flector Schmerzpflaster Diclofenac Epolamin 180 mg entsprechend Diclofenac Natrium 140 mg wirkstoffhaltiges Pflaster
FR/H/0267/001 62521.00.00 IBSA FARMACEUTICI ITALIA DE
Flector Tissugel 1 % compresses imprégnées
not available BE208537 THERABEL PHARMA S.A. BE
Flector Tissugel 1 % compresses imprégnées
not available 0748/06038467 THERABEL PHARMA S.A. LU
Flector Tissugel 1 % imprägnierte Verbände
not available BE 208537 THERABEL PHARMA S.A. BE
Flector Tissugel 1 % imprägnierte Verbände
not available 0748/06038467 THERABEL PHARMA S.A. LU
Flector Tissugel 1% geïmpregneerde verbandgazen
not available BE 208537 THERABEL PHARMA S.A. BE
FLECTOR Tissugel 140 mg sistema transdérmico
not available 3231693 LABORATÓRIOS DELTA, S.A. PT
FLECTOR Tissugel 140 mg sistema transdérmico
not available 3231594 LABORATÓRIOS DELTA, S.A. PT
FLECTOR Tissugel 140 mg sistema transdérmico
not available 3231495 LABORATÓRIOS DELTA, S.A. PT
List of nationally authorised medicinal products EMA/379050/2019 Page 18/59
FLECTOR TISSUGEL 140 mg, emplâtre médicamenteux
FR/H/0225/001 34009 339 064 5 0 LABORATOIRES GENEVRIER FR
FLECTOR TISSUGEL 140 mg, emplâtre médicamenteux
FR/H/0225/001 34009 337 830 2 0 LABORATOIRES GENEVRIER FR
FLECTOR TISSUGEL 140 mg, emplâtre médicamenteux
FR/H/0225/001 34009 337 831 9 8 LABORATOIRES GENEVRIER FR
FLECTOR TISSUGEL 140 mg, emplâtre médicamenteux
FR/H/0225/001 34009 337 832 5 9 LABORATOIRES GENEVRIER FR
FLECTOR TISSUGEL 140mg medicated plaster
FR/H/0267/001 PL 21039/0004 IBSA FARMACEUTICI ITALIA UK
Flector Tissugel, 1%, plaster leczniczy (Diclofenacum epolaminum)
FR/H/0225/001 11803 IBSA FARMACEUTICI ITALIA PL
Flector, medicinsk plaster FR/H/0225/001 34600 IBSA FARMACEUTICI ITALIA DK
Flector® EP gél not available 29/0471/94-S IBSA SLOVAKIA S.R.O. SK
Flectorin 140 mg gyógyszeres tapasz
BE/H/0244/001 OGYI-T-23051/01 IBSA PHARMA KFT HU
Flectorin 140 mg gyógyszeres tapasz
BE/H/0244/001 OGYI-T-23051/02 IBSA PHARMA KFT HU
List of nationally authorised medicinal products EMA/379050/2019 Page 19/59
Flectorin 140 mg gyógyszeres tapasz
BE/H/0244/001 OGYI-T-23051/03 IBSA PHARMA KFT HU
Flectorin 140 mg gyógyszeres tapasz
BE/H/0244/001 OGYI-T-23051/04 IBSA PHARMA KFT HU
Flectormed 140 mg cerotto medicato
BE/H/0244/001 044275016 IBSA FARMACEUTICI ITALIA IT
Flectormed 140 mg cerotto medicato
BE/H/0244/001 044275028 IBSA FARMACEUTICI ITALIA IT
Flectormed 140 mg cerotto medicato
BE/H/0244/001 044275042 IBSA FARMACEUTICI ITALIA IT
Flectormed 140 mg cerotto medicato
BE/H/0244/001 044275030 IBSA FARMACEUTICI ITALIA IT
Flectormed 180 mg apósito adhesivo medicamentoso
BE/H/0245/001 82182 IBSA FARMACEUTICI ITALIA ES
GLIMBAX 0,074 g/100 ml ústny výplach
not available 95/0200/04-S ANGELINI PHARMA ÖSTERREICH GMBH
SK
Glimbax, 0,74 mg/ml (0,074%), roztwór do płukania jamy ustnej i gardła
not available 14588 ANGELINI PHARMA POLSKA SP. Z O.O.
PL
GLIMBAX, apă de gură, 0,074 g/100 ml
not available 7416/2006/01 ANGELINI PHARMA ÖSTERREICH GMBH
RO
List of nationally authorised medicinal products EMA/379050/2019 Page 20/59
Holactiv 10 mg/g gel not available 5670716 HOLON S.A. PT
Holactiv 10 mg/g gel not available 5670708 HOLON S.A. PT
Holactiv 10 mg/g gel not available 5670674 HOLON S.A. PT
ITAMI 140 mg liečivá náplasť
DE/H/4645/001 29/0346/17-S FIDIA FARMACEUTICI S.P.A SK
Itami 140 mg ljekoviti naljepak
not available UP/I-530-09/12-01/401 STADA D.O.O. HR
Itami 140 mg medicated plaster
DE/H/4645/001/DC PA0814/002/001 FIDIA FARMACEUTICI S.P.A IE
Itami 140 mg plaster leczniczy
DE/H/2678/001 21301 FIDIA FARMACEUTICI S.P.A PL
Itami 140 mg wirkstoffhaltiges Pflaster
DE/H/4645/001 138228 FIDIA FARMACEUTICI S.P.A AT
Itami 140 mg wirkstoffhaltiges pflaster
DE/H/2677/001 80420.00.00 FIDIA FARMACEUTICI S.P.A DE
Itami 140 mg wirkstoffhaltiges Pflaster
DE/H/2677/001 80420.00.00 FIDIA FARMACEUTICI S.P.A DE
List of nationally authorised medicinal products EMA/379050/2019 Page 21/59
Itami 140 mg wirkstoffhaltiges Pflaster
DE/H/2677/001 80420.00.00 FIDIA FARMACEUTICI S.P.A DE
Itami 140 mg wirkstoffhaltiges pflaster
DE/H/2678/001 80421.00.00 FIDIA FARMACEUTICI S.P.A DE
Itami 140 mg wirkstoffhaltiges Pflaster
DE/H/2678/001 80421.00.00 FIDIA FARMACEUTICI S.P.A DE
Itami 140 mg wirkstoffhaltiges Pflaster
DE/H/2678/001 80421.00.00 FIDIA FARMACEUTICI S.P.A DE
Itami 140 mg zdravilni obliž
DE/H/4645/001 H/18/02423/001-003 FIDIA FARMACEUTICI S.P.A SI
Itami, 140 mg, plaster leczniczy
DE/H/2678/001 21301 FIDIA FARMACEUTICI S.P.A PL
Itami, 140 mg, plaster leczniczy
DE/H/2678/001 21301 FIDIA FARMACEUTICI S.P.A PL
Kinespir Patch 140 mg pleister
DE/H/1479/001 BE322016 TEVA PHARMA BELGIUM N.V./S.A
BE
MOMENLOCALDOL 140 mg cerotti medicati
DE/H/1481/001 038721027 AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A.
IT
MOMENLOCALDOL 140 mg cerotti medicati
DE/H/1481/001 038721015 AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A.
IT
List of nationally authorised medicinal products EMA/379050/2019 Page 22/59
Naclof 1 mg/ml kapi za oko, otopina
not available UP/I-530-09/11-02/320 NOVARTIS HRVATSKA D.O.O. HR
Naclof 1mg/ml kapljice za oko, raztopina
not available 5363-I-1481/12 LABORATOIRES THEA SI
Naclof Unidose, oogdruppels 1 mg/ml
not available RVG 16483 LABORATOIRES THEA NL
Naclof, 1 mg/ml, krople do oczu, roztwór
not available R/1453 LABORATOIRES THEA PL
Naclof, oogdruppels 1 mg/ml
not available RVG 12800 LABORATOIRES THEA NL
Olfen 140 mg Emplastro Medicamentoso
DE/H/1480/001 5128723 MEPHA-INVESTIGACAO DESENVOLVIMENTO E FABRICACAO FARMACEUTICA, LDA.
PT
Olfen 140 mg emplastro medicamentoso
DE/H/1480/001 5128715 MEPHA-INVESTIGACAO DESENVOLVIMENTO E FABRICACAO FARMACEUTICA, LDA.
PT
Olfen 140 mg léčivé náplasti léčivá náplast
DE/H/1479/001 29/509/08-C RATIOPHARM GMBH CZ
Olfen Patch 140 mg plaster leczniczy
DE/H/1480/001 15463 TEVA B.V PL
Olfen Patch 140 mg wirkstoffhaltiges Pflaster
DE/H/1480/001 70740.00.00 TEVA B.V DE
List of nationally authorised medicinal products EMA/379050/2019 Page 23/59
Pennsaid 16 mg/ml Lösung zum Auftragen auf die Haut
UK/H/0442/001 1-24308 DIMETHAID (UK) LIMITED. AT
Pennsaid 16 mg/ml solução cutânea
UK/H/0442/001 4780789 DIMETHAID (UK) LIMITED. PT
Pennsaid 16 mg/ml solução cutânea
UK/H/0442/001 4780888 DIMETHAID (UK) LIMITED. PT
Pennsaid 16 mg/ml solução cutânea
UK/H/0442/001 4780987 DIMETHAID (UK) LIMITED. PT
PENNSAID® 16 mg/ml cutaneous solution
UK/H/0442/001 PL 18329/0001 DIMETHAID (UK) LIMITED. UK
PENNSAID® 16 mg/ml soluzione cutanea
UK/H/0442/001 035719018 DIMETHAID (UK) LIMITED. IT
PENNSAID® 16 mg/ml soluzione cutanea
UK/H/0442/001 035719020 DIMETHAID (UK) LIMITED. IT
PENNSAID® 16 mg/ml soluzione cutanea
UK/H/0442/001 035719032 DIMETHAID (UK) LIMITED. IT
PENNSAID® 16mg/ml δερματικό διάλυμα
UK/H/0442/001 39656/08-04-2019 VIANEX S.A. GR
Pennsaid16 mg/ml húðlausn
UK/H/0442/001 IS/1/03/019/01 DIMETHAID (UK) LIMITED. IS
List of nationally authorised medicinal products EMA/379050/2019 Page 24/59
PENNSAIDÒ 16mg/ml δερματικό διάλυμα
UK/H/0442/001 8819/07-02-2018 VIANEX S.A. GR
QPAIN® 1,5% w/w δερματικό διάλυμα
not available 35346/15/16-03-2017 PHARMAZAC SA GR
Solacutan 3% Gel AT/H/0519/001 136996 DERMAPHARM GMBH AT
Solacutan 3% gel AT/H/0710/001 045242029 MIBE PHARMA ITALIA S.R.L. IT
Solacutan 3% gel AT/H/0710/001 045242043 MIBE PHARMA ITALIA S.R.L. IT
Solacutan 3% gel AT/H/0710/001 045242056 MIBE PHARMA ITALIA S.R.L. IT
Solacutan 3% gel AT/H/0710/001 045242068 MIBE PHARMA ITALIA S.R.L. IT
Solacutan 3% gel AT/H/0710/001 045242070 MIBE PHARMA ITALIA S.R.L. IT
Solacutan 3% gel AT/H/0710/001 045242031 MIBE PHARMA ITALIA S.R.L. IT
Solacutan 3% gel AT/H/0710/001 045242017 MIBE PHARMA ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/379050/2019 Page 25/59
Solacutan 3% gel AT/H/0710/001/DC PL 49452/0001 MIBE PHARMA UK LTD UK
Solacutan 30 mg/g Gel AT/H/0519/001 90764.00.00 DERMAPHARM AG DE
Solacutan 30 mg/g gel AT/H/0519/001 HR-H-614695649 MIBE PHARMACEUTICALS D.O.O.
HR
Solacutan, 30 mg/g, żel AT/H/0519/001 23371 SUN-FARM SP. Z.O.O. PL
Solaraze 3 % geeli DE/H/5854/001 17888 ALMIRALL, S.A. FI
Solaraze 3 % gel diklofenaknatrium
DE/H/5854/001 17888 ALMIRALL, S.A. FI
SOLARAZE 3 %, gel DE/H/5854/001 34009 349 080 3 3 ALMIRALL, S.A. FR
SOLARAZE 3 %, gel DE/H/5854/001 34009 349 082 6 2 ALMIRALL, S.A. FR
SOLARAZE 3 %, gel DE/H/5854/001 34009 387 108 9 2 ALMIRALL, S.A. FR
SOLARAZE 3 %, gel DE/H/5854/001 34009 387 110 3 5 ALMIRALL, S.A. FR
List of nationally authorised medicinal products EMA/379050/2019 Page 26/59
SOLARAZE 3 %, gel DE/H/5854/001 34009 387 112 6 4 ALMIRALL, S.A. FR
Solaraze 3 %, gel DE/H/5854/001 02-1566 ALMIRALL, S.A. NO
Solaraze 3% Gel DE/H/5854/001 1-24961 ALMIRALL, S.A. AT
Solaraze 3% Gel DE/H/5854/001 42752.00.00 ALMIRALL, S.A. DE
Solaraze 3% gel DE/H/5854/001 034129027 ALMIRALL, S.A. IT
Solaraze 3% gel DE/H/5854/001 034129054 ALMIRALL, S.A. IT
Solaraze 3% gel DE/H/5854/001 034129041 ALMIRALL, S.A. IT
Solaraze 3% gel DE/H/5854/001 034129015 ALMIRALL, S.A. IT
Solaraze 3% gel DE/H/5854/001 034129039 ALMIRALL, S.A. IT
Solaraze 3% Gel DE/H/5854/001 2003070004 ALMIRALL, S.A. LU
List of nationally authorised medicinal products EMA/379050/2019 Page 27/59
Solaraze 3%, gel DE/H/5854/001 PA0968/004/001 ALMIRALL, S.A. IE
Solaraze 3%, gel DE/H/5854/001 14192 ALMIRALL, S.A. SE
Solaraze 30 mg/g Gel DE/H/5854/001 73.714 ALMIRALL, S.A. ES
Solaraze gel a 3% DE/H/5854/001 4392486 ALMIRALL, S.A. PT
Solaraze gel a 3% DE/H/5854/001 5184254 ALMIRALL, S.A. PT
Solaraze gel a 3% DE/H/5854/001 5184262 ALMIRALL, S.A. PT
Solaraze gel a 3% DE/H/5854/001 5184247 ALMIRALL, S.A. PT
Solaraze gel a 3% DE/H/5854/001 4392387 ALMIRALL, S.A. PT
Solaraze, gel DE/H/5854/001 34524 ALMIRALL, S.A. DK
Solaraze® 3%, γέλη DE/H/5854/001 75279 / 24-10-2012 ALMIRALL, S.A. GR
List of nationally authorised medicinal products EMA/379050/2019 Page 28/59
Solaraze™ 3% gel DE/H/5854/001 PL 16973/0012 ALMIRALL, S.A. UK
Solaraze™ 3%, hlaup DE/H/5854/001 IS/1/03/009/01 ALMIRALL, S.A. IS
SPRAYMIK 4% cutaneous spray
UK/H/1221/001 PL 18017/0008 MIKA PHARMA GMBH UK
Voltabak, øjendråber, opløsning
FR/H/0296/001 47537 LABORATOIRES THEA DK
Voltadol 11,6 mg/g Gel not available 71.620 GLAXOSMITHKLINE CONSUMER HEALTHCARE, S.A.
ES
VOLTADOL 140mg, Εμπλαστρο
DE/H/2679/001 300500102 GLAXOSMITHKLINE CONSUMER HEALTHCARE HELLAS SA
GR
VOLTADOL 140mg, Εμπλαστρο
DE/H/2679/001 300500101 GLAXOSMITHKLINE CONSUMER HEALTHCARE HELLAS SA
GR
VOLTADOL 140mg, Εμπλαστρο
DE/H/2679/001 300500103 GLAXOSMITHKLINE CONSUMER HEALTHCARE HELLAS SA
GR
Voltadol Forte 23,2 mg/g gel.
not available 78407 GLAXOSMITHKLINE CONSUMER HEALTHCARE, S.A.
ES
Voltadol Forte Schmerzgel not available 1-31531 GSK-GEBRO CONSUMER HEALTHCARE GMBH
AT
List of nationally authorised medicinal products EMA/379050/2019 Page 29/59
Voltadol Schmerzgel not available 1-23820 GSK-GEBRO CONSUMER HEALTHCARE GMBH
AT
Voltaren not available 46325 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
DK
Voltaren not available 35874 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
DK
Voltaren DE/H/2679/001 814113 GLAXOSMITHKLINE DUNGARVAN LIMITED
EE
Voltaren ® Emulgel - Gel not available 1-18355 NOVARTIS PHARMA GMBH AT
Voltaren ® Emulgel - Gel not available 1-18355 NOVARTIS PHARMA GMBH AT
Voltaren ® Emulgel - Gel not available 1-18355 NOVARTIS PHARMA GMBH AT
Voltarén 1 mg/ml colirio en solución
not available 58.308 LABORATOIRES THEA ES
Voltarén 1 mg/ml colirio en solución en envases unidosis
not available 62.326 LABORATOIRES THEA ES
Voltaren 11,6 mg/g gel. not available 20227 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
SE
List of nationally authorised medicinal products EMA/379050/2019 Page 30/59
Voltaren 11,6 mg/g hlaup not available IS/1/04/156/01 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
IS
Voltaren 140 mg lääkelaastari
DE/H/2679/001 30251 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
FI
VOLTAREN 140 MG LÉČIVÁ NÁPLAST
DE/H/2679/001 29/257/13-C GLAXOSMITHKLINE CONSUMER HEALTHCARE CZECH REPUBLIC S.R.O.
CZ
Voltaren 140 mg liečivá náplasť
DE/H/2679/001 29/0131/13-S GLAXOSMITHKLINE CONSUMER HEALTHCARE CZECH REPUBLIC S.R.O.
SK
Voltaren 140 mg medicinskt plåster
DE/H/2679/001 47014 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
SE
Voltaren 23,2 mg/g gel not available 44669 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
SE
VOLTAREN ACTIGO 140 MG GYÓGYSZERES TAPASZ
DE/H/2679/001 OGYI-T-22466/02 GLAXOSMITHKLINE-CONSUMER KFT.
HU
VOLTAREN ACTIGO 140 MG GYÓGYSZERES TAPASZ
DE/H/2679/001 OGYI-T-22466/03 GLAXOSMITHKLINE-CONSUMER KFT.
HU
VOLTAREN ACTIGO 140 MG GYÓGYSZERES TAPASZ
DE/H/2679/001 OGYI-T-22466/01 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Voltaren Aktigo 140 mg ārstnieciskais plāksteris
DE/H/2679/001 13-0111 GLAXOSMITHKLINE DUNGARVAN LIMITED
LV
List of nationally authorised medicinal products EMA/379050/2019 Page 31/59
Voltaren Aktigo 140 mg vaistinis pleistras
DE/H/2679/001 LT/1/13/3467/002 GLAXOSMITHKLINE DUNGARVAN LIMITED
LT
Voltaren Colírio Unidoses, 0,3 mg/0,3 ml, Colírio, solução
not available 2911287 LABORATOIRES THEA PT
Voltaren Colírio Unidoses, 0,3 mg/0,3 ml, Colírio, solução
not available 2911386 LABORATOIRES THEA PT
Voltaren Colírio Unidoses, 0,3 mg/0,3 ml, Colírio, solução
not available 2911485 LABORATOIRES THEA PT
Voltaren Emulgel not available 18989 GLAXOSMITHKLINE CONSUMER HEALTHCARE HELLAS SA
CY
Voltaren Emulgel not available MA1177/00401 GLAXOSMITHKLINE CONSUMER HEALTHCARE HELLAS SA
MT
VOLTAREN EMULGEL 1% not available R/1735 GLAXOSMITHKLINE CONSUMER HEALTHCARE SP. Z O.O.
PL
VOLTAREN EMULGEL 1% gel
not available BE135317 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
VOLTAREN EMULGEL 1% gel
not available BE274574 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
VOLTAREN EMULGEL 1% gel
not available BE294847 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
List of nationally authorised medicinal products EMA/379050/2019 Page 32/59
VOLTAREN Emulgel 1% gel
not available 034548091 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 1% gel
not available 034548103 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 1% gel
not available 034548115 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 1% gel
not available 034548038 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 1% gel
not available 034548040 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 1% gel
not available 034548089 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 1% gel
not available 034548139 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 1% gel
not available 034548091 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 1% gel
not available 034548103 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 1% gel
not available 034548115 NOVARTIS FARMA S.P.A. IT
List of nationally authorised medicinal products EMA/379050/2019 Page 33/59
VOLTAREN Emulgel 1% gel
not available 034548038 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 1% gel
not available 034548040 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 1% gel
not available 034548089 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 1% gel
not available 034548139 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 1% gel
not available 034548091 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 1% gel
not available 034548103 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 1% gel
not available 034548115 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 1% gel
not available 034548038 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 1% gel
not available 034548040 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 1% gel
not available 034548089 NOVARTIS FARMA S.P.A. IT
List of nationally authorised medicinal products EMA/379050/2019 Page 34/59
VOLTAREN Emulgel 1% gel
not available 034548139 NOVARTIS FARMA S.P.A. IT
Voltaren Emulgel 1% gél not available OGYI-T-5572/19 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Voltaren Emulgel 1% gél not available OGYI-T-5572/20 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Voltaren Emulgel 1% gél not available OGYI-T-5572/18 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Voltaren Emulgel 1% gél not available OGYI-T-5572/13 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Voltaren Emulgel 1% gél not available OGYI-T-5572/10 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Voltaren Emulgel 1% gél not available OGYI-T-5572/17 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Voltaren Emulgel 1% gél not available OGYI-T-5572/16 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Voltaren Emulgel 1% gél not available OGYI-T-5572/14 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Voltaren Emulgel 1% gél not available OGYI-T-5572/12 GLAXOSMITHKLINE-CONSUMER KFT.
HU
List of nationally authorised medicinal products EMA/379050/2019 Page 35/59
Voltaren Emulgel 1% gél not available OGYI-T-5572/15 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Voltaren Emulgel 1% gél not available OGYI-T-5572/11 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Voltaren Emulgel 1% gél not available OGYI-T-5572/32 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Voltaren Emulgel 1% gél not available OGYI-T-5572/45 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Voltaren Emulgel 1% gél not available OGYI-T-5572/44 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Voltaren Emulgel 1% gél not available OGYI-T-5572/46 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Voltaren Emulgel 1% gél not available OGYI-T-5572/47 GLAXOSMITHKLINE-CONSUMER KFT.
HU
VOLTAREN EMULGEL 1% gel PRD388830
not available BE274574 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
VOLTAREN EMULGEL 1% gel PRD393555
not available BE294847 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
VOLTAREN EMULGEL 1% gel PRD393558
not available BE135317 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
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VOLTAREN EMULGEL 1%, Gel
not available BE294847 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
VOLTAREN EMULGEL 1%, Gel
not available BE135317 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
VOLTAREN EMULGEL 1%, Gel
not available BE274574 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
Voltaren Emulgel 1,16 % Gel
not available 520.00.03 GLAXOSMITHKLINE CONSUMER HEALTHCARE GMBH & CO. KG
DE
VOLTAREN EMULGEL 1.16%, GEL
not available RVG 31377 GLAXOSMITHKLINE CONSUMER HEALTHCARE B.V
NL
Voltaren Emulgel 10 mg/g gel
not available 29/127/88-C GLAXOSMITHKLINE CONSUMER HEALTHCARE CZECH REPUBLIC S.R.O.
CZ
Voltaren Emulgel 10 mg/g gel
not available HR-H-727399086 GLAXOSMITHKLINE DUNGARVAN LIMITED
HR
Voltaren Emulgel 11,6 mg/g (1,16%) geel
not available 061794 GLAXOSMITHKLINE DUNGARVAN LIMITED
EE
VOLTAREN EMULGEL 11,6 mg/g geeli
not available 11748 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
FI
VOLTAREN EMULGEL 11,6 mg/g geeli
not available 11748 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
FI
List of nationally authorised medicinal products EMA/379050/2019 Page 37/59
VOLTAREN EMULGEL 11,6 mg/g gel
not available 5428/2005/04 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L.
RO
VOLTAREN EMULGEL 11,6 mg/g gel
not available 5428/2005/03 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L.
RO
VOLTAREN EMULGEL 11,6 mg/g gel
not available 5428/2005/07 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L.
RO
VOLTAREN EMULGEL 11,6 mg/g gel
not available 5428/2005/05 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L.
RO
VOLTAREN EMULGEL 11,6 mg/g gel
not available 5428/2005/06 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L.
RO
VOLTAREN EMULGEL 11,6 mg/g gel
not available 5428/2005/02 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L.
RO
VOLTAREN EMULGEL 11,6 mg/g gel
not available 5428/2005/09 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L.
RO
VOLTAREN EMULGEL 11,6 mg/g gel
not available 5428/2005/08 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L.
RO
VOLTAREN EMULGEL 11,6 mg/g gel
not available 5428/2005/01 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L.
RO
Voltaren Emulgel 11,6 mg/g gel
not available 5428/2005/10 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L.
RO
List of nationally authorised medicinal products EMA/379050/2019 Page 38/59
Voltaren Emulgel 11,6 mg/g gel
not available 5428/2005/11 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L.
RO
Voltaren Emulgel 11,6 mg/g gel
not available H/92/01655/003 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
SI
Voltaren Emulgel 11,6 mg/g gel
not available H/92/01655/002 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
SI
Voltaren Emulgel 11,6 mg/g gel
not available H/92/01655/005 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
SI
Voltaren Emulgel 11,6 mg/g gel
not available H/92/01655/004 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
SI
Voltaren Emulgel 11,6 mg/g gel
not available H/92/01655/001 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
SI
Voltaren Emulgel 11,6 mg/g gél
not available 29/0127/88-C/S GLAXOSMITHKLINE CONSUMER HEALTHCARE CZECH REPUBLIC S.R.O.
SK
Voltaren Emulgel 11,6 mg/g gel, tlačni vsebnik
not available H/92/01655/006 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
SI
Voltaren Emulgel 11,6 mg/g gelis
not available LT/1/94/0943/004 GLAXOSMITHKLINE DUNGARVAN LIMITED
LT
Voltaren Emulgel 11,6 mg/g gelis
not available LT/1/94/0943/003 GLAXOSMITHKLINE DUNGARVAN LIMITED
LT
List of nationally authorised medicinal products EMA/379050/2019 Page 39/59
Voltaren Emulgel 11,6 mg/g gelis
not available LT/1/94/0943/005 GLAXOSMITHKLINE DUNGARVAN LIMITED
LT
Voltaren Emulgel 11,6 mg/g gelis
not available LT/1/94/0943/012 GLAXOSMITHKLINE DUNGARVAN LIMITED
LT
Voltaren Emulgel 11,6 mg/g gelis
not available LT/1/94/0943/001 GLAXOSMITHKLINE DUNGARVAN LIMITED
LT
Voltaren Emulgel 11,6 mg/g gelis
not available LT/1/94/0943/002 GLAXOSMITHKLINE DUNGARVAN LIMITED
LT
Voltaren Emulgel 11,6 mg/g gelis
not available LT/1/94/0943/006 GLAXOSMITHKLINE DUNGARVAN LIMITED
LT
Voltaren Emulgel 11,6 mg/g gels
not available 94-0179 GLAXOSMITHKLINE DUNGARVAN LIMITED
LV
VOLTAREN Emulgel 2% gel
not available 034548127 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 2% gel
not available 034548053 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 2% gel
not available 034548065 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 2% gel
not available 034548077 NOVARTIS FARMA S.P.A. IT
List of nationally authorised medicinal products EMA/379050/2019 Page 40/59
VOLTAREN Emulgel 2% gel
not available 034548127 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 2% gel
not available 034548053 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 2% gel
not available 034548065 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 2% gel
not available 034548077 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 2% gel
not available 034548127 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 2% gel
not available 034548053 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 2% gel
not available 034548065 NOVARTIS FARMA S.P.A. IT
VOLTAREN Emulgel 2% gel
not available 034548077 NOVARTIS FARMA S.P.A. IT
Voltaren Emulgel 20 mg/g gel
not available HR-H-828714474 GLAXOSMITHKLINE DUNGARVAN LIMITED
HR
Voltaren Emulgel 23,2 mg/g (2,32%) geel
not available 810513 GLAXOSMITHKLINE DUNGARVAN LIMITED
EE
List of nationally authorised medicinal products EMA/379050/2019 Page 41/59
Voltaren Emulgel 23,2 mg/g gel
not available H/92/01655/008 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
SI
Voltaren Emulgel 23,2 mg/g gel
not available H/92/01655/007 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
SI
Voltaren Emulgel 23,2 mg/g gelis
not available LT/1/94/0943/010 GLAXOSMITHKLINE DUNGARVAN LIMITED
LT
Voltaren Emulgel 23,2 mg/g gelis
not available LT/1/94/0943/011 GLAXOSMITHKLINE DUNGARVAN LIMITED
LT
Voltaren Emulgel 23,2 mg/g gelis
not available LT/1/94/0943/013 GLAXOSMITHKLINE DUNGARVAN LIMITED
LT
Voltaren Emulgel 23,2 mg/g gelis
not available LT/1/94/0943/008 GLAXOSMITHKLINE DUNGARVAN LIMITED
LT
Voltaren Emulgel 23,2 mg/g gelis
not available LT/1/94/0943/007 GLAXOSMITHKLINE DUNGARVAN LIMITED
LT
Voltaren Emulgel 23,2 mg/g gelis
not available LT/1/94/0943/009 GLAXOSMITHKLINE DUNGARVAN LIMITED
LT
Voltaren Emulgel 23,2 mg/g gels
not available 12-0188 GLAXOSMITHKLINE DUNGARVAN LIMITED
LV
VOLTAREN EMULGEL Forte 2% gel
not available BE440422 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
List of nationally authorised medicinal products EMA/379050/2019 Page 42/59
VOLTAREN EMULGEL Forte 2% Gel PRD1761304
not available BE440422 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
VOLTAREN EMULGEL Forte 2% gel PRD1763815
not available BE440422 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
Voltaren Emulgel Forte 20 mg/g gél
not available OGYI-T-5572/37 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Voltaren Emulgel Forte 20 mg/g gél
not available OGYI-T-5572/34 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Voltaren Emulgel Forte 20 mg/g gél
not available OGYI-T-5572/35 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Voltaren Emulgel Forte 20 mg/g gél
not available OGYI-T-5572/42 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Voltaren Emulgel Forte 20 mg/g gél
not available OGYI-T-5572/33 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Voltaren Emulgel Forte 20 mg/g gél
not available OGYI-T-5572/39 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Voltaren Emulgel Forte 20 mg/g gél
not available OGYI-T-5572/38 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Voltaren Emulgel Forte 20 mg/g gél
not available OGYI-T-5572/36 GLAXOSMITHKLINE-CONSUMER KFT.
HU
List of nationally authorised medicinal products EMA/379050/2019 Page 43/59
Voltaren Emulgel Forte 20 mg/g gél
not available OGYI-T-5572/41 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Voltaren Emulgel Forte 20 mg/g gél
not available OGYI-T-5572/40 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Voltaren Emulgel Forte 20 mg/g gél
not available OGYI-T-5572/43 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Voltaren Emulgelex 23,2 mg/g gel
not available 5490602 GLAXOSMITHKLINE CONSUMER HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA
PT
Voltaren Emulgelex 23,2 mg/g gel
not available 5625025 GLAXOSMITHKLINE CONSUMER HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA
PT
Voltaren Emulgelex 23,2 mg/g gel
not available 5374848 GLAXOSMITHKLINE CONSUMER HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA
PT
Voltaren Emulgelex 23,2 mg/g gel
not available 5380571 GLAXOSMITHKLINE CONSUMER HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA
PT
Voltaren Emulgelex 23,2 mg/g gel
not available 5380563 GLAXOSMITHKLINE CONSUMER HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA
PT
Voltaren Emulgelex 23,2 mg/g gel PRD1764141
not available 5380571 GLAXOSMITHKLINE CONSUMER HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA
PT
List of nationally authorised medicinal products EMA/379050/2019 Page 44/59
Voltaren Emulgelex 23,2 mg/g gel PRD1798855
not available 5490602 GLAXOSMITHKLINE CONSUMER HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA
PT
VOLTAREN FORTE not available 122881001 NOVARTIS (HELLAS) S.A.C.I. GR
VOLTAREN FORTE not available 122881002 NOVARTIS (HELLAS) S.A.C.I. GR
VOLTAREN FORTE not available 122881003 NOVARTIS (HELLAS) S.A.C.I. GR
VOLTAREN FORTE not available 122821004 NOVARTIS (HELLAS) S.A.C.I. GR
VOLTAREN FORTE not available 122881001 NOVARTIS (HELLAS) S.A.C.I. GR
VOLTAREN FORTE not available 122881002 NOVARTIS (HELLAS) S.A.C.I. GR
VOLTAREN FORTE not available 122881003 NOVARTIS (HELLAS) S.A.C.I. GR
VOLTAREN FORTE not available 122821004 NOVARTIS (HELLAS) S.A.C.I. GR
Voltaren Forte 2.32% gel not available MA1177/00402 GLAXOSMITHKLINE CONSUMER HEALTHCARE HELLAS SA
MT
List of nationally authorised medicinal products EMA/379050/2019 Page 45/59
Voltaren Forte 2.32% gel not available MA1177/00402 GLAXOSMITHKLINE CONSUMER HEALTHCARE HELLAS SA
MT
Voltaren Forte 2.32% gel not available MA1177/00402 GLAXOSMITHKLINE CONSUMER HEALTHCARE HELLAS SA
MT
Voltaren Forte 2,32 % gél not available 29/0481/11-S GLAXOSMITHKLINE CONSUMER HEALTHCARE CZECH REPUBLIC S.R.O.
SK
Voltaren Forte 23,2 mg/g geeli
not available 28882 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
FI
Voltaren Forte 23,2 mg/g geeli
not available 28882 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
FI
Voltaren Forte 23,2 mg/g gel
not available 7270/2014/02 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L.
RO
Voltaren Forte 23,2 mg/g gel
not available 7270/2014/04 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L.
RO
Voltaren Forte 23,2 mg/g gel
not available 7270/2014/01 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L.
RO
Voltaren Forte 23,2 mg/g gel
not available 7270/2014/03 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L.
RO
Voltaren Forte 23,2 mg/g gel
not available 7270/2014/08 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L.
RO
List of nationally authorised medicinal products EMA/379050/2019 Page 46/59
Voltaren Forte 23,2 mg/g gel
not available 7270/2014/07 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L.
RO
Voltaren Forte 23,2 mg/g gel
not available 7270/2014/09 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L.
RO
Voltaren Forte 23,2 mg/g gel
not available 7270/2014/05 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L.
RO
Voltaren Forte 23,2 mg/g gel
not available 7270/2014/06 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L.
RO
Voltaren MAX, 23,2 mg/g, żel
not available 20030 GLAXOSMITHKLINE CONSUMER HEALTHCARE SP. Z O.O.
PL
Voltaren Ofta 0,1% collirio, soluzione
not available A.I.C. 027917018 LABORATOIRES THEA IT
Voltaren Ofta 0,1% collirio, soluzione
not available A.I.C. N. 027917020 LABORATOIRES THEA IT
Voltaren Ofta 0,1% collirio, soluzione
not available A.I.C. N. 027917032 LABORATOIRES THEA IT
VOLTAREN OFTABAK 1 mg/ml collirio, soluzione
FR/H/0296/001 037696010/M LABORATOIRES THEA IT
Voltaren Ophtha – 1 mg/ml Augentropfen
not available 1–19877 LABORATOIRES THEA AT
List of nationally authorised medicinal products EMA/379050/2019 Page 47/59
Voltaren Ophtha – 1 mg/ml Einmalaugentropfen
not available 1–23917 LABORATOIRES THEA AT
Voltaren Ophtha 1 mg/ml ögondroppar, lösning
not available 11451 LABORATOIRES THEA SE
Voltaren Ophtha 1 mg/ml ögondroppar, lösning, endosbehållare
not available 12085 LABORATOIRES THEA SE
Voltaren Ophtha 1 mg/ml øyedråper, oppløsning i endosebeholdere.
not available 11-8492 LABORATOIRES THEA NO
Voltaren Ophtha 1 mg/ml øyedråper, oppløsning.
not available 7379 LABORATOIRES THEA NO
Voltaren Ophtha 1 mg/ml silmätipat, liuos
not available 10888 LABORATOIRES THEA FI
Voltaren Ophtha 1 mg/ml silmätipat, liuos kerta-annospakkauksessa
not available 11439 LABORATOIRES THEA FI
Voltaren Ophtha Abak 1 mg/ml, øyedråper, oppløsning
FR/H/0296/001 10-7850 LABORATOIRES THEA NO
Voltaren Ophtha CD 1 mg/ml oldatos szemcsepp
not available OGYI-T-5572/07 LABORATOIRES THEA HU
VOLTAREN OPHTHA CD Ocní kapky, roztok
not available 64/320/91-C LABORATOIRES THEA CZ
List of nationally authorised medicinal products EMA/379050/2019 Page 48/59
Voltaren Ophtha CD, picaturi oftalmice, solutie, 1mg/ml
not available 3246/2003/01 LABORATOIRES THEA RO
Voltaren Patch 140 mg emplâtre médicamenteux
DE/H/2679/001 BE439652 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
Voltaren Patch 140 mg pleister
DE/H/2679/001 BE439652 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
Voltaren Patch 140 mg wirkstoffhaltige Pflaster
DE/H/2679/001 BE439652 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
Voltaren Plast 140 mg emplastro medicamentoso
DE/H/2679/001 5569728 GLAXOSMITHKLINE CONSUMER HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA
PT
Voltaren Plast 140 mg emplastro medicamentoso
DE/H/2679/001 5569744 GLAXOSMITHKLINE CONSUMER HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA
PT
Voltaren Plast 140 mg emplastro medicamentoso
DE/H/2679/001 5569736 GLAXOSMITHKLINE CONSUMER HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA
PT
Voltaren Schmerzgel 11,6 mg/g Gel
not available 87009.00.00 GLAXOSMITHKLINE CONSUMER HEALTHCARE GMBH & CO. KG
DE
Voltaren Schmerzgel 11,6 mg/g Gel
not available 9165.00.00 GLAXOSMITHKLINE CONSUMER HEALTHCARE GMBH & CO. KG
DE
List of nationally authorised medicinal products EMA/379050/2019 Page 49/59
Voltaren Schmerzgel forte 23,2 mg/g Gel
not available 82680.00.00 GLAXOSMITHKLINE CONSUMER HEALTHCARE GMBH & CO. KG
DE
Voltaren Schmerzpflaster 140 mg wirkstoffhaltiges Pflaster
DE/H/2679/001 80422.00.00 GLAXOSMITHKLINE CONSUMER HEALTHCARE GMBH & CO. KG
DE
Voltaren Spray 4% Spray zur Anwendung auf der Haut, Lösung Diclofenac Natrium
not available 82116.00.00 GLAXOSMITHKLINE CONSUMER HEALTHCARE GMBH & CO. KG
DE
VOLTAREN δερματικό εκνέφωμα διάλυμα 4% (w/w)
not available 122881102 NOVARTIS (HELLAS) S.A.C.I. GR
VOLTAREN δερματικό εκνέφωμα διάλυμα 4% (w/w)
not available 122881101 NOVARTIS (HELLAS) S.A.C.I. GR
VOLTAREN δερματικό εκνέφωμα διάλυμα 4% (w/w)
not available 122881102 NOVARTIS (HELLAS) S.A.C.I. GR
VOLTAREN δερματικό εκνέφωμα διάλυμα 4% (w/w)
not available 122881101 NOVARTIS (HELLAS) S.A.C.I. GR
Voltaren, 1 mg/ml Colírio, solução
not available 2223485 LABORATOIRES THEA PT
Voltaren® Emulgel® not available 122880704 NOVARTIS (HELLAS) S.A.C.I. GR
Voltaren® Emulgel® not available 122880701 NOVARTIS (HELLAS) S.A.C.I. GR
List of nationally authorised medicinal products EMA/379050/2019 Page 50/59
Voltaren® Emulgel® not available 122880702 NOVARTIS (HELLAS) S.A.C.I. GR
Voltaren® Emulgel® not available 122880705 NOVARTIS (HELLAS) S.A.C.I. GR
Voltaren® Emulgel® not available 122880706 NOVARTIS (HELLAS) S.A.C.I. GR
Voltaren® Emulgel® not available 122880703 NOVARTIS (HELLAS) S.A.C.I. GR
Voltaren® Emulgel® not available 122880707 NOVARTIS (HELLAS) S.A.C.I. GR
Voltaren® Emulgel® not available 122880708 NOVARTIS (HELLAS) S.A.C.I. GR
Voltaren® Emulgel® not available 122880709 NOVARTIS (HELLAS) S.A.C.I. GR
Voltaren® Emulgel® not available 122880704 NOVARTIS (HELLAS) S.A.C.I. GR
Voltaren® Emulgel® not available 122880701 NOVARTIS (HELLAS) S.A.C.I. GR
Voltaren® Emulgel® not available 122880702 NOVARTIS (HELLAS) S.A.C.I. GR
List of nationally authorised medicinal products EMA/379050/2019 Page 51/59
Voltaren® Emulgel® not available 122880705 NOVARTIS (HELLAS) S.A.C.I. GR
Voltaren® Emulgel® not available 122880706 NOVARTIS (HELLAS) S.A.C.I. GR
Voltaren® Emulgel® not available 122880703 NOVARTIS (HELLAS) S.A.C.I. GR
Voltaren® Emulgel® not available 122880707 NOVARTIS (HELLAS) S.A.C.I. GR
Voltaren® Emulgel® not available 122880704 NOVARTIS (HELLAS) S.A.C.I. GR
Voltaren® Emulgel® not available 122880701 NOVARTIS (HELLAS) S.A.C.I. GR
Voltaren® Emulgel® not available 122880702 NOVARTIS (HELLAS) S.A.C.I. GR
Voltaren® Emulgel® not available 122880705 NOVARTIS (HELLAS) S.A.C.I. GR
Voltaren® Emulgel® not available 122880706 NOVARTIS (HELLAS) S.A.C.I. GR
Voltaren® Emulgel® not available 122880703 NOVARTIS (HELLAS) S.A.C.I. GR
List of nationally authorised medicinal products EMA/379050/2019 Page 52/59
Voltaren® Emulgel® not available 122880707 NOVARTIS (HELLAS) S.A.C.I. GR
Voltarén® Emulgel® not available 58.402 NOVARTIS FARMACÉUTICA S.A.
ES
Voltarén® Emulgel® not available 58.402 NOVARTIS FARMACÉUTICA S.A.
ES
Voltaren® Forte not available 122881005 NOVARTIS (HELLAS) S.A.C.I. GR
Voltaren® Forte not available 122881005 NOVARTIS (HELLAS) S.A.C.I. GR
Voltaren® ophtha 1 mg/ml Augentropfen
not available 11202.00.00 LABORATOIRES THEA DE
Voltaren® Ophtha Eye Drops 0.1%
not available 13462 LABORATOIRES THEA CY
Voltaren® ophtha sine 1 mg/ml Augentropfen
not available 26204.00.00 LABORATOIRES THEA DE
Voltaren® ophtha sine 1 mg/ml Augentropfen
not available 1536/11041074 LABORATOIRES THEA LU
Voltaren140 mg medicinskt plåster
DE/H/2679/001 30251 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
FI
List of nationally authorised medicinal products EMA/379050/2019 Page 53/59
VOLTARENACTIGO 1 POUR CENT, gel
not available 34009 340 765 3 4 GLAXOSMITHKLINE SANTÉ GRAND PUBLIC, RUEIL-MALMAISON
FR
VOLTARENACTIGO 1 POUR CENT, gel
not available 34009 372 302 9 2 GLAXOSMITHKLINE SANTÉ GRAND PUBLIC, RUEIL-MALMAISON
FR
VOLTARENACTIGO 1 POUR CENT, gel
not available 34009 372 303 5 3 GLAXOSMITHKLINE SANTÉ GRAND PUBLIC, RUEIL-MALMAISON
FR
VOLTARENACTIGO 1 POUR CENT, gel
not available 34009 375 463 3 1 GLAXOSMITHKLINE SANTÉ GRAND PUBLIC, RUEIL-MALMAISON
FR
VOLTARENACTIGO 1 POUR CENT, gel
not available 34009 363 540 8 1 GLAXOSMITHKLINE SANTÉ GRAND PUBLIC, RUEIL-MALMAISON
FR
VOLTARENACTIGO 1 POUR CENT, gel
not available 34009 375 465 6 0 GLAXOSMITHKLINE SANTÉ GRAND PUBLIC, RUEIL-MALMAISON
FR
VOLTARENACTIGO 1 POUR CENT, gel
not available 34009 280 077 9 7 GLAXOSMITHKLINE SANTÉ GRAND PUBLIC, RUEIL-MALMAISON
FR
VOLTARENACTIGO 1 POUR CENT, gel
not available 34009 280 078 5 8 GLAXOSMITHKLINE SANTÉ GRAND PUBLIC, RUEIL-MALMAISON
FR
VOLTARENACTIGO 1 POUR CENT, gel
not available 34009 301 289 7 8 GLAXOSMITHKLINE SANTÉ GRAND PUBLIC, RUEIL-MALMAISON
FR
VOLTARENACTIGO 1 POUR CENT, gel
not available 34009 301 480 5 1 GLAXOSMITHKLINE SANTÉ GRAND PUBLIC, RUEIL-MALMAISON
FR
List of nationally authorised medicinal products EMA/379050/2019 Page 54/59
VoltarenActigo 1% Gel en flacon pressurisé
not available 34009 280 079 1 9 GLAXOSMITHKLINE SANTÉ GRAND PUBLIC, RUEIL-MALMAISON
FR
VOLTARENACTIGO 1%, gel en flacon pressurisé
not available 359 314-7 OU 34009 359 314 7 4 GLAXOSMITHKLINE SANTÉ GRAND PUBLIC, RUEIL-MALMAISON
FR
VOLTARENACTIGO 2 % INTENSE, gel
not available 274 075-8 GLAXOSMITHKLINE SANTÉ GRAND PUBLIC, RUEIL-MALMAISON
FR
VOLTARENE EMULGEL 1 %, gel en flacon pressurisé
not available 358 947-6 GLAXOSMITHKLINE SANTÉ GRAND PUBLIC, RUEIL-MALMAISON
FR
VOLTARENE EMULGEL 1 %, gel en flacon pressurisé
not available 358 945-3 GLAXOSMITHKLINE SANTÉ GRAND PUBLIC, RUEIL-MALMAISON
FR
VOLTARENE EMULGEL 1 %, gel en flacon pressurisé
not available 358 951-3 GLAXOSMITHKLINE SANTÉ GRAND PUBLIC, RUEIL-MALMAISON
FR
VOLTARENE EMULGEL 1%, gel
not available 328 869-7 GLAXOSMITHKLINE SANTÉ GRAND PUBLIC, RUEIL-MALMAISON
FR
VOLTARENE EMULGEL 1%, gel
not available 372 304-1 GLAXOSMITHKLINE SANTÉ GRAND PUBLIC, RUEIL-MALMAISON
FR
VOLTARENE EMULGEL 1%, gel
not available 372 305-8 GLAXOSMITHKLINE SANTÉ GRAND PUBLIC, RUEIL-MALMAISON
FR
VOLTARENE EMULGEL 1%, gel
not available 328 870-5 GLAXOSMITHKLINE SANTÉ GRAND PUBLIC, RUEIL-MALMAISON
FR
List of nationally authorised medicinal products EMA/379050/2019 Page 55/59
VOLTARENOPHTA 0,1 POUR CENT (0,3 mg/0,3 ml), collyre en solution en récipient unidose
not available 338 685-6 LABORATOIRES THEA FR
VOLTARENOPHTA 0,1 POUR CENT (0,3 mg/0,3 ml), collyre en solution en récipient unidose
not available 338 686-2 LABORATOIRES THEA FR
VOLTARENOPHTA 0,1 POUR CENT (0,3 mg/0,3 ml), collyre en solution en récipient unidose
not available 338 687-9 LABORATOIRES THEA FR
VOLTARENOPHTABAK 1 mg/ml, collyre en solution
FR/H/0296/001 366822-4 LABORATOIRES THEA FR
VOLTARENSPE 1% gel not available 372300-6 GLAXOSMITHKLINE SANTÉ GRAND PUBLIC, RUEIL-MALMAISON
FR
VOLTARENSPE 1% gel not available 340 761-8 GLAXOSMITHKLINE SANTÉ GRAND PUBLIC, RUEIL-MALMAISON
FR
VOLTARENSPE 1% gel not available 340 762-4 GLAXOSMITHKLINE SANTÉ GRAND PUBLIC, RUEIL-MALMAISON
FR
VOLTARENSPE 1% gel not available 372 301-2 GLAXOSMITHKLINE SANTÉ GRAND PUBLIC, RUEIL-MALMAISON
FR
Voltarol 1.16% Emulgel, gel
not available PL 44673/0157 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
UK
List of nationally authorised medicinal products EMA/379050/2019 Page 56/59
Voltarol 11,6 mg/g (1,16%) gel
not available 03-2300 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
NO
Voltarol 12 Hour Joint Pain Relief 2.32% Gel
not available PL 44673/0154 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
UK
Voltarol 140 mg Medicated Plaster
DE/H/2679/001 PL 44673/0158 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
UK
Voltarol 140 mg medisinert plaster
DE/H/2679/001 11-8696 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
NO
Voltarol Back and Muscle Pain Relief 1.16% Gel
not available PL 44673/0156 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
UK
VOLTAROL EMULGEL 1%w/w Gel
not available PA 678/140/1 GLAXOSMITHKLINE CONSUMER HEALTHCARE (IRELAND) LTD
IE
VOLTAROL EMULGEL 1.16%W/W
not available PL 44673/0157 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
UK
Voltarol Emulgel P not available PL 44673/0155 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
UK
Voltarol Emulgel P 1%w/w Gel
not available PA0678/140/002 GLAXOSMITHKLINE CONSUMER HEALTHCARE (IRELAND) LTD
IE
Voltarol Extra Strength 2% w/w Gel
not available PA 678/140/3 GLAXOSMITHKLINE CONSUMER HEALTHCARE (IRELAND) LTD
IE
List of nationally authorised medicinal products EMA/379050/2019 Page 57/59
Voltarol Forte 23,2 mg/g (2,32 %) gel.
not available 10-7734 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
NO
Voltarol Joint Pain Relief 2.32% Gel
not available PL 44673/0160 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
UK
Voltarol Ophtha not available PL 20162/0018 LABORATOIRES THEA UK
Voltarol Ophtha Multidose 0.1% Eye Drops
not available PL 20162/0017 LABORATOIRES THEA UK
Voltarol Ophtha Multidose 1mg/ml Eye Drops Solution
not available PA 1107/009/002 LABORATOIRES THEA IE
Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel
not available PL 44673/0155 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
UK
Voltarol Pain-eze Emulgel®
not available PL 44673/0156 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
UK
Voltarol, medicinsk plaster DE/H/2679/001 49708 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
DK
Voltarol® 12 Hour Emulgel 2.32% Gel
not available PL 44673/0160 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
UK
Voltarol® 12 Hour Emulgel® P 2.32% Gel
not available PL 44673/0154 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
UK
List of nationally authorised medicinal products EMA/379050/2019 Page 58/59
Voltarol® Extra Strength Emulgel 2.32% Gel
not available PL 44673/0160 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
UK
Voltarol® Extra Strength Emulgel® P 2.32% Gel
not available PL 44673/0154 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
UK
VURDON ® Δερματικό διάλυμα. 1,5 % w/w
not available 11380 HELP ABEE GR
Weavor 140 mg wirkstoffhaltiges Pflaster
BE/H/0245/001 BE498666 IBSA FARMACEUTICI ITALIA BE
Weavor emplâtre médicamenteux 140 mg
BE/H/0245/001 BE498666 IBSA FARMACEUTICI ITALIA BE
Weavor, 140 mg, pleister BE/H/0245/001 BE498666 IBSA FARMACEUTICI ITALIA BE
Zaflex , 10 mg/g, gel not available 5651542 CUIDAFARMA, LDA. PT
Zaflex , 10 mg/g, gel not available 5651526 CUIDAFARMA, LDA. PT
Zaflex , 10 mg/g, gel not available 5651534 CUIDAFARMA, LDA. PT
ZEROFLOG 0,011 g/15 ml collutorio, 12 bustine
not available 034373 023 VALEAS S.P.A. IT
List of nationally authorised medicinal products EMA/379050/2019 Page 59/59
ZEROFLOG 0,074 g/100 ml collutorio, 1 flacone
not available 034373 011 VALEAS S.P.A. IT
ZEROFLOG 0,022 g/15 ml soluzione spray per mucosa orale
not available 034373 035 VALEAS S.P.A. IT
ZILIPROL 1,5% w/w δερματικό διάλυμα
not available 91291/14/23-03-2015 MEDICAIR BIOSCIENCE LABORATORIES ΑΝΩΝΥΜΗ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΤΑΙΡΕΙΑ
GR
ВОЛТАРЕН ЕМУЛГЕЛ 1.16% Гел
not available 20011208 GLAXOSMITHKLINE DUNGARVAN LIMITED
BG
ГЛИМБАКС 0,074 % промивка за уста
not available 20050526 ANGELINI PHARMA BULGARIA EOOD
BG
ГЛИМБАКС 0,148% спрей за устна лигавица, разтвор
not available 20130096 ANGELINI PHARMA BULGARIA EOOD
BG
ДИКЛОAБАК 1 mg/ml капки за очи, разтвор
FR/H/0296/001 20120184 LABORATOIRES THEA BG
НАКЛОФ 0,1 % капки за очи, разтвор
not available 20010897 LABORATOIRES THEA BG
