Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 30 September 2013 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2013-10-25
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2013311EN.01000801.xml










25.10.2013   


EN


Official Journal of the European Union


C 311/8





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 30 September 2013

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
 (1)
or Article 38 of Directive 2001/82/EC
 (2)
)

2013/C 311/02
—   Issuing, maintenance or modification of a national marketing authorization










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorization


Member State concerned


Date of notification




5.9.2013


Okrido


See Annex I


See Annex I


6.9.2013




24.9.2013


Deltanil


See Annex II


See Annex II


26.9.2013




13.9.2013


Iron


See Annex III


See Annex III


16.9.2013




18.9.2013


Aprotinin


See Annex IV


See Annex IV


19.9.2013




25.9.2013


Cydectin


See Annex V


See Annex V


26.9.2013




12.9.2013


Targocid


See Annex VI


See Annex VI


13.9.2013




5.9.2013


Flupirtine


See Annex VII


See Annex VII


6.9.2013




6.9.2013


Doramectin


See Annex VIII


See Annex VIII


9.9.2013




25.9.2013


Diclofenac


See Annex IX


See Annex IX


26.9.2013




27.9.2013


Ergot derivatives (dihydroergocristine)


See Annex X


See Annex X


30.9.2013




27.9.2013


Ergot derivatives (dihydroergocryptine)


See Annex XI


See Annex XI


30.9.2013




27.9.2013


Ergot derivatives (nicergoline)


See Annex XII


See Annex XII


30.9.2013




27.9.2013


Ergot derivatives (dihydroergotamine)


See Annex XIII


See Annex XIII


30.9.2013







—   Suspension of a national marketing authorization










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorization


Member State concerned


Date of notification




27.9.2013


Ergot derivatives (dihydroergocristine)


See Annex X


See Annex X


30.9.2013




27.9.2013


Ergot derivatives (dihydroergocryptine)


See Annex XI


See Annex XI


30.9.2013




27.9.2013


Ergot derivatives (nicergoline)


See Annex XII


See Annex XII


30.9.2013




27.9.2013


Ergot derivatives (dihydroergotamine)


See Annex XIII


See Annex XIII


30.9.2013







—   Lift of suspension of a national marketing authorization










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorization


Member State concerned


Date of notification




18.9.2013


Aprotinin


See Annex IV


See Annex IV


19.9.2013






(1)  OJ L 311, 28.11.01, p. 67.

(2)  OJ L 311, 28.11.01, p. 1.


ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT/ MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES













Member State
EU/EEA


Marketing authorisation holder


Applicant


Invented name / Name


Strength


Pharmaceutical form


Route of administration


Content (concentration)




Germany


 







Pharmapol Arzneimittelvertrieb-GmbH,




Kaddenbusch 11, 25578 Daegeling,




Germany






Okrido


6 mg/ml


Oral Solution


Oral use


 




Netherlands


 







Pharmapol Arzneimittelvertrieb-GmbH,




Kaddenbusch 11, 25578 Daegeling,




Germany






Okrido


6 mg/ml


Oral Solution


Oral use


 




United Kingdom







Pharmapol Arzneimittelvertrieb-GmbH,




Kaddenbusch 11, 25578 Daegeling,




Germany






 


Okrido


6 mg/ml


Oral Solution


Oral use


 







ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES













Member State EU/EEA


Applicant


Name


INN


Strength


Pharmaceutical form


Animal species


Route of administration




Austria







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil 10 mg/ml Pour- on Lösung zum Übergießen für Rinder und Schafe


Deltamethrin


10 mg/ml


Pour-on solution


Cattle and sheep


Topical use




Belgium







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil 10 mg/ml Solution pour-on pour bovins et ovins


Deltamethrin


10 mg/ml


Pour-on solution


Cattle and sheep


Topical use




Belgium







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil 100 mg Solution spot-on pour bovins


Deltamethrin


10 mg/ml


Spot-on solution


Cattle


Topical use




Bulgaria







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Делтанил 10 мг/мл пур он разтвор, предназначен за говеда и овце.


Deltamethrin


10 mg/ml


Pour-on solution


Cattle and sheep


Topical use




Cyprus







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil 10 mg/ml Διάλυμα για επίχυση για βοοειδή και πρόβατα


Deltamethrin


10 mg/ml


Pour-on solution


Cattle and sheep


Topical use




Czech Republic







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil 10 mg/ml pour-on roztok pro aplikaci na kůži skotu a ovcí


Deltamethrin


10 mg/ml


Pour-on solution


Cattle and sheep


Topical use




Denmark







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil 10 mg/ml Pour- on opløsning til kvæg og får


Deltamethrin


10 mg/ml


Pour-on solution


Cattle and sheep


Topical use




Estonia







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil, 10 mg/ml, kriipsususpensioon veistele ja lammastele


Deltamethrin


10 mg/ml


Pour-on solution


Cattle and sheep


Topical use




France







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil 10 mg/ml Solution pour-on pour bovins et ovins


Deltamethrin


10 mg/ml


Pour-on solution


Cattle and sheep


Topical use




France







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil 100 mg Solution spot-on pour bovins


Deltamethrin


10 mg/ml


Spot-on solution


Cattle


Topical use




Germany







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil 10 mg/ml Pour- on Lösung zum Übergießen für Rinder und Schafe


Deltamethrin


10 mg/ml


Pour-on solution


Cattle and sheep


Topical use




Germany







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil 100 mg Spot- on Lösung zum Auftropfen für Rinder


Deltamethrin


10 mg/ml


Spot-on solution


Cattle


Topical use




Greece







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil 10 mg/ml Διάλυμα για επίχυση για βοοειδή και πρόβατα


Deltamethrin


10 mg/ml


Pour-on solution


Cattle and sheep


Topical use




Hungary







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil 10 mg/ml Pour- on szarvasmarha és juh részére


Deltamethrin


10 mg/ml


Pour-on solution


Cattle and sheep


Topical use




Iceland







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil 10 mg/ml áhella, lausn fyrir nautgripi og sauöfé


Deltamethrin


10 mg/ml


Pour-on solution


Cattle and sheep


Topical use




Ireland







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil 10 mg/ml Pour- on Solution for cattle and sheep


Deltamethrin


10 mg/ml


Pour-on solution


Cattle and sheep


Topical use




Italy







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil 10 mg/ml soluzione Pour-on per bovini ed ovini


Deltamethrin


10 mg/ml


Pour-on solution


Cattle and sheep


Topical use




Latvia







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil, 10 mg/ml, šķīdums uzliešanai uz muguras liellopiem un aitām


Deltamethrin


10 mg/ml


Pour-on solution


Cattle and sheep


Topical use




Lithuania







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil, 10 mg/ml, užpilamasis tirpalas galvijams ir avims


Deltamethrin


10 mg/ml


Pour-on solution


Cattle and sheep


Topical use




Luxembourg







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil 10 mg/ml Solution pour-on pour bovins et ovins


Deltamethrin


10 mg/ml


Pour-on solution


Cattle and sheep


Topical use




The Netherlands







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil 10 mg/ml Pour- on Oplossing voor runderen en schapen


Deltamethrin


10 mg/ml


Pour-on solution


Cattle and sheep


Topical use




The Netherlands







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil 100 mg Spot- on Oplossing voor runderen


Deltamethrin


10 mg/ml


Spot-on solution


Cattle


Topical use




Poland







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil 10mg/ml, roztwór do polewania dla bydła i owiec


Deltamethrin


10 mg/ml


Pour-on solution


Cattle and sheep


Topical use




Portugal







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil 10 mg/ml solução Spot- on para bovinos e ovinos


Deltamethrin


10 mg/ml


Pour-on solution


Cattle and sheep


Topical use




Romania







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil 10 mg/ml soluție pour-on pentru bovine și ovine


Deltamethrin


10 mg/ml


Pour-on solution


Cattle and sheep


Topical use




Slovakia







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






DELTANIL 10 mg/ml Pour-on roztok pre hovädzí dobytok a ovce


Deltamethrin


10 mg/ml


Pour-on solution


Cattle and sheep


Topical use




Slovenia







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil 10 mg/ml raztopina za kožni poliv za govedo in ovce


Deltamethrin


10 mg/ml


Pour-on solution


Cattle and sheep


Topical use




Spain







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil 10 mg/ml solución pour-on para bovino y ovino


Deltamethrin


10 mg/ml


Pour-on solution


Cattle and sheep


Topical use




United Kingdom







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil 10 mg/ml Pour- on Solution for cattle and sheep


Deltamethrin


10 mg/ml


Pour-on solution


Cattle and sheep


Topical use




United Kingdom







Virbac




1'ere Avenue, 2065m - LID




06516 Carros CEDEX FRANCE






Deltanil 100 mg Spot- on Solution for cattle


Deltamethrin


10 mg/ml


Spot-on solution


Cattle


Topical use







ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES












Member State
(in EEA)


Marketing authorisation holder


INN


Invented name


Strength


Pharmaceutical form


Route of administration




Austria







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III)-hydroxide dextran complex


CosmoFer 50 mg/ml Injektionslösung und Infusionslösung


50 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Austria







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92200 Neuilly-sur-Seine




France






Ferric carboxymaltose


Ferinject 50 mg Eisen/ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung


50 mg/ml


Solution for injection/infusion


Intravenous use




Austria







Medice Arzneimittel Pütter GmbH & Co KG




Kuhloweg 37




DE-58638 Iserlohn




Germany






Iron sucrose complex


FerMed 100 mg/5 ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung


100 mg/5 ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Austria







Fresenius Medical Care Nephrologica Deutschland GmbH




Else-Kröner-Strasse 1




61352 Bad Homburg




Germany






Iron sucrose complex


Ferrologic 20 mg/ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Austria







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III) isomaltoside complex


Monofer 100 mg/ml Injektions- oder Infusionslösung


100 mg/ml


Solution for injection/infusion


Intravenous use




Austria







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92200 Neuilly-sur-Seine




France






Iron sucrose complex


Venofer 20 mg/ml - Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Belgium







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III)-hydroxide dextran complex


Cosmofer


50 mg/ml


Solution for injection/infusion


Intravenous use




Belgium







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III) isomaltoside complex


Monover


100 mg/ml


Solution for injection/infusion


Intravenous use




Belgium







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Iron sucrose complex


Venofer


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Belgium







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Ferric Carboxymaltose


Injectafer


50 mg/ml


Solution for injection/infusion


Intravenous use




Bulgaria







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection/infusion


Intravenous use




Bulgaria







Pharmalog AG,




33 Cherni vrah blvd.,




1421 Sofia




Bulgaria






Iron sucrose complex


Idafer


20 mg/ml


Solution for injection


Intravenous use




Bulgaria







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III)-hydroxide dextran complex


Cosmofer


50 mg/ml


Solution for injection


Intravenous use




Bulgaria







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III) isomaltoside complex


Monofer


100 mg/ml


Solution for injection/infusion


Intravenous use




Cyprus







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






ferric carboxymaltose


FERINJECT SOLUTION FOR INJECTION OR INFUSION 50 MG IRON/ML


50 mg/ml


Solution for injection/infusion


Intravenous use




Cyprus







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III) isomaltoside complex


MONOFER SOLUTION FOR INJECTION OR INFUSION 100 MG/ML


100 mg/ml


Solution for injection/infusion


Intravenous use




Cyprus







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III)-hydroxide dextran complex


COSMOFER SOLUTION FOR INJECTION OR INFUSION 50 MG IRON/ML


50 mg/ml


Solution for injection/infusion


Intravenous use




Cyprus







The Star Medicines Importers & co ltd,




9A Loukis Akritas Street,




P.O.box 50151,




3601 Lemesos,




Cyprus






Iron sucrose complex


VENOFER INJECTION 100 MG IRON/5 ML


100 mg/5 ml


Solution for injection


Intravenous use




Cyprus







Fresenius Medical Care Nephrologica Deutschland GmbH




Else-Kröner-Strasse 1




61352 Bad Homburg




Germany






Iron sucrose complex


FERROLOGIC SOLUTION FOR INJECTION/CONCENTRATE FOR SOLUTION FOR INFUSION 20 MG/ML


20 mg/ml


Solution for injection/infusion


Intravenous use




Czech Republic







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Iron sucrose complex


VENOFER


20 mg/ml


Solution for injection


Intravenous use




Czech Republic







Fresenius Medical Care Nephrologica Deutschland GmbH




Else-Kröner-Strasse 1




61352 Bad Homburg




Germany






Iron sucrose complex


FERROLOGIC 20 MG/ML


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Czech Republic







PHARMABIDE LTD




20, Lakonias str, 15234 Halandri




Athens -




Greece






Iron sucrose complex


IRON SUCROSE PHARMABIDE 20 MG/ML


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Czech Republic







Orion Corporation,




Orionintie 1,




FI-02200 Espoo,




Finland






Iron sucrose complex


FERION 20 MG/ML


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Czech Republic







Sanofi-Aventis, s.r.o.




Evropská 846/176a




160 00 Praha 6




Czech Republic






sodium ferric gluconate complex


FERRLECIT


12,5 mg/ml


Solution for injection


Intravenous use




Czech Republic







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






ferric carboxymaltose


FERINJECT


50 mg/ml


Solution for injection/infusion


Intravenous use




Denmark







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III)-hydroxide dextran complex


Cosmofer


50 mg/ml


Solution for injection/infusion


Intravenous use




Denmark







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection/infusion


Intravenous use




Denmark







Orion Corporation,




Orionintie 1,




FI-02200 Espoo,




Finland






Iron sucrose complex


Ferion


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Denmark







Fresenius Medical Care Nephrologica Deutschland GmbH




Else-Kröner-Strasse 1




61352 Bad Homburg




Germany






Iron sucrose complex


Ferrologic


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Denmark







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III)-hydroxide dextran complex


Jerndextran "Pharmacosmos"


50 mg/ml


Solution for injection/infusion


Intravenous use




Denmark







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III) isomaltoside complex


MonoFer


100 mg/ml


Solution for injection/infusion


Intravenous use




Denmark







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Iron sucrose complex


Venofer


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Estonia







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Iron sucrose complex


Venofer


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Estonia







Fresenius Medical Care Nephrologica Deutschland GmbH




Else-Kröner-Strasse 1




61352 Bad Homburg




Germany






Iron sucrose complex


Ferrologic 20 mg/ml


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Estonia







Orion Corporation,




Orionintie 1,




FI-02200 Espoo,




Finland






Iron sucrose complex


Ferion


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Estonia







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron (III)-hydroxide dextran complex


Cosmofer


50 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Estonia







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III) isomaltoside complex


Monofer


100 mg/ml


Solution for injection/infusion


Intravenous use




Estonia







Lek Pharmaceuticals d.d.




Verovškova 57




1526 Ljubljana




Slovenia






Iron (III)-hydroxide dextran complex


Ferrum Lek


50 mg/ml


Solution for injection


Intramuscular use




Finland







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection/infusion


Intravenous use




Finland







Fresenius Medical Care Nephrologica Deutschland GmbH




Else-Kröner-Strasse 1




61352 Bad Homburg




Germany






Iron sucrose complex


Ferrologic


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Finland







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Iron sucrose complex


Venofer


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Finland







Alternova A/S




Lodshusvej 11




4230 Skaelskoer




Denmark






Iron sucrose complex


Venotrix


20 mg/ml


Concentrate for solution for infusion/solution for injection


Intravenous use




Finland







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III)-hydroxide dextran complex


Cosmofer


50 mg/ml


Solution for injection/infusion


Intravenous use




Finland







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III) isomaltoside complex


Monofer


100 mg/ml


Solution for injection/infusion


Intravenous use




France







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Ferric Carboxymaltose


FERINJECT 50 mg/ml, solution injectable/pour perfusion


50 mg/ml


Solution for injection/infusion


Intravenous use




France







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Iron sucrose complex


VENOFER 20 mg/ml, solution injectable


20 mg/ml


Solution for injection


Intravenous use




France







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III)-hydroxide dextran complex


FERRISAT 50 mg/ml, solution injectable ou pour perfusion


50 mg/ml


Solution for injection/infusion


Intravenous use




France







Pharmaki Generics Ltd




5 Bourlet Close




W1W 7BL London




United Kingdom






Iron sucrose complex


FER ACTAVIS 100 mg/5 ml, solution injectable


100 mg/5 ml


Solution for injection


Intravenous use




France







IBD3 Pharma Consulting




Immeuble l'Orient




10, place Charles Béraudier




69003 Lyon




France






Iron sucrose complex


FER IBD3 PHARMA CONSULTING 100 mg/5 ml, solution à diluer pour perfusion


100 mg/5 ml


Concentrate for solution for infusion


Intravenous use




France







Mylan SAS




117, allée des Parcs




69800 Saint-Priest




France






Iron sucrose complex


FER MYLAN 100 mg/5 ml, solution à diluer pour perfusion


100 mg/5 ml


Concentrate for solution for infusion


Intravenous use




France







SANDOZ




49, avenue Georges Pompidou




92300 Levallois-Perret




France






Iron sucrose complex


FER SANDOZ 100 mg/5 ml, solution à diluer pour perfusion


100 mg/5 ml


Concentrate for solution for infusion


Intravenous use




France







TEVA SANTE




110, Esplanade du Général de Gaulle




92931 Paris La Défense Cedex




FRANCE






Iron sucrose complex


FER TEVA PHARMA 100 mg/5 ml, solution injectable (IV)


100 mg/5 ml


Solution for injection


Intravenous use




Germany







Fresenius Medical Care Nephrologica Deutschland GmbH




Else-Kröner-Strasse 1




61352 Bad Homburg




Germany






Iron sucrose complex


Ferrologic 20 mg/ml Injektionslösung/ Konzentrat zur Herstellung einer Infusionslösung


1 709 mg/5 ml


Concentrate for solution for infusion/solution for injection


Intravenous use




Germany







Medice Arzneimittel Pütter GmbH & Co KG




Kuhloweg 37




DE-58638 Iserlohn




Germany






Iron sucrose complex


FerMed


1 563 - 1 887 mg/5 ml


Concentrate for solution for infusion/solution for injection


Intravenous use




Germany







Medice Arzneimittel Pütter GmbH & Co KG




Kuhloweg 37




DE-58638 Iserlohn




Germany






Iron sucrose complex


Nefro-Fer


1 563 - 1 887 mg/5 ml


Solution for injection


Intravenous use




Germany







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III) isomaltoside complex


Monofer 100 mg/ml Lösung zur Injektion/Infusion


377-465 mg/ml


Solution for injection/infusion


Intravenous use




Germany







Sanofi-Aventis Deutschland GmbH




Brüningstrasse 50,




D-65926 Frankfurt am Main




Germany






sodium ferric gluconate complex


Ferrlecit 40 mg


1 288,9 mg/3.2 ml


Solution for injection


Intravenous use




Germany







Sanofi-Aventis Deutschland GmbH




Brüningstrasse 50,




D-65926 Frankfurt am Main




Germany






sodium ferric gluconate complex


Ferrlecit 62,5 mg


2 013,9 mg/5 ml


Solution for injection


Intravenous use




Germany







Pharmacosmos A/S




Roervangsvei 30




Holbaek DK-4300




Denmark






Iron(III)-hydroxide dextran complex


CosmoFer 50 mg/ml Injektionslösong und Infusionslösung


312,5 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Germany







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Ferric carboxymaltose complex


FERINJECT 50 mg Eisen/ml Injektions- und Infusionslösung


180 mg/ml


Solution for injection/infusion


Intravenous use




Germany







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Iron sucrose complex


Venofer 20 mg FR / ml Injektionslösung


2 700 mg/5ml


Concentrate for solution for infusion/solution for injection


Intravenous use




Greece







Medicus SA




Valaoritou 10




Metamorfosi




Attikis 14452




Greece






Iron sucrose complex


REOXYL


100 mg/5 ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Greece







Vianex S.A.




Tatoiou Street




Nea Erythrea 14671




Greece






Iron sucrose complex


INTRAFER


100 mg/5 ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Greece







Alapis ABEE




Aftokratoros Nikolaou 2




Athens 17671




Greece






Iron sucrose complex


FAREMIO


100 mg/5 ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Greece







Intermed ABEE




Kalyftaki 27




Athens 14564




Greece






Iron sucrose complex


DEXTRIFER-S


100 mg/5 ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Greece







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Iron sucrose complex


VENOFER


100 mg/5 ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Greece







Demo ABEE




21ST Km National Highway




Athens-Lamia, 14565




Greece






Iron (III) hydroxide dextran


COSMOFER


50 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Greece







Rafarm AEBE




Korinthou 12,




N. Psychiko, 15451




Greece






Iron sucrose complex


FERROVIN


100 mg/5 ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Greece







Nephrotech S.A.




Parnithos 44




Metamorfosi Attikis 14452




Greece






Iron sucrose complex


SUCRO-FER


100 mg/5 ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Greece







Uni-Pharma Kleon Tseitis




Pharmaceutical Laboratories




14KM National Highway




Athens-Lamia




Kifissia 14564




Greece






Iron sucrose complex


HEMAFER-S


100 mg/5 ml


Concentrate for solution for infusion


Intravenous use




Greece







Verisfield (UK) Ltd, U.K.




41 Chalton street




London, NW1 1JD




United Kingdom






Iron sucrose complex


NEPHROFEROL


100 mg/5 ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Greece







HELP ABEE




Valaoritou 10




Metamorfosi




Attikis, 14452




Greece






Iron sucrose complex


FERRINEMIA


100 mg/5 ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Greece







Specifar AEBE




28th October Street 1




Agia Barbara 12351




Greece






Iron sucrose complex


ALVOFER


100 mg/5 ml


Concentrate for solution for infusion


Intravenous use




Greece







Alet Pharmaceuticals




M. Alexander 121,




Agia Varvara, 12351




Greece






Iron sucrose complex


SUCROVEN


100 mg/5 ml


Concentrate for solution for infusion


Intravenous use




Greece







Target Pharma Ltd




Menandrou 54




Athens 10431




Greece






Iron sucrose complex


IRONCROSE


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Greece







HELP ABEE




Valaoritou 10




Metamorfosi




Attikis, 14452




Greece






Iron(III)-hydroxide dextran complex


IRONATE


50 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Greece







Demo ABEE




21st km National Highway




Athens-Lamia, 14565




Greece






Iron(III) isomaltoside complex


MONOFER


100 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Greece







Viofar EPE




Ethnikis Antistaseos & Trifyllias,




Aharnai, 13671




Greece






Iron sucrose complex


VENIRON


100 mg/5 ml


Concentrate for solution for infusion


Intravenous use




Greece







Medicus SA




Valaoritou 10




Metamorfosi




Attikis 14452




Greece






Iron(III)-hydroxide dextran complex


IRON (III)-HYDROXIDE DEXTRAN COMPLEX/BIOMEDIC LABORATORIES


50 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Hungary







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection/infusion


Intravenous use




Hungary







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Iron sucrose complex


Venofer


20 mg/ml


Solution for injection/infusion


Intravenous use




Hungary







Fresenius Medical Care Nephrologica Deutschland GmbH




Else-Kröner-Strasse 1




61352 Bad Homburg




Germany






Iron sucrose complex


Ferrologic


20 mg/ml


Solution for injection/infusion


Intravenous use




Hungary







Sanofi-Aventis Zrt




Tó utca 1-5,




1045 Budapest




Hungary






Sodium ferric gluconate complex


Ferrlecit


12,5 mg/ml


Solution for injection


Intravenous use




Iceland







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection/infusion


Intravenous use




Iceland







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III) isomaltoside complex


Monofer


100 mg/ml


Solution for infusion


Intravenous use




Iceland







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Iron sucrose complex


Venofer


20 mg/ml


Solution for injection


Intravenous use




Ireland







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron (III) hydroxide dextran complex


CosmoFer 50 mg/ml solution for infusion and injection


50 mg/ml


Solution for injection/infusion


Intravenous use




Ireland







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III) isomaltoside complex


Monover 100 mg/ml solution for injection/infusion (ampoules)


100 mg/ml


Solution for injection/infusion


Intravenous use




Ireland







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III) isomaltoside complex


Monover 100 mg/ml solution for injection/infusion (vials)


100 mg/ml


Solution for injection/infusion


Intravenous use




Ireland







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Iron sucrose complex


Venofer 20 mg iron/ml solution for injection or concentrate for solution for infusion, ampoule


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Ireland







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






ferric carboxymaltose


FERINJECT 50 mg iron/ml solution for injection/infusion


50 mg/ml


Solution for injection/infusion


Intravenous use




Ireland







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Iron sucrose complex)


Venofer 20 mg iron/ml solution for injection or concentrate for solution for infusion, vial


20 mg/ml


Solution for injection/infusion


Intravenous use




Ireland







Fresenius Medical Care Nephrologica Deutschland GmbH




Else-Kröner-Strasse 1




61352 Bad Homburg




Germany






Iron sucrose complex


FerroLogic 20 mg/ml solution for injection/concentrate for solution for infusion


20 mg/ml


Solution for injection


Intravenous use




Italy







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






ferric carboxymaltose


FERINJECT


50 mg/ml


Solution for injection/infusion


Intravenous use




Italy







Fresenius Medical Care Nephrologica Deutschland GmbH




Else-Kröner-Strasse 1




61352 Bad Homburg




Germany






Iron sucrose complex


FERRO SACCARATO FME


20 mg/ml


Concentrate for solution for infusion/solution for injection


Intravenous use




Italy







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Iron sucrose complex


VENOFER


20 mg/ml


Solution for injection


Intravenous use




Italy







Sanofi-Aventis SPA




Viale Luigi Bodio, 37/B




20158 Milano




Italy






sodium ferric gluconate complex


FERLIXIT


62,5 mg/5 ml


Oral solution or solution for infusion


Oral use
Intravenous use




Latvia







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection/infusion


Intravenous use




Latvia







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Iron sucrose complex


Venofer


20 mg/ml


Solution for injection


Intravenous use




Latvia







Fresenius Medical Care Nephrologica Deutschland GmbH




Else-Kröner-Strasse 1




61352 Bad Homburg




Germany






Iron sucrose complex


FerroLogic


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Latvia







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron (III) hydroxide dextran complex


CosmoFer


50 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Latvia







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III) isomaltoside complex


Monofer


100 mg/ml


Solution for injection/infusion


Intravenous use




Lithuania







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection/infusion


Intravenous use




Lithuania







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Iron sucrose complex


Venofer


20 mg/ml


Solution for injection


Intravenous use




Lithuania







Fresenius Medical Care Nephrologica Deutschland GmbH




Else-Kröner-Strasse 1




61352 Bad Homburg




Germany






Iron sucrose complex


Ferrologic


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Lithuania







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III) isomaltoside complex


Monofer


100 mg/ml


Solution for injection/infusion


Intravenous use




Lithuania







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Ferric (III) hydroxide dextran complex


CosmoFer


50 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Luxembourg







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Ferric carboxymaltose


Injectafer-50 mg/l


50 mg/ml


Solution for injection


Intravenous use




Luxembourg







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III)-hydroxide dextran complex


Cosmofer-50 mg/ml


50 mg/ml


Solution for injection


Intravenous use




Luxembourg







Medice Arzneimittel Pütter GmbH & Co KG




Kuhloweg 37




DE-58638 Iserlohn




Germany






Iron sucrose complex


Fermed-100 mg/5 ml


100 mg/5 ml


Solution for perfusion


Intravenous use




Luxembourg







Fresenius Medical Care Nephrologica Deutschland GmbH




Else-Kröner-Strasse 1




61352 Bad Homburg




Germany






Iron sucrose complex


Ferrologic-20 mg/ml


20 mg/ml


Solution for perfusion


Intravenous use




Malta







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92200 Neuilly-sur-Seine




France






ferric carboxymaltose


FERINJECT 50 mg iron/ml solution for injection/infusion


50 mg/ml


Solution for injection/infusion


Intravenous use




Malta







Fresenius Medical Care Nephrologica Deutschland GmbH




Else-Kröner-Strasse 1




61352 Bad Homburg




Germany






Iron sucrose complex.


Ferrologic 20 mg/ml solution for injection/concentrate for solution for infusion


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Norway







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III)-hydroxide dextran complex


Cosmofer


50 mg/ml


Solution for injection/infusion


Parenteral use




Norway







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection/infusion


Parenteral use




Norway







Orion Corporation,




Orionintie 1,




FI-02200 Espoo,




Finland






Iron sucrose complex


Ferion


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Parenteral use




Norway







Fresenius Medical Care Nephrologica Deutschland GmbH




Else-Kröner-Strasse 1




61352 Bad Homburg




Germany






Iron sucrose complex


Ferrologic


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Parenteral use




Norway







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III) isomaltoside complex


Monofer


100 mg/ml


Solution for injection/infusion


Parenteral use




Norway







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III)-hydroxide dextran complex


Uniferon


200 mg/ml


Solution for injection


Parenteral use




Norway







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Iron sucrose complex


Venofer


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Parenteral use




Poland







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III)-hydroxide dextran complex


CosmoFer


50 mg/ml


Solution for injection/infusion


Intravenous use




Poland







VIFOR France SA




123 Rue Jules Guesde




92200 Neuilly-sur-Seine




France






ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection


Intravenous use




Poland







VIFOR France SA




123 Rue Jules Guesde




92200 Neuilly-sur-Seine




France






Iron sucrose complex


Venofer


20 mg/ml


Solution for injection/infusion


Intravenous use




Poland







Fresenius Medical Care Nephrologica Deutschland GmbH




61346 Bad Homburg




Germany






Iron sucrose complex


Ferrologic 20 mg/ml


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Poland







Sandoz GmbH




Biochemiestrasse 10




A-6250 Kundl




Austria






Iron(III) isomaltoside complex


Ferrum-Lek


50 mg/ml


Solution for injection


Intramuscular use




Poland







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III) isomaltoside complex


Monover


100 mg/ml


Solution for injection/infusion


Intravenous use




Portugal







Fresenius Medical Care Nephrologica Deutschland GmbH




Else-Kröner-Strasse 1




61352 Bad Homburg




Germany






Iron sucrose complex


Referen


100 mg/5 ml


Solution for injection


Intravenous use




Portugal







Vifor France, SA




7-13 Boulevard Paul Emile Victor




92200 Neuilly-sur-Seine




France






Iron sucrose complex


Venofer


100 mg/5 ml


Solution for injection


Intravenous use




Portugal







Combino Pharm Portugal, Unipessoal, Lda.




Lagoas Park




Edifício 8




Piso 0 2740-268 Porto Salvo




Portugal






Iron sucrose complex


Óxido Férrico Sacarosado Combino


100 mg/5 ml


Solution for injection


Intravenous use




Portugal







Farmoz - Sociedade Técnico Medicinal, S.A.




Rua da Tapada Grande, 2,




Abrunheira




2710-089 Sintra




Portugal






Iron sucrose complex


Óxido Férrico Sacarosado Farmoz


100 mg/5 ml


Solution for injection


Intravenous use




Portugal







Generis Farmacêutica, S.A.




Rua João de Deus, 19




2700-487 Amadora




Portugal






Iron sucrose complex


Óxido Férrico Sacarosado Generis


100 mg/5 ml


Solution for injection


Intravenous use




Portugal







Laboratórios Normon, S.A.




Rua Armando Villar,




Lote 42 1o Dto. Quinta das Patinhas, Cobre




2750 - 777 Cascais




Portugal






Iron sucrose complex


Óxido Férrico Sacarosado Normon


100 mg/5 ml


Solution for injection


Intravenous use




Portugal







Vifor France, SA




7-13 Boulevard Paul Emile Victor




92200 Neuilly-sur-Seine




France






Ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection/infusion


Intravenous use




Portugal







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III)-hydroxide dextran complex


Cosmofer


50 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Portugal







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III)-hydroxide dextran complex


Monofar


100 mg/ml


Solution for injection/infusion


Intravenous use




Romania







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Iron sucrose complex


VENOFER®


20 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Romania







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III) isomaltoside complex


MONOFER 100 mg/ml


100 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Romania







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Ferric carboxymaltose


FERINJECT 50 mg fer/ml


50 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Slovak Republic







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection/infusion


Intravenous use




Slovak Republic







Orion Corporation,




Orionintie 1,




FI-02200 Espoo,




Finland






Iron sucrose complex


Ferion 20 mg/ml


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Slovak Republic







Fresenius Medical Care Nephrologica Deutschland GmbH




Else-Kröner-Strasse 1




61352 Bad Homburg




Germany






Iron sucrose complex


Ferrologic 20 mg/ml


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Slovak Republic







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Iron sucrose complex


Venofer


20 mg/ml


Solution for injection


Intravenous use




Slovenia







Fresenius Medical Care Nephrologica Deutschland GmbH




Else-Kröner-Strasse 1




61352 Bad Homburg




Germany






Iron sucrose complex


Ferrologic 20 mg/ml raztopina za injiciranje/ koncentrat za raztopino za infundiranje


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Slovenia







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






carboxymaltose


Iroprem 50 mg/ml raztopina za iniciranje ali infundiranje


50 mg/ml


Solution for injection/infusion


Intravenous use




Slovenia







Lek farmacevtska družba d.d.,




Verovškova 57,




1000 Ljubljana




Slovenia






Iron sucrose complex


Venofer 20 mg/ml raztopina za injiciranje/ koncentrat za raztopino za infundiranje


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Spain







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III)-hydroxide dextran complex


COSMOFER 50 mg/ml SOLUCION PARA PERFUSION E INYECCION


50 mg/ml


Solution for injection
Solution for infusion


Intravenous use
intramuscular use




Spain







GUERBET B.P.




57400 ROISSY CdG




CEDEX F-95943




France






Iron sucrose complex


ENDOREM 11,2 mg FE/ml CONCENTRADO PARA SUSPENSION PARA PERFUSION


11,2 mg/ml


Concentrate for suspension for infusion


Intravenous use




Spain







G.E.S. Genericos Espanoles Laboratorio




S.A.Cólquide, 6 - Portal 2, 1




Oficina F.Las Rozas




28230 MADRID




Spain






Iron sucrose complex


FERIV 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Spain







Fresenius Medical Care Nephrologica Deutschland GmbH




Else-Kröner-Strasse 1




61346 Bad Homburg




Germany






Iron sucrose complex


HIERRO SACAROSA FME 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Spain







Laboratorios Normon S.A.




Ronda de Valdecarrizo 6




28760 Tres Cantos




Madrid




Spain






Iron sucrose complex


HIERRO SACAROSA NORMON 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Spain







Medice Arzneimittel Pütter GmbH & Co KG




Kuhloweg 37




DE-58638 Iserlohn




Germany






Iron sucrose complex


FERMED 100 mg/ 5 ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION


100 mg/5 ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Spain







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Iron sucrose complex


VENOFER 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Spain







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Ferric carboxymaltose


FERINJECT 50 mg/ml SOLUCION INYECTABLE Y PARA PERFUSION


50 mg/ml


Solution for injection
Solution for infusion


Intravenous use




Spain







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III) isomaltoside complex


MONOFERRO 100 mg/ml SOLUCIÓN INYECTABLE O PARA PERFUSIÓN


100 mg/ml


Solution for injection
Solution for infusion


Intravenous use




Sweden







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92200 Neuilly-sur-Seine




France






Iron sucrose complex


Venofer®


20 mg/ml


Concentrate for solution for injection


Intravenous use




Sweden







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III)-hydroxide dextran complex


Cosmofer®


50 mg/ml


Solution for injection


Intravenous use




Sweden







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92200 Neuilly-sur-Seine




France






Ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection


Intravenous use




Sweden







Fresenius Medical Care Nephrologica Deutschland GmbH




Else-Kröner-Strasse 1




61346 Bad Homburg




Germany






Iron sucrose complex


Ferrologic


20 mg/ml


Concentrate for solution for injection


Intravenous use




Sweden







Orion Corporation,




Orionintie 1,




FI-02200 Espoo,




Finland






Iron sucrose complex


Ferion


20 mg/ml


Concentrate for solution for injection


Intravenous use




Sweden







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III) isomaltoside complex


MonoFer®


100 mg/ml


Solution for injection


Intravenous use




The Netherlands







Pharmamatch B.V.




Egelenburg 2




Amsterdam GK - 1081




The Netherlands






Iron sucrose complex


IJzerhydroxide sacharose complex bevattende 20 mg/ml IJzer PHARMAMATCH, oplossing/concentraat voor oplossing voor injectie


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




The Netherlands







Fresenius Medical Care Nephrologica Deutschland GmbH




Else-Kröner-Strasse 1




61352 Bad Homburg




Germany






Iron sucrose complex


FerroLogic 20 mg/ml, oplossing voor injectie of concentraat voor oplossing voor infusie


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




The Netherlands







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III) isomaltoside complex


MonoFer 100 mg/ml oplossing voor injectie/infusie


100 mg/ml


Solution for injection/infusion


Intravenous use




The Netherlands







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Iron sucrose complex


Venofer 20 mg/ml ijzer (III), oplossing voor injectie of concentraat voor oplossing voor intraveneuze infusie


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




The Netherlands







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Ferric carboxymaltose


FERINJECT 50 mg ijzer/ ml, oplossing voor injectie/infusie


50 mg/ml


Solution for injection/infusion


Intravenous use




The Netherlands







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III)-hydroxide dextran complex


CosmoFer 50 mg/ml oplossing voor infusie en injectie


50 mg/ml


Solution for injection/infusion


Intravenous use




The Netherlands







Pharmachemie B.V.




Haarlem - 2031 GA




The Netherlands






Iron sucrose complex


IJzerhydroxide sacharose complex 20 mg/ml PCH, oplossing voor injectie/concentraat voor oplossing voor infusie


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




United Kingdom







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Iron sucrose complex


Venofer


20 mg/ml


Solution for injection/infusion


Intravenous use




United Kingdom







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III) isomaltoside complex


Monofer


100 mg/ml


Solution for injection/infusion


Intravenous use




United Kingdom







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III) isomaltoside complex


Diafer


50 mg/ml


Solution for injection


Intravenous use




United Kingdom







Pharmacosmos A/S




Roervangsvej 30




Holbaek DK-4300




Denmark






Iron(III)-hydroxide dextran complex


Cosmofer


50 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




United Kingdom







Fresenius Medical Care Nephrologica Deutschland GmbH




Else-Kröner-Strasse 1




61352 Bad Homburg




Germany






Iron sucrose complex


Ferrologic


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




United Kingdom







VIFOR France SA




7-13 Boulevard Paul Emile Victor




92521 Neuilly-sur-Seine




France






Ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection/infusion


Intravenous use







ANNEX IV

LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES


Aprotinin containing medicinal products with Marketing Authorisation in the European Union











Member State
(EU/EEA)


Marketing Authorisation Holder


Invented name


Strength


Pharmaceutical form


Route of administration




AT - Austria







Bayer Austria GmbH




Herbststraße 6-10




A-1160 Wien




Austria






Trasylol 10 000 KIE/ml - Infusionsflasche


10 000 KIU/ml


solution for infusion


intravenous use




BE-Belgium







Belgium Bayer S.A.




14, J.E. Mommaertslaan




B- 1831 Diegem




Belgium






Trasylol


10 000 KIU/ml


solution for infusion


intravenous use




CZ - Czech Republic







Chemical Works of Gedeon Richter Plc.,




HU-1103 Budapest,




Gyömrői út 19-21.,




Hungary






Gordox


10 ku/ml


solution for injection


intravenous use




CZ - Czech Republic







Bayer Schering Pharma AG




Mullerstrasse 178




13353 Berlin




Germany






Trasylol 500 000 KIE


10 ku/ml


solution for infusion


intravenous use




DE - Germany


Bayer Pharma Aktiengesellschaft
registered business address:





Müllerstr. 178




D-13353 Berlin




postal address:




D-13342 Berlin






Trasynin 0,5


70,0 mg /50 ml


solution for infusion


intravenous use




DE - Germany


Bayer Pharma Aktiengesellschaft
registered business address:





Müllerstr. 178




D-13353 Berlin




postal address:




D-13342 Berlin






Trasynin 1,0


140,0 mg /100 ml


solution for infusion


intravenous use




DE - Germany


Bayer Pharma Aktiengesellschaft
registered business address:





Müllerstr. 78




D-13353 Berlin




postal address:




D-13342 Berlin






Trasynin 2,0


280,0 mg /200 ml


solution for infusion


intravenous use




DE - Germany







Bayer Vital GmbH




D-51373 Leverkusen






Trasylol 0,5


70,0 mg /50 ml


solution for infusion


intravenous use




DE - Germany







Bayer Vital GmbH




D-51373 Leverkusen






Trasylol 1,0


140,0 mg /100 ml


solution for infusion


intravenous use




DE - Germany







Bayer Vital GmbH




D-51373 Leverkusen






Trasylol 2,0


280,0 mg /200 ml


solution for infusion


intravenous use




DK - Denmark







Bayer Schering Pharma AG,




Müllerstrasse 170-178,




DE-13342 Berlin,




Germany






Trasylol


10 000 KIE/ml


solution for injection


intravenous use




EL - Greece







Bayer Hellas AG




18 - 20, Sorou Str.




151 25, Marousi - Athens






TRASYLOL


500 000 KIU/50ML


solution for infusion


intravenous use




ES - Spain







QUIMICA FARMACEUTICA BAYER, S.L




Av. Baix Llobregat, 3-5




08970 Sant Joan Despi




Barcelona - España






TRASYLOL SOLUCIÓN PARA PERFUSIÓN INTRAVENOSA


10 000 K 10 000 KIU/ml IU/ml


solution for perfusion


intravenous use




FI - Finland







Bayer HealthCare AG,




51368 Leverkusen,




Germany






TRASYLOL


10 000 KIU/ml


solution for injection/infusion


intravenous use




FR - France







BAYER SANTE - 220,




avenue de la recherche - 59120 LOOS






Trasylol


1 000 000 KUI/100 mL


solution for injection


intravenous use




FR - France







BAYER SANTE - 220,




avenue de la recherche - 59120 LOOS






Trasylol


2 000 000 KUI/200 mL


solution for injection


intravenous use




FR - France







BAYER SANTE - 220,




avenue de la recherche - 59120 LOOS






Trasylol


500 000 UIK/50 mL


solution for injection


intravenous use




HU - Hungary







Richter Gedeon Nyrt.




Gyömrői út 19-21.




1103 Budapest,




Hungary






Gordox


100 000 KIU/10 ml


solution for injection


intravenous use




HU - Hungary







Richter Gedeon Nyrt.




Gyömrői út 19-21.




1103 Budapest,




Hungary






Gordox


500 000 KIU/50 ml


solution for infusion


intravenous use




HU - Hungary







Bayer Healthcare AG




Kaiser-Wilhelm-Allee, Bldg. E39




51368 Leverkusen,




Germany






Trasylol


500 000 KIU/50 ml


solution for infusion


intravenous use




LU - Luxembourg







Bayer S.A.




14, J.E. Mommaertslaan




B- 1831 Diegem






TRASYLOL


50 000 U/50ml


solution for injection


intravenous use




LV - Latvia







Gedeon Richter Ltd.




Gyomroi ut 19-21




Budapest HU-1103




Hungary






Gordox 10 000 KSV/ml šķīdums infūzijām


10 000 KIU/ml


solution for infusion


intravenous use




MT - Malta







Bayer Plc




Bayer House




Strawberry Hill




Newbury




Berkshire RG14 1JA




United Kingdom




trading as Bayer Plc, Pharmaceutical division


TRASYLOL


10 000 KIU/ML


solution for infusion


intravenous use




NL - Netherlands







Bayer B.V.




Energieweg 1




3641 RT Mijdrecht




The Netherlands






Trasylol 500 000, oplossing voor infusie 10 000 KIE/ml


10 000 KIU/ml


solution for infusion


intravenous use




PL - Poland







Bayer Pharma AG




Berlin, D-13342




Germany






Trasylol


555,6 Ph.Eur.u. (1 000 000 KIU)


solution for infusion


intravenous use




PL - Poland







Bayer Pharma AG




Berlin, D-13342




Germany






Trasylol


1 111,1 Ph.Eur.u. (2 000 000 KIU)


solution for infusion


intravenous use




PL - Poland







Bayer Pharma AG




Berlin, D-13342




Germany






Trasylol


277,8 j. Ph. Eur. (500 000 KIU)


solution for infusion


intravenous use




PT - Portugal







Bayer Portugal, S.A.




Rua Quinta do Pinheiro 5




2794-003 Carnaxide




Portugal






Trasylol


500 000 U.I.C/50 ml


solution for infusion


intravenous use




PT - Portugal







Bayer Portugal, S.A.




Rua Quinta do Pinheiro 5




2794-003 Carnaxide




Portugal






Trasylol 1 000 000 UIC


1 000 000 U.I.C/100 ml


solution for infusion


intravenous use




PT - Portugal







Bayer Portugal, S.A.




Rua Quinta do Pinheiro 5




2794-003 Carnaxide




Portugal






Trasylol 2 000 000 UIC


2 000 000 U.I.C/200 ml


solution for infusion


Intravenous use




SE - Sweden







Bayer Schering Pharma AG




Müllerstrasse 178




DE-133 42 Berlin




Germany






Trasylol


10 000 KIE/ml


solution for injection/infusion


intravenous use




SK - Slovakia







Richter Gedeon Nyrt.,




Budapest 10,




Pf. 27., H-1475




Hungary






GORDOX


100 000 IU/10 ml


solution for injection


intravenous use




SL - Slovenia







Bayer d.o.o.,




Bravničarjeva 13,




Ljubljana,




Slovenia






TRASYLOL


10 000 KIU/ml


solution for injection and infusion


intravenous use




UK - United Kingdom







Bayer plc




Bayer House




Strawberry Hill




Newbury,




Berkshire RG14 1JA




UK






Trasylol Solution


10,000 KIU/ML


solution for injection


intravenous use




UK - United Kingdom







Nordic Pharma Limited,




Abbey House,




1650 Arlington Business Park,




Theale, Reading,




Berkshire RG7 4SA,




UK






Aprotinin 10,000 KIU/ml Injection


10,000 KIU/ml


solution for injection


intravenous use







ANNEX V

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES













Member State
EU/EEA


Marketing authorisation holder


Name


INN


Strength


Pharmaceutical form


Route of administration


Animal species




Austria







Pfizer Corp. Austria G.m.b.H.




Floridsdorfer Hauptstraße 1




A - 1210 Wien




Austria






Cydectin TriclaMox 5 mg/ml + 200 mg/ml lösung zum aufgießen für Rinder


Moxidectin


5,0 mg


Pour-on solution


Topical – on the back of the animal


Cattle




Triclabendazole


200,0 mg




Belgium







Pfizer Animal Health s.a.




Rue Laid Burniat 1




1348 Louvain-la-Neuve




Belgium






Cydectin TriclaMox 5 mg/ml + 200 mg/ml


Moxidectin


5,0 mg


Pour-on solution


Topical – on the back of the animal


Cattle




Triclabendazole


200,0 mg




Denmark







Pfizer Oy, Animal Health




Tietokuja 4




00330 Helsinki




Finland






Cydectin TriclaMox


Moxidectin


5,0 mg


Pour-on solution


Topical – on the back of the animal


Cattle




Triclabendazole


200,0 mg




France







Pfizer Holding France




23-25 avenue du Docteur Lannelongue




F – 75668 Paris Cedex 14




France






Cydectine TriclaMox 5 mg/ml + 200 mg/ml Solution pour pour-on bovins


Moxidectin


5,0 mg


Pour-on solution


Topical – on the back of the animal


Cattle




Triclabendazole


200,0 mg




Germany







Pfizer GmbH




Linkstraße 10




10785 Berlin




Germany






Cydectin® TriclaMox 5 mg/ml + 200 mg/ml Lösung zum Aufgießen für Rinder


Moxidectin


5,0 mg


Pour-on solution


Topical – on the back of the animal


Cattle




Triclabendazole


200,0 mg




Greece







Pfizer Hellas AE




Mesogion Avenue 243




154 51 N. Psychiko




Athens




Greece






Cydectin TriclaMox


Moxidectin


5,0 mg


Pour-on solution


Topical – on the back of the animal


Cattle




Triclabendazole


200,0 mg




Ireland







Pfizer Healthcare Ireland




Ringaskiddy




Co Cork




Ireland






Cydectin TriclaMox 5 mg/ml + 200 mg/ml Pour-on Solution for Cattle


Moxidectin


5,0 mg


Pour-on solution


Topical – on the back of the animal


Cattle




Triclabendazole


200,0 mg




Italy







Pfizer Italia S.r.l.




Via Isonzo 71




04100 Latina




Italy






Cydectin TriclaMox 5 mg/ml + 200 mg/ml soluzione Pour-on per bovini


Moxidectin


5,0 mg


Pour-on solution


Topical – on the back of the animal


Cattle




Triclabendazole


200,0 mg




Luxembourg







Pfizer Animal Health s.a.




Rue Laid Burniat 1




1348 Louvain-la-Neuve




Belgium






Cydectin TriclaMox 5 mg/ml + 200 mg/ml


Moxidectin


5,0 mg


Pour-on solution


Topical – on the back of the animal


Cattle




Triclabendazole


200,0 mg




Portugal







Laboratórios Pfizer, Lda




Lagoas Park – Edíficio 10




2740-271 Porto Salvo




Portugal






Cydectin TriclaMox 5 mg/ml + 200 mg/ml solução para unção contínua para bovinos


Moxidectin


5,0 mg


Pour-on solution


Topical – on the back of the animal


Cattle




Triclabendazole


200,0 mg




Slovenia







Pfizer Luxembourg SARL




51, Avenue J.F.Kennedy




L-1855 Luxembourg




Luksemburg






Cydectin TriclaMox


Moxidectin


5,0 mg


Pour-on solution


Topical – on the back of the animal


Cattle




Triclabendazole


200,0 mg




Spain







Zoetis Spain, S.L.




Avda. de Europa 20 B




Parque Empresarial La Moraleja




28108 Alcobendas (Madrid)




Spain






Cydectin Triclamox 5 mg/ml + 200 mg/ml Solución Pour-on para Bovino


Moxidectin


5,0 mg


Pour-on solution


Topical – on the back of the animal


Cattle




Triclabendazole


200,0 mg




United Kingdom







Pfizer Ltd




Ramsgate Road




Sandwich CT13 9NJ




United Kingdom






Cydectin TriclaMox 5 mg/ml + 200 mg/ml Pour-on Solution for Cattle


Moxidectin


5,0 mg


Pour-on solution


Topical – on the back of the animal


Cattle




Triclabendazole


200,0 mg







ANNEX VI

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES












Member State EU/EEA


Marketing Authorisation Holder company name, address


Invented name Name


Strength


Pharmaceutical Form


Route of administration


Content (concentration)




Austria







sanofi-aventis GmbH,




Leonard-Bernstein-Straße 10,




A-1220 Vienna,




Austria






Targocid 100 mg Trockenstechampullen mit Lösungsmittel


100 mg


powder and solvent for solution for injection/ infusion and oral solution


intramuscular use, intravenous use, oral use


100 mg/1.5 ml




Austria







sanofi-aventis GmbH,




Leonard-Bernstein-Straße 10,




A-1220 Vienna,




Austria






Targocid 200 mg Trockenstechampullen mit Lösungsmittel


200 mg


powder and solvent for solution for injection/ infusion and oral solution


intramuscular use, intravenous use, oral use


200 mg/3 ml




Austria







sanofi-aventis GmbH,




Leonard-Bernstein-Straße 10,




A-1220 Vienna,




Austria






Targocid 400 mg Trockenstechampullen mit Lösungsmittel


400 mg


powder and solvent for solution for injection/ infusion and oral solution


intramuscular use, intravenous use, oral use


400 mg/3 ml




Belgium







sanofi-aventis Belgium




Culliganlaan 1C




1831 Diegem,




Belgium






Targocid 200 mg, poeder en oplosmiddel voor oplossing voor injectie


200 mg


powder and solvent for solution for injection


intramuscular use/intravenous use


200 mg/3 ml




Belgium







sanofi-aventis Belgium




Culliganlaan 1C




1831 Diegem,




Belgium






Targocid 400 mg, poeder en oplosmiddel voor oplossing voor injectie


400 mg


powder and solvent for solution for injection


intramuscular use/intravenous use


400 mg/3 ml




Bulgaria







sanofi-aventis Bulgaria EOOD




1303 Sofia,




103 Alexander Stamboliiski Blvd. fl.8.,




Bulgaria






TARGOCID 400mg powder and solvent for solution for injection/infusion


400 mg


powder and solvent for solution for injection/infusion


intramuscular use/intravenous use, oral use


400 mg/3 ml




Czech Republic







sanofi-aventis, s.r.o.




Evropská 846/176a,




160 00 Praha 6,




Czech Republic






Targocid 200 mg


200 mg


powder and solvent for solution for injection


intramuscular use/intravenous use


200 mg/3 ml




Czech Republic







sanofi-aventis, s.r.o.




Evropská 846/176a,




160 00 Praha 6,




Czech Republic






Targocid 400 mg


400 mg


powder and solvent for solution for injection


intramuscular use/intravenous use


400 mg/3 ml




Denmark







sanofi-aventis Denmark A/S




Slotsmarken 13,




2970 Hoersholm,




Denmark






Targocid


100 mg


powder for solution for injection


intramuscular use/intravenous use


100 mg/1.5 ml




Denmark







sanofi-aventis Denmark A/S




Slotsmarken 13,




2970 Hoersholm,




Denmark






Targocid


200 mg


powder for solution for injection


intramuscular use/intravenous use


200 mg/3 ml




Denmark







sanofi-aventis Denmark A/S




Slotsmarken 13,




2970 Hoersholm,




Denmark






Targocid


400 mg


powder for solution for injection


intramuscular use/intravenous use


400 mg/3 ml




Finland







sanofi-aventis Oy




Huopalahdentie 24




PL 22




00351 Helsinki,




Finland






Targocid 200 mg injektio- ja infuusiokuiva-aine, liuosta varten


200 mg


powder for solution for injection/ infusion


intramuscular use/intravenous use


200 mg/3 ml




Finland







sanofi-aventis Oy




Huopalahdentie 24




PL 22




00351 Helsinki,




Finland






Targocid 400 mg injektio- ja infuusiokuiva-aine, liuosta varten


400 mg


powder for solution for injection/ infusion


intramuscular use/intravenous use


400 mg/3 ml




France







sanofi-aventis France




1-13 Bd Romain Rolland




75014 Paris,




France






TARGOCID 100 mg, lyophilisat et solution pour usage parentéral


100 mg


powder and solvent for injection


intramuscular use/intravenous use


100 mg/1.5 ml




France







sanofi-aventis France




1-13 Bd Romain Rolland




75014 Paris,




France






TARGOCID 200 mg, lyophilisat et solution pour usage parentéral


200 mg


powder and solvent for injection


intramuscular use/intravenous use


200 mg/3 ml




France







sanofi-aventis France




1-13 Bd Romain Rolland




75014 Paris,




France






TARGOCID 400 mg, lyophilisat et solution pour usage parentéral


400 mg


powder and solvent for injection


intramuscular use/intravenous use


400 mg/3 ml




Germany







sanofi-aventis Deutschland GmbH




Industriepark Höchst, Geb. K 703,




65926 Frankfurt am Main,




Deutschland






Targocid® 100 mg


100 mg


powder and solvent for solution for infusion/injection or oral solution


intramuscular use/intravenous use, oral use


100 mg/1.5 ml




Germany







sanofi-aventis Deutschland GmbH




Industriepark Höchst, Geb. K 703,




65926 Frankfurt am Main,




Deutschland






Targocid® 200 mg


200 mg


powder and solvent for solution for infusion/injection or oral solution


intramuscular use/intravenous use, oral use


200 mg/3 ml




Germany







sanofi-aventis Deutschland GmbH




Industriepark Höchst, Geb. K 703,




65926 Frankfurt am Main,




Deutschland






Targocid® 400 mg


400 mg


powder and solvent for solution for infusion/injection or oral solution


intramuscular use/intravenous use, oral use


400 mg/3 ml




Germany







sanofi-aventis Deutschland GmbH




Industriepark Höchst, Geb. K 703,




65926 Frankfurt am Main,




Deutschland






Teicoplanin Sanofi-Aventis 100 mg


100 mg


powder and solvent for solution for infusion/injection or oral solution


intramuscular use/intravenous use, oral use


100 mg/1.5 ml




Germany







sanofi-aventis Deutschland GmbH




Industriepark Höchst, Geb. K 703,




65926 Frankfurt am Main,




Deutschland






Teicoplanin Sanofi-Aventis 200 mg


200 mg


powder and solvent for solution for infusion/injection or oral solution


intramuscular use/intravenous use, oral use


200 mg/3 ml




Germany







sanofi-aventis Deutschland GmbH




Industriepark Höchst, Geb. K 703,




65926 Frankfurt am Main,




Deutschland






Teicoplanin Sanofi-Aventis 400 mg


400 mg


powder and solvent for solution for infusion/injection or oral solution


intramuscular use/intravenous use, oral use


400 mg/3 ml




Greece







Vianex S.A.




Tatoiou Street




14671 Nea Erythrea,




Greece






TARGOCID®



200 mg


Powder and solvent for injection or infusion


intramuscular use/intravenous use


200 mg/3 ml




Greece







Vianex S.A.




Tatoiou Street




14671 Nea Erythrea,




Greece






TARGOCID®



400mg


Powder and solvent for injection or infusion


intramuscular use/intravenous use


400 mg/3 ml




Hungary







sanofi-aventis Zrt.




1-5. Tó u.,




1045 Budapest,




Hungary






Targocid 200 mg por és oldószer oldatos injekcióhoz


200 mg


powder and solvent for solution for injection


intramuscular use/intravenous use


200 mg/3 ml




Hungary







sanofi-aventis Zrt.




1-5. Tó u.,




1045 Budapest,




Hungary






Targocid 400 mg por és oldószer oldatos injekcióhoz


400 mg


powder and solvent for solution for injection


intramuscular use/intravenous use


400 mg/3 ml




Ireland







sanofi-aventis Ireland Ltd., T/A Sanofi




18 Riverwalk




Citywest Business Campus, Dublin 24,




Ireland






Targocid 200mg Powder and Solvent for Solution for Injection


200 mg


powder and solvent for solution for injection


intramuscular use/intravenous use


200 mg/3 ml




Ireland







sanofi-aventis Ireland Ltd., T/A Sanofi




18 Riverwalk




Citywest Business Campus, Dublin 24,




Ireland






Targocid 400mg Powder and Solvent for Solution for Injection


400 mg


powder and solvent for solution for injection


intramuscular use/intravenous use


400 mg/3 ml




Italy







sanofi-aventis SPA




Viale L. Bodio, 37/B –




20158 Milano,




Italy






TARGOSID


200 mg


powder and solvent for solution for injection


intramuscular use/intravenous use


200 mg/3 ml




Italy







sanofi-aventis SPA




Viale L. Bodio, 37/B –




20158 Milano,




Italy






TARGOSID


400 mg


powder and solvent for solution for injection


intramuscular use/intravenous use


400 mg/3 ml




Italy







sanofi-aventis SPA




Viale L. Bodio, 37/B –




20158 Milano,




Italy






TEICOMID


200 mg


powder and solvent for solution for injection


intramuscular use/intravenous use


200 mg/3 ml




Italy







sanofi-aventis SPA




Viale L. Bodio, 37/B –




20158 Milano,




Italy






TEICOMID


400 mg


powder and solvent for solution for injection


intramuscular use/intravenous use


400 mg/3 ml




Luxembourg







sanofi-aventis Belgium




Culliganlaan 1C




1831 Diegem,




Belgium






TARGOCID


200 mg


powder for injectable preparations


intramuscular use/intravenous use


200 mg/3 ml




Luxembourg







sanofi-aventis Belgium




Culliganlaan 1C




1831 Diegem,




Belgium






TARGOCID


400 mg


powder for injectable preparations


intramuscular use/intravenous use


400 mg/3 ml




Malta







Sanofi-Aventis Malta Ltd.




Triq Kan. K. Pirotta,




Birkirkara BKR1114,




Malta






Targocid® 200 mg


200 mg


powder and solvent for solution for injection


intramuscular use/intravenous use


200 mg/3 ml




Netherlands







sanofi-aventis Netherlands BV.




Kampenringweg 45 D-E,




2803 PE Gouda,




The Netherlands






TARGOCID® 200


200 mg


powder for solution for injection


intramuscular use/intravenous use


200 mg/3 ml




Netherlands







sanofi-aventis Netherlands BV.




Kampenringweg 45 D-E,




2803 PE Gouda,




The Netherlands






TARGOCID® 400


400 mg


powder for solution for injection


intramuscular use/intravenous use


400 mg/3 ml




Norway







sanofi-aventis Norge AS,




Strandveien 15,




PO Box 133, 1325 Lysaker,




Norway






TARGOCID®



400 mg


powder for solution for injection/infusion


intramuscular use/intravenous use


400 mg/3 ml




Poland







Aventis Pharma Ltd.




One Onslow Street,




Guildford, Surrey




GU1 4YS,




United Kingdom






TARGOCID


200 mg


powder and solvent for solution for injection and infusion


intramuscular use/intravenous use


200 mg/3 ml




Poland







Aventis Pharma Ltd.




One Onslow Street,




Guildford, Surrey




GU1 4YS,




United Kingdom






TARGOCID


400 mg


powder and solvent for solution for injection and infusion


intramuscular use/intravenous use


400 mg/3 ml




Portugal







Sanofi - Produtos Farmacêuticos, Lda.




Empreendimento Lagoas Park




Edifício 7 – 3o Piso




2740-244 Porto Salvo




Portugal






Targosid


200 mg/3 ml


powder and solvent for solution for injection or for infusion


intramuscular use/intravenous use


200 mg/3 ml




Portugal







Sanofi - Produtos Farmacêuticos, Lda.




Empreendimento Lagoas Park




Edifício 7 – 3o Piso




2740-244 Porto Salvo




Portugal






Targosid


400 mg/3 ml


powder and solvent for solution for injection or for infusion


intramuscular use/intravenous use


400 mg/3 ml




Romania







Aventis Pharma Ltd.




Trading as sanofi-aventis or Sanofi




One Onslow Street,




Guildford Surrey,




GU1 4YS,




United Kingdom






TARGOCID® 200 mg


200 mg


powder and solvent for solution for injection


intramuscular use/intravenous use


200 mg/3 ml




Romania







Aventis Pharma Ltd.




Trading as sanofi-aventis or Sanofi




One Onslow Street,




Guildford Surrey,




GU1 4YS,




United Kingdom






TARGOCID® 400 mg


400 mg


powder and solvent for solution for injection


intramuscular use/intravenous use


400 mg/3 ml




Slovak Republic







sanofi-aventis Pharma




Slovakia s.r.o Einsteinova 24,




85101 Bratislava,




Slovak Republic






Targocid 200


200 mg


powder and solvent for solution for injection or infusion


intramuscular use/intravenous use, oral use


200 mg/3 ml




Slovak Republic







sanofi-aventis Pharma




Slovakia s.r.o Einsteinova 24,




85101 Bratislava,




Slovak Republic






Targocid 400


400 mg


powder and solvent for solution for injection or infusion


intramuscular use/intravenous use, oral use


400 mg/3 ml




Slovenia







sanofi-aventis d.o.o.




Dunajska cesta 151




1000 Ljubljana




Slovenia






Targocid 200 mg prašek in vehikel za raztopino za injiciranje ali infundiranje


200 mg


powder and solvent for solution for injection or infusion


intramuscular use/intravenous use


200 mg/3 ml




Slovenia







sanofi-aventis d.o.o.




Dunajska cesta 151




1000 Ljubljana




Slovenia






Targocid 400 mg prašek in vehikel za raztopino za injiciranje ali infundiranje


400 mg


powder and solvent for solution for injection or infusion


intramuscular use/intravenous use


400 mg/3 ml




Spain







Marion Merrell S.A.




Martínez Villergas, 52




28027 Madrid




Spain






TARGOCID


200 mg


powder and solvent for solution for injection or infusion


intramuscular use/intravenous use


200 mg/3 ml




Spain







Marion Merrell S.A.




Martínez Villergas, 52




28027 Madrid




Spain






TARGOCID


400 mg


powder and solvent for solution for injection or infusion


intramuscular use/intravenous use


400 mg/3 ml




Sweden







sanofi-aventis AB




Box 14142




167 14 Bromma,




Sweden






Targocid


200 mg


Powder for injection-/infusion, solution


intramuscular use/intravenous use


200 mg/3 ml




Sweden







sanofi-aventis AB




Box 14142




167 14 Bromma,




Sweden






Targocid


400 mg


Powder for injection-/infusion, solution


intramuscular use/intravenous use


400 mg/3 ml




United Kingdom







Aventis Pharma Ltd. (or trading as Marion Merrell or Aventis Pharma)




One Onslow Street




Guildford




Surrey




GU1 4YS




United Kingdom




or trading as





Sanofi-aventis or Sanofi




One Onslow Street




Guildford




Surrey




GU1 4YS




United Kingdom






TARGOCID®



200 mg


powder for injection


intramuscular use/intravenous use


200 mg/3 ml




United Kingdom







Aventis Pharma Ltd. (or trading as Marion Merrell or Aventis Pharma)




One Onslow Street




Guildford




Surrey




GU1 4YS




United Kingdom




or trading as





Sanofi-aventis or Sanofi




One Onslow Street




Guildford




Surrey




GU1 4YS




United Kingdom






TARGOCID®



400 mg


powder for injection


intramuscular use/intravenous use


400 mg/3 ml







ANNEX VII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES











Member State
(in EEA)


Marketing authorisation holder


Product name


Strength


Pharmaceutical form


Route of administration




Bulgaria







Zentiva k.s.




130 U kabelovn




Prague 10237




Czech Republic






Flupizen


100 mg


capsule, hard


oral use




Estonia







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




The Netherlands






KATADOLON


100 mg


capsule, hard


oral use




Germany







AbZ-Pharma GmbH




Graf-Arco-Str. 3




89079 Ulm




Germany






Flupirtinmaleat AbZ 100 mg Kapseln


100 mg


capsule, hard


oral use




Germany







Aliud Pharma GmbH




Gottlieb-Daimler-Str. 19




89150 Laichingen




Germany






Flupirtinmaleat AL 100 mg Hartkapseln


100 mg


capsule, hard


oral use




Germany







AWD.pharma GmbH & Co. KG




Wasastr. 50




01445 Radebeul




Germany






Awegal inject


164,5 mg / 3 ml


solution for injection


intramuscular use




Germany







AWD.pharma GmbH & Co. KG




Wasastr. 50




01445 Radebeul




Germany






Katadolon inject


164,5 mg / 3 ml


solution for injection


intramuscular use




Germany







AWD.pharma GmbH & Co. KG




Wasastr. 50




01445 Radebeul




Germany






Katadolon Kinderzäpfchen


75 mg


suppository


rectal use




Germany







AWD.pharma GmbH & Co. KG




Wasastr. 50




01445 Radebeul




Germany






Katadolon Zäpfchen


150 mg


suppository


rectal use




Germany







AWD.pharma GmbH & Co. KG




Wasastr. 50




01445 Radebeul




Germany






Trancopal Dolo


100 mg


capsule


oral use




Germany







AWD.pharma GmbH & Co. KG




Wasastr. 50




01445 Radebeul




Germany






Trancopal Dolo Suppositorien


150 mg


suppository


rectal use




Germany







AWD.pharma GmbH & Co. KG




Wasastr. 50




01445 Radebeul




Germany






Katadolon S long


400 mg


prolonged release tablet


oral use




Germany







AWD.pharma GmbH & Co. KG




Wasastr. 50




01445 Radebeul




Germany






Katadolon


100 mg


capsule, hard


oral use




Germany







AWD.pharma GmbH & Co. KG




Wasastr. 50




01445 Radebeul




Germany






Trancolong


400 mg


prolonged release tablet


oral use




Germany







AWD.pharma GmbH & Co. KG




Wasastr. 50




01445 Radebeul




Germany






Katadolon retard


400 mg


prolonged release tablet


oral use




Germany







AWD.pharma GmbH & Co. KG




Wasastr. 50




01445 Radebeul




Germany






Flupirtinmaleat Winthrop 400 mg Retardtabletten


400 mg


prolonged release tablet


oral use




Germany







CT Arzneimittel GmmbH




Graf-Arco-Str. 3




89079 Ulm




Germany






Flupirtinmaleat-CT 100 mg Hartkapsel


100 mg


capsule, hard


oral use




Germany







CT Arzneimittel GmmbH




Graf-Arco-Str. 3




89079 Ulm




Germany






Flupin 100 mg Hartkapseln


100 mg


capsule, hard


oral use




Germany







Dr. Kade Pharmazeutische Fabrik GmbH




Rigistr. 2




12277 Berlin




Germany






Dolokadin einmal täglich


400 mg


prolonged release tablet


oral use




Germany







Hormosan Pharma GmbH




Wilhelmshöher Str. 106




60389 Frankfurt




Germany






Flupigamma 100 mg Hartkapseln


100 mg


capsule, hard


oral use




Germany







Hormosan Pharma GmbH




Wilhelmshöher Str. 106




60389 Frankfurt




Germany






Flupirtinmaleat-Hormosan 100 mg Hartkapseln


100 mg


capsule, hard


oral use




Germany







MEDA Pharma GmbH & Co. KG




Benzstr. 1




61352 Bad Homburg




Germany






Flupigil 100 mg Hartkapseln


100 mg


capsule, hard


oral use




Germany







MEDA Pharma GmbH & Co. KG




Benzstr. 1




61352 Bad Homburg




Germany






Flupigil 100 mg Hartkapseln


100 mg


capsule, hard


oral use




Germany







Midas Pharma GmbH




Rheinstr. 49




55218 Ingelheim




Germany






Flupirtinmaleat Midas 100 mg Hartkapseln


100 mg


capsule, hard


oral use




Germany







ratiopharm GmbH




Graf-Arco-Str. 3




89079 Ulm




Germany






Flupirtinmaleat-ratiopharm 100 mg Hartkapsel


100 mg


capsule, hard


oral use




Germany







ratiopharm GmbH




Graf-Arco-Str. 3




89079 Ulm




Germany






Miflumal 100 mg Hartkapseln


100 mg


capsule, hard


oral use




Germany







Vitapharma Generics GmbH




Benzstr. 1




61352 Bad Homburg v. d. H.




Germany






Flupirtinmaleat Vitapharma 100 mg Hartkapseln


100 mg


capsule, hard


oral use




Germany







Vitapharma Generics GmbH




Benzstr. 1




61352 Bad Homburg v. d. H.




Germany






Flupivil 100 mg Hartkapseln


100 mg


capsule, hard


oral use




Germany







Vitapharma Generics GmbH




Benzstr. 1




61352 Bad Homburg v. d. H.




Germany






Flupirtinmaleat Viatris 100 mg Hartkapseln


100 mg


capsule, hard


oral use




Germany







Winthrop Arzneimittel GmbH




Brüningstr. 50




65926 Frankfurt am Main




Germany






Flupirtinmaleat Winthrop 100 mg Hartkapseln


100 mg


capsule, hard


oral use




Germany







Winthrop Arzneimittel GmbH




Brüningstr. 50




65926 Frankfurt am Main




Germany






Flupimal 100 mg Hertkapseln


100 mg


capsule, hard


oral use




Germany







Winthrop Arzneimittel GmbH




Brüningstr. 50




65926 Frankfurt am Main




Germany






Flupsadim 100 mg Hartkapseln


100 mg


capsule, hard


oral use




Germany







Winthrop Arzneimittel GmbH




Brüningstr. 50




65926 Frankfurt am Main




Germany






Miphaflumix 100 mg Hartkapseln


100 mg


capsule, hard


oral use




Germany







Winthrop Arzneimittel GmbH




Brüningstr. 50




65926 Frankfurt am Main




Germany






Fluporol 100 mg Hartkapseln


100 mg


capsule, hard


oral use




Germany







Winthrop Arzneimittel GmbH




Brüningstr. 50




65926 Frankfurt am Main




Germany






Flupirtinmaleat Winthrop 100 mg Hartkapseln


100 mg


capsule, hard


oral use




Hungary







ZENTIVA k.s.




Ul. kabelovny 130, Dolní Mecholupy




10237 Prague 10




Czeh Republic






Flupizen 100 mg kemény kapszula


100 mg


capsule, hard


oral use




Italy







MEDA PHARMA S.p.A.,




Viale Brenta 18, 20139 Milano




Italy






EFIRET


100 mg


capsule, hard


oral use




Latvia







Teva Pharma B.V.,




Computerweg 10,




3542 DR Utrecht




The Netherlands






Katadolon 100 mg hard capsules


100 mg


capsule, hard


oral use




Lithuania







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




The Netherlands






Katadolon


100 mg


capsule, hard


oral use




Poland







Teva Pharmaceuticals Polska Sp. z o.o.




ul. Emilii Plater 53




00-113 Warsaw




Poland






Katadolon


100 mg


capsule, hard


oral use




Portugal







Midas Pharma GmbH




Rheinstrasse, 49




55218 Ingelheim




Germany






Flupirtina Midas


100 mg


capsule, hard


oral use




Portugal







Sanofi-Aventis - Produtos Farmacêuticos, Lda.




Empreendimento Lagoas Park,




Edifício 7 - 3o Piso




2740-244 Porto Salvo




Portugal






Flupirtina Winthrop


100 mg


capsule, hard


oral use




Portugal







Meda Pharma - Produtos Farmacêuticos, S.A.




Rua do Centro Cultural, 13




1749-066 Lisboa




Portugal






Metanor


100 mg


capsule, hard


oral use




Romania







Zentiva k.s.




U Kabelovny 130, Dolní Měcholupy




102 37, Praga 10,




Czech Republic






FLUPIZEN 100 mg


100 mg


capsule


oral use




Slovak Republic







Zentiva k.s.




U Kabelovny 130




102 37 Praha 10




Czech Republic






Flupizen 100 mg tvrdé kapsuly


100 mg


capsule, hard


oral use




Slovak Republic







TEVA Pharmaceuticals Slovakia, s.r.o.




Teslova 26




821 02 Bratislava




Slovak Republic






Katadolon


100 mg


capsule, hard


oral use







ANNEX VIII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES













Member State EU/EEA


Applicant/marketing authorisation holder


Name


INN


Strength


Pharmaceutical form


Route of administration


Animal species




Austria







Pfizer Corporation Austria Gesellschaft m.b.H.




Floridsdorfer Hauptstraße 1,




1210 Wien




AUSTRIA






Dectomax 1 % - Injektionslösung für Rinder und Schafe


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep




Austria







Pfizer Corporation Austria Gesellschaft m.b.H.




Floridsdorfer Hauptstraße 1,




1210 Wien




AUSTRIA






Dectomax S 10 mg/ml Injektionslösung für Schweine


Doramectin


10 mg/ml


Solution for injection


intramuscular


Pigs




Austria







Pfizer Corporation Austria Gesellschaft m.b.H.




Floridsdorfer Hauptstraße 1,




1210 Wien




AUSTRIA






Dectomax Pour-On 5 mg/ml Lösung für Rinder


Doramectin


5 mg/ml


Pour-on solution


topical - on the back of the animal


Cattle




Belgium







Eli Lilly Benelux S.A.




Division Elanco Animal Health




Stoofstraat 52




1000 Brussel




BELGIUM






DECTOMAX


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep




Belgium







Eli Lilly Benelux S.A.




Division Elanco Animal Health




Stoofstraat 52




1000 Brussel




BELGIUM






DECTOMAX POUR-ON


Doramectin


5 mg/ml


Pour-on solution


topical - on the back of the animal


Cattle




Belgium







Eli Lilly Benelux S.A.




Division Elanco Animal Health




Stoofstraat 52




1000 Brussel




BELGIUM






DECTOMAX SOLUTION INJECTABLE POUR PORCS


Doramectin


10 mg/ml


Solution for injection


intramuscular


Pigs




Bulgaria







Pfizer S.A.,




Z.l. De Poce-sur-Cisse, B.P. 109




37401 Amboise Cedex,




FRANCE






Дектомакс 1 % инжективен разтвор


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Bulgaria







BIOVET AD




39 Petar Rakov str.




Peshtera 4550




BULGARIA






Ендектовет 1 % инжекционен разтвор за говеда, овце и свине


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Cyprus







PFIZER HELLAS AE




243 Av Mesogeion




15451, Athens




GREECE






DECTOMAX 1 % ενέσιμο διάλυμα για βοοειδή, χοίρους και πρόβατα


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Czech republic







Pfizer s.r.o.




Stroupežnického 17




150 00 Praha




CZECH REPUBLIC






DECTOMAX 10 mg/ml injekční roztok


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Czech republic







Pfizer Limited




Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




UNITED KINGDOM






Prontax 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Denmark







Pfizer Oy, Animal Health,




Tietokuja 4




00330 Helsinki




FINLAND






Dectomax Pour-On Vet.


Doramectin


5 mg/ml


Pour-on solution


topical - on the back of the animal


Cattle




Denmark







Pfizer Oy, Animal Health,




Tietokuja 4




00330 Helsinki




FINLAND






Dectomax Vet.


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, pigs




Denmark







Pfizer Oy, Animal Health,




Tietokuja 4




00330 Helsinki




FINLAND






Prontax


Doramectin


5 mg/ml


Pour-on solution


topical - on the back of the animal


Cattle




Denmark







Pfizer Oy, Animal Health,




Tietokuja 4




00330 Helsinki




FINLAND






Prontax


Doramectin


10 mg/ml


Solution for injection


subcutaneous


Cattle




Estonia







Pfizer Animal Health S.A.,




Rue Laid Burniat 1,




1348 Louvain-la-Neuve,




BELGIUM






Dectomax


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Estonia







Pfizer Limited




Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




UNITED KINGDOM






Prontax 10 mg/ml Solution for injection for Cattle, Sheep and Pigs


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Finland







Pfizer Oy, Animal Health,




Tietokuja 4




00330 Helsinki




FINLAND






DECTOMAX vet 10 mg/ml injektioneste, liuos


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, reindeer, pigs




Finland







Pfizer Oy, Animal Health,




Tietokuja 4




00330 Helsinki




FINLAND






Prontax 5 mg/ml kertavaleluliuos


Doramectin


5 mg/ml


Pour-on solution


topical - on the back of the animal


Cattle




Finland







Pfizer Oy, Animal Health,




Tietokuja 4




00330 Helsinki




FINLAND






Prontax 10 mg/ml injektioneste, liuos


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




France







Lilly France




13 Rue Pages




92158 Suresnes Cedex




FRANCE






ZEARL


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep




France







Lilly France




13 Rue Pages




92158 Suresnes Cedex




FRANCE






ZEARL POUR ON


Doramectin


5 mg/ml


Pour-on solution


topical - on the back of the animal


Cattle




France







Lilly France




13 Rue Pages




92158 Suresnes Cedex




FRANCE






ZEARL PORCS


Doramectin


10 mg/ml


Solution for injection


intramuscular


Pigs




France







Pfizer Limited




Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




UNITED KINGDOM






PRONTAX 5 MG/ML SOLUTION POUR POUR ON POUR BOVINS


Doramectin


5 mg/ml


Pour-on solution


topical - on the back of the animal


Cattle




France







Pfizer Limited




Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




UNITED KINGDOM






PRONTAX 10 MG/ML SOLUTION INJECTABLE POUR BOVINS OVINS ET PORCINS


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Germany







Lilly Deutschland GmbH




Teichweg 3




35396 Gießen




GERMANY






Dectomax


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep




Germany







Lilly Deutschland GmbH




Teichweg 3




35396 Gießen




GERMANY






Dectomax Pour-On


Doramectin


5 mg/ml


Pour-on solution


topical - on the back of the animal


Cattle




Germany







Lilly Deutschland GmbH




Teichweg 3




35396 Gießen




GERMANY






Dectomax-S Injektionslösung


Doramectin


10 mg/ml


Solution for injection


intramuscular


Pigs




Greece







PFIZER HELLAS AE




243 Av Mesogeion




15451, Athens




GREECE






DECTOMAX ing sol


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Hungary







Pfizer Kft.




Alkotás u. 53.




1123 Budapest




HUNGARY






Dectomax injekció A.U.V.


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Iceland







Pfizer Oy, Animal Health,




Tietokuja 4




00330 Helsinki




FINLAND






Dectomax, vet.


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Iceland







Pfizer Oy, Animal Health,




Tietokuja 4




00330 Helsinki




FINLAND






Prontax


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Iceland







Pfizer Oy, Animal Health,




Tietokuja 4




00330 Helsinki




FINLAND






Prontax


Doramectin


5 mg/ml


Pour-on solution


topical - on the back of the animal


Cattle




Ireland







Elanco Animal Health




Eli Lilly & Company Limited




Lilly House




Priestly Road




Basingstoke, Hampshire




RG24 9NL




UNITED KINGDOM






Zearl Pour-On Solution for Cattle 5 mg/ml


Doramectin


5 mg/ml


Pour-on solution


topical - on the back of the animal


Cattle




Ireland







Elanco Animal Health




Eli Lilly & Company Limited




Lilly House




Priestly Road




Basingstoke, Hampshire




RG24 9NL




UNITED KINGDOM






Zearl 10 mg/ml Solution for Injection for Cattle and Sheep


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep




Ireland







Elanco Animal Health




Eli Lilly & Company Limited




Lilly House




Priestly Road




Basingstoke, Hampshire




RG24 9NL




UNITED KINGDOM






Zearl 10 mg/ml Solution for Injection for Pigs


Doramectin


10 mg/ml


Solution for injection


intramuscular


Pigs




Ireland







Pfizer Limited




Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




UNITED KINGDOM






Dectomax 5 mg/ml Pour-On Solution for Cattle


Doramectin


5 mg/ml


Pour-on solution


topical - on the back of the animal


Cattle




Ireland







Pfizer Limited




Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




UNITED KINGDOM






DECTOMAX 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Italy







Pfizer Italia S.r.l.




Via Isonzo, 71




04100 Latina




ITALY






DECTOMAX 10 mg/ml soluzione iniettabile per bovini, ovini e suini


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Italy







Pfizer Italia S.r.l.




Via Isonzo, 71




04100 Latina




ITALY






DECTOMAX POUR ON 5 mg/ml


Doramectin


5 mg/ml


Pour-on solution


topical - on the back of the animal


Cattle




Latvia







Pfizer Animal Health S.A.,




Rue Laid Burniat, 1,




1348 Louvain-la-Neuve,




BELGIUM






Dectomax


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Latvia







Pfizer Limited




Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




UNITED KINGDOM






Dectomax


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Lithuania







Pfizer S.A.,




Z.l. De Poce-sur-Cisse, B.P. 109




37401 Amboise Cedex,




FRANCE






DECTOMAX, injekcinis tirpalas galvijams, avims ir kiaulėms


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Lithuania







Pfizer Limited




Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




UNITED KINGDOM






PRONTAX 10 mg/ml, injekcinis tirpalas galvijams, avims ir kiaulėms


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




The Netherlands







Pfizer Animal Health B.V.




Rivium Westlaan 142




2909 LD Capelle a/d IJssel




THE NETHERLANDS






Dectomax Pour-On Oplossing voor Rundvee 5 mg/ml


Doramectin


5 mg/ml


Pour-on solution


topical - on the back of the animal


Cattle




The Netherlands







Pfizer Animal Health B.V.




Rivium Westlaan 142




2909 LD Capelle a/d IJssel




THE NETHERLANDS






DECTOMAX oplossing voor injectie 10 mg/ml voor rundvee, varkens en schapen


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Norway







Pfizer Oy, Animal Health,




Tietokuja 4




00330 Helsinki




FINLAND






Dectomax Pour-On vet


Doramectin


5 mg/ml


Pour-on solution


topical - on the back of the animal


Cattle




Norway







Pfizer Oy, Animal Health,




Tietokuja 4




00330 Helsinki




FINLAND






Dectomax vet


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Norway







Pfizer Oy, Animal Health,




Tietokuja 4




00330 Helsinki




FINLAND






Prontax


Doramectin


5 mg/ml


Pour-on solution


topical - on the back of the animal


Cattle




Norway







Pfizer Oy, Animal Health,




Tietokuja 4




00330 Helsinki




FINLAND






Prontax


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Poland







Pfizer Trading Polska s.p. z o.o.




ul. Postępu 17 B




02-676 Warszawa




POLAND






Dectomax 10 mg/ml, roztwór do wstrzykiwań dla bydła, świń i owiec


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Portugal







LABORATÓRIOS PFIZER, LDA.




Lagoas Park - Edifício 10




2740-244 Porto Salvo




PORTUGAL






Dectomax Pour-on


Doramectin


5 mg/ml


Pour-on solution


topical - on the back of the animal


Cattle




Portugal







LABORATÓRIOS PFIZER, LDA.




Lagoas Park - Edifício 10




2740-244 Porto Salvo




PORTUGAL






Dectomax solução injectável


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Romania







Pfizer Limited




Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




UNITED KINGDOM






DECTOMAX


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Romania







Pfizer Limited




Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




UNITED KINGDOM






PRONTAX 10 mg/ml Injectable Solution for Cattle, Sheep and Pigs


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Romania







Pfizer Limited




Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




UNITED KINGDOM






PRONTAX 5 mg/ml Pour On Solution for Cattle


Doramectin


5 mg/ml


Pour-on solution


topical - on the back of the animal


Cattle




Slovakia







Pfizer Luxemburg SARL, o.z.




Pfizer AH




Pribinova 25




811 09 Bratislava




SLOVAK REPUBLIC






Dectomax 10 mg/ml injekčný roztok


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Slovenia







Pfizer Luxembourg SARL




51, Avenue J.F. Kennedy




L-1855 Luxembourg




LUXEMBOURG






DECTOMAX 10 mg/ml raztopina za injiciranje


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Spain







PFIZER S.A.




Avda. de Europa 20 B.




Parque Empresarial La Moraleja




28108 - Alcobendas




Madrid




SPAIN






DECTOMAX 10 MG/ML SOLUCIÓN INYECTABLE PARA PORCINO


Doramectin


10 mg/ml


Solution for injection


intramuscular


Pigs




Spain







PFIZER S.A.




Avda. de Europa 20 B.




Parque Empresarial La Moraleja




28108 - Alcobendas




Madrid




SPAIN






DECTOMAX POUR-ON SOLUCION 5 MG/ML PARA BOVINO


Doramectin


5 mg/ml


Pour-on solution


topical - on the back of the animal


Cattle




Spain







PFIZER S.A.




Avda. de Europa 20 B.




Parque Empresarial La Moraleja




28108 - Alcobendas




Madrid




SPAIN






DECTOMAX SOLUCION INYECTABLE


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep




Sweden







Pfizer Oy, Animal Health,




Tietokuja 4




00330 Helsinki




FINLAND






Dectomax vet.


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, reindeer




Sweden







Pfizer Oy, Animal Health,




Tietokuja 4




00330 Helsinki




FINLAND






Dectomax Suis vet.


Doramectin


10 mg/ml


Solution for injection


intramuscular


Pigs




Sweden







Pfizer Oy, Animal Health,




Tietokuja 4




00330 Helsinki




FINLAND






Prontax


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep, pigs




Sweden







Pfizer Oy, Animal Health,




Tietokuja 4




00330 Helsinki




FINLAND






Dectomax pour-on vet.


Doramectin


5 mg/ml


Pour-on solution


topical - on the back of the animal


Cattle




Sweden







Pfizer Oy, Animal Health,




Tietokuja 4




00330 Helsinki




FINLAND






Prontax


Doramectin


5 mg/ml


Pour-on solution


topical - on the back of the animal


Cattle




United Kingdom







Elanco Animal Health




Eli Lilly & Company Limited




Lilly House




Priestly Road




Basingstoke, Hampshire




RG24 9NL




UNITED KINGDOM






Dectomax 10 mg/ml Solution for Injection for Cattle and Sheep


Doramectin


10 mg/ml


Solution for injection


subcutaneous, intramuscular


Cattle, sheep




United Kingdom







Elanco Animal Health




Eli Lilly & Company Limited




Lilly House




Priestly Road




Basingstoke, Hampshire




RG24 9NL




UNITED KINGDOM






Dectomax 10 mg/ml Solution for Injection for Pigs


Doramectin


10 mg/ml


Solution for injection


intramuscular


Pigs




United Kingdom







Elanco Animal Health




Eli Lilly & Company Limited




Lilly House




Priestly Road




Basingstoke, Hampshire




RG24 9NL




UNITED KINGDOM






Dectomax Pour-on Solution for Cattle 5 mg/ml


Doramectin


5 mg/ml


Pour-on solution


topical - on the back of the animal


Cattle







ANNEX IX

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES












Member State
(in EEA)


Marketing authorisation holder


INN


Invented name


Strengths


Pharmaceutical forms


Routes of administration




Austria







Pfizer Corporation Austria Ges.m.b.H




Floridsdorfer Hauptstraße 1,




1210 Vienna




Austria






Diclofenac sodium
Misoprostol


Arthrotec forte - Manteltabletten


75 mg
0,2 mg


Coated tablet


Oral use




Austria







Pfizer Corporation Austria Ges.m.b.H




Floridsdorfer Hauptstraße 1,




1210 Vienna




Austria






Diclofenac sodium
Misoprostol


Arthrotec - Manteltabletten


50 mg
0,2 mg


Coated tablet


Oral use




Austria







Astellas Pharma GmbH




Linzer Straße 221/E02




1140 Vienna




Austria






Diclofenac sodium


Dedolor akut 75 mg – Kapseln


75 mg


Gastro-resistant capsule, hard


Oral use




Austria







Astellas Pharma GmbH




Linzer Straße 221/E02




1140 Vienna




Austria






Diclofenac sodium


Dedolor DRS 100 mg – Kapseln


100 mg


Capsule, hard


Oral use




Austria







Astellas Pharma GmbH




Linzer Straße 221/E02




1140 Vienna




Austria






Diclofenac sodium


Deflamat DRS 75 mg – Kapseln


75 mg


Capsule, hard


Oral use




Austria







Astellas Pharma GmbH




Linzer Straße 221/E02




1140 Vienna




Austria






Diclofenac sodium


Deflamat 75 mg - Ampullen


75 mg/3 ml


Solution for injection/infusion


Intramuscular use, Intravenous use




Austria







Astellas Pharma GmbH




Linzer Straße 221/E02




1140 Vienna




Austria






Diclofenac sodium


Deflamat 50 mg – Kapseln


50 mg


Capsule, hard


Oral use




Austria







Astellas Pharma GmbH




Linzer Straße 221/E02




1140 Vienna




Austria






Diclofenac sodium


Deflamat 100 mg – Suppositorien


100 mg


Suppository


Rectal use




Austria







Astellas Pharma GmbH




Linzer Straße 221/E02




1140 Vienna




Austria






Diclofenac sodium


Deflamat retard 100 mg – Kapseln


100 mg


Capsule, hard


Oral use




Austria







Hexal Pharma GmbH




Stella-Klein-Löw-Weg 17




1020 Vienna




Austria






Diclofenac sodium


DiclacHexal 50 mg - Filmtabletten


50 mg


Film-coated tablet


Oral use




Austria







Hexal Pharma GmbH




Stella-Klein-Löw-Weg 17




1020 Vienna




Austria






Diclofenac sodium


DiclacHexal rapid 50 mg - lösbare Tabletten


50 mg


Soluble tablet


Oral use




Austria







Hexal Pharma GmbH




Stella-Klein-Löw-Weg 17




1020 Vienna




Austria






Diclofenac sodium


DiclacHexal retard 150 mg - Tabletten


150 mg


Prolonged-release tablet


Oral use




Austria







Hexal Pharma GmbH




Stella-Klein-Löw-Weg 17




1020 Vienna




Austria






Diclofenac sodium


DiclacHexal retard 75 mg - Tabletten


75 mg


Prolonged-release tablet


Oral use




Austria







ratiopharm Arzneimittel VertriebsGmbH




Albert-Schweitzer-Gasse 3




1140 Vienna




Austria






Diclofenac sodium


Diclobene 75 mg – Ampullen


75 mg/2 ml


Solution for injection/infusion


Intramuscular use, Intravenous use




Austria







ratiopharm Arzneimittel VertriebsGmbH




Albert-Schweitzer-Gasse 3




1140 Vienna




Austria






Diclofenac sodium


Diclobene 25 mg – Filmtabletten


25 mg


Film-coated tablet


Oral use




Austria







ratiopharm Arzneimittel VertriebsGmbH




Albert-Schweitzer-Gasse 3




1140 Vienna




Austria






Diclofenac sodium


Diclobene 50 mg – Filmtabletten


50 mg


Film-coated tablet


Oral use




Austria







ratiopharm Arzneimittel VertriebsGmbH




Albert-Schweitzer-Gasse 3




1140 Vienna




Austria






Diclofenac sodium


Diclobene 100 mg – Zäpfchen


100 mg


Suppository


Rectal use




Austria







ratiopharm Arzneimittel VertriebsGmbH




Albert-Schweitzer-Gasse 3




1140 Vienna




Austria






Diclofenac sodium


Diclobene 50 mg – Zäpfchen


50 mg


Suppository


Rectal use




Austria







ratiopharm Arzneimittel VertriebsGmbH




Albert-Schweitzer-Gasse 3




1140 Vienna




Austria






Diclofenac sodium


Diclobene retard 100 mg - Kapseln


100 mg


Capsule, hard


Oral use




Austria







ratiopharm Arzneimittel VertriebsGmbH




Albert-Schweitzer-Gasse 3




1140 Vienna




Austria






Diclofenac sodium


Diclobene uno 150 mg - Retardtabletten


150 mg


Prolonged-release tablet


Oral use




Austria







1A Pharma GmbH




Stella-Klein-Löw-Weg 17




1020 Vienna




Austria






Diclofenac sodium


Diclofenac akut 1A Pharma 50 mg - lösbare Tabletten


50 mg


Soluble tablet


Oral use




Austria







Genericon Pharma Gesellschaft m.b.H.




Hafnerstraße 211




8054 Graz




Austria






Diclofenac sodium


Diclofenac Genericon 75 mg - Ampullen


75 mg/3 ml


Solution for injection/infusion


Intramuscular use, Intravenous use




Austria







Genericon Pharma Gesellschaft m.b.H.




Hafnerstraße 211




8054 Graz




Austria






Diclofenac sodium


Diclofenac "Genericon" 50 mg - Filmtabletten


50 mg


Film-coated tablet


Oral use




Austria







Genericon Pharma Gesellschaft m.b.H.




Hafnerstraße 211




8054 Graz




Austria






Diclofenac sodium


Diclofenac Genericon retard 100 mg Filmtabletten


100 mg


Film-coated tablet


Oral use




Austria







S.MED Handels GmbH




Zachgasse 1




1220 Vienna




Austria






Diclofenac sodium


DICLOFENAC "S.Med" 25 mg-Filmtabletten


25 mg


Film-coated tablet


Oral use




Austria







S.MED Handels GmbH




Zachgasse 1




1220 Vienna




Austria






Diclofenac sodium


DICLOFENAC "S.Med" 50 mg - Filmtabletten


50 mg


Film-coated tablet


Oral use




Austria







S.MED Handels GmbH




Zachgasse 1




1220 Vienna




Austria






Diclofenac sodium


Diclofenac ”S.Med“ 75 mg/3 ml - Ampullen


75 mg/3 ml


Solution for injection


Intramuscular use




Austria







S.MED Handels GmbH




Zachgasse 1




1220 Vienna




Austria






Diclofenac sodium


DICLOFENAC "S.Med" retard 100 mg - Tabletten


100 mg


Tablet


Oral use




Austria







S.MED Handels GmbH




Zachgasse 1




1220 Vienna




Austria






Diclofenac sodium


DICLOFENAC "S.Med" retard 75 mg - Tabletten


75 mg


Tablet


Oral use




Austria







G.L. Pharma GmbH




Schlossplatz 1




A-8502 Lannach




Austria






Diclofenac sodium


Diclofenac G.L. 50 mg - Filmtabletten


50 mg


Film-coated tablet


Oral use




Austria







1A Pharma GmbH




Stella-Klein-Löw-Weg 17




1020 Vienna




Austria






Diclofenac sodium


Diclofenac 1A Pharma retard 150 mg - Tabletten


150 mg


Prolonged-release tablet


Oral use




Austria







1A Pharma GmbH




Stella-Klein-Löw-Weg 17




1020 Vienna




Austria






Diclofenac sodium


Diclofenac 1A Pharma retard 75 mg - Tabletten


75 mg


Prolonged-release tablet


Oral use




Austria







G.L. Pharma GmbH




Schlossplatz 1




A-8502 Lannach




Austria






Diclofenac sodium


Diclofenac G.L. retard 100 mg - Filmtabletten


100 mg


Film-coated tablet


Oral use




Austria







Sandoz GmbH




Biochemiestraße 10




Kundl A-6250




Austria






Diclofenac sodium


Diclofenac Sandoz 75 mg – Ampullen


75 mg/3 ml


Solution for injection/infusion


Intramuscular use, Intravenous use




Austria







Sandoz GmbH




Biochemiestraße 10




Kundl A-6250




Austria






Diclofenac sodium


Diclofenac Sandoz 50 mg – Filmtabletten


50 mg


Film-coated tablet


Oral use




Austria







Sandoz GmbH




Biochemiestraße 10




Kundl A-6250




Austria






Diclofenac sodium


Diclofenac Sandoz 150 mg - Retardtabletten


150 mg


Prolonged-release tablet


Oral use




Austria







Sandoz GmbH




Biochemiestraße 10




Kundl A-6250




Austria






Diclofenac sodium


Diclofenac Sandoz 75 mg - Retardtabletten


75 mg


Prolonged-release tablet


Oral use




Austria







Sandoz GmbH




Biochemiestraße 10




Kundl A-6250




Austria






Diclofenac sodium


Diclofenac "Sandoz" retard 100 mg – Filmtabletten


100 mg


Film-coated tablet


Oral use




Austria







Lannacher Heilmittel Ges.m.b.H




Schlossplatz 1




8502 Lannach




Austria






Diclofenac sodium


Diclo-B „Lannacher“-Kapseln


50 mg


Capsule, hard


Oral use




Austria







Lannacher Heilmittel Ges.m.b.H




Schlossplatz 1




8502 Lannach




Austria






Diclofenac sodium


Diclo-B G.L.


50 mg


Capsule, hard


Oral use




Austria







STADA Arzneimittel GmbH




Muthgasse 36




1190 Vienna




Austria






Diclofenac sodium


Diclostad Ampullen


75 mg/3 ml


Solution for injection/infusion


Intramuscular use, Intravenous use




Austria







STADA Arzneimittel GmbH




Muthgasse 36




1190 Vienna




Austria






Diclofenac Sodium


Diclostad 50 mg Filmtabletten


50 mg


Film-coated tablet


Oral use




Austria







STADA Arzneimittel GmbH




Muthgasse 36




1190 Vienna




Austria






Diclofenac sodium


Diclostad retard 100 mg Filmtabletten


100 mg


Film-coated tablet


Oral use




Austria







G.L. Pharma GmbH




Schlossplatz 1




A-8502 Lannach




Austria






Diclofenac sodium


Diclovit-Kapseln


50 mg


Capsule, hard


Oral use




Austria







Fresenius Kabi Austria GmbH




Hafnerstrasse 36




Graz A-8055




Austria






Diclofenac sodium


Dolpasse 75 mg – Infusionslösung


75 mg/250 ml


Solution for Infusion


Intravenous use




Austria







Fresenius Kabi Austria GmbH




Hafnerstrasse 36




Graz A-8055




Austria






Diclofenac sodium


Dolpasse retard 100 mg - Filmtabletten


100 mg


Film-coated tablet


Oral use




Austria







Fresenius Kabi Austria GmbH




Hafnerstrasse 36




Graz A-8055




Austria






Diclofenac sodium
Orphenadrine citrate


Neodolpasse – Infusionslösung


75 mg/250 ml
30 mg/250 ml


Solution for Infusion


Intravenous use




Austria







MERCK GesmbH




Zimbagasse 5




1147 Vienna




Austria






Diclofenac sodium


Neurofenac - Kapseln


50 mg


Capsule, hard


Oral use




Austria







Gerot Pharmazeutika GmbH




Arnethgasse 3




A-1160 Vienna




Austria






Diclofenac sodium


Tratul retard 100 mg - Filmtabletten


100 mg


Film-coated tablet


Oral use




Austria







Novartis Pharma GmbH




Stella-Klein-Löw-Weg 17




1020 Vienna




Austria






Diclofenac sodium


Voltaren 25 mg - Filmtabletten


25 mg


Film-coated tablet


Oral use




Austria







Novartis Pharma GmbH




Stella-Klein-Löw-Weg 17




1020 Vienna




Austria






Diclofenac sodium


Voltaren 50 mg - Filmtabletten


50 mg


Film-coated tablet


Oral use




Austria







Novartis Pharma GmbH




Stella-Klein-Löw-Weg 17




1020 Vienna




Austria






Diclofenac sodium


Voltaren 75 mg/3 ml - Injektionslösung


75 mg/3 ml


Solution for injection/infusion


Intramuscular use, Intravenous use




Austria







Novartis Pharma GmbH




Stella-Klein-Löw-Weg 17




1020 Vienna




Austria






Diclofenac sodium


Voltaren 25 mg - Zäpfchen


25 mg


Suppository


Rectal use




Austria







Novartis Pharma GmbH




Stella-Klein-Löw-Weg 17




1020 Vienna




Austria






Diclofenac sodium


Voltaren 100 mg - Zäpfchen für Erwachsene


100 mg


Suppository


Rectal use




Austria







Novartis Pharma GmbH




Stella-Klein-Löw-Weg 17




1020 Vienna




Austria






Diclofenac sodium


Voltaren 50 mg - Zäpfchen für Erwachsene


50 mg


Suppository


Rectal use




Austria







Novartis Pharma GmbH




Stella-Klein-Löw-Weg 17




1020 Vienna




Austria






Diclofenac sodium


Voltaren retard 100 mg - Filmtabletten


100 mg


Film-coated tablet


Oral use




Austria







Gerot Pharmazeutika GmbH




Arnethgasse 3




A-1160 Vienna




Austria






Diclofenac Acid


Tratul 50 mg - Kapseln


50 mg


Gastro-resistant capsule, soft


Oral use




Austria







Novartis Pharma GmbH




Stella-Klein-Löw-Weg 17




1020 Vienna




Austria






Diclofenac Acid


Voltaren dispers - lösliche Tabletten


46,5 mg


Soluble tablet


Oral use




Austria







ratiopharm Arzneimittel VertriebsGmbH




Albert-Schweitzer-Gasse 3




1140 Vienna




Austria






Diclofenac potassium


Diclobene rapid 50 mg Filmtabletten


50 mg


Film-coated tablet


Oral use




Austria







Novartis Pharma GmbH




Stella-Klein-Löw-Weg 17




1020 Vienna




Austria






Diclofenac potassium


Voltaren 50 mg Pulver zur Herstellung einer Lösung zum Einnehmen


50 mg


Powder for oral solution


Oral use




Austria







Novartis Pharma GmbH




Stella-Klein-Löw-Weg 17




1020 Vienna




Austria






Diclofenac potassium


Voltaren rapid 50 mg - Dragees


50 mg


Coated tablet


Oral use




Belgium







Continental Pharma




Rijksweg, 12




B-2870 Puurs




Belgium






Diclofenac sodium
Misoprostol


ARTHROTEC 50


50 mg
0,2 mg


Modified-release tablet


Oral use




Belgium







Continental Pharma




Rijksweg, 12




B-2870 Puurs




Belgium






Diclofenac sodium
Misoprostol


ARTHROTEC 75


75 mg
0,2 mg


Modified-release tablet


Oral use




Belgium







NOVARTIS PHARMA N.V.




Medialaan, 40, box 1




1800 Vilvoorde




Belgium






Diclofenac potassium


CATAFLAM 50 MG


50 mg


Coated tablet


Oral use




Belgium







NOVARTIS PHARMA N.V.




Medialaan, 40, box 1




1800 Vilvoorde




Belgium






Diclofenac potassium


CATAFLAM 50 MG


50 mg


Powder for oral solution


Oral use




Belgium







NOVARTIS PHARMA N.V.




Medialaan, 40, box 1




1800 Vilvoorde




Belgium






Diclofenac


CATAFLAM DISPERSIBLE


46,5 mg


Dispersible tablet


Oral use




Belgium







APOTEX NV




Av. du Bourg. Etienne Demunter 5, box 8




1090 Jette




Belgium






Diclofenac sodium


DICLOFENAC APOTEX 100 MG


100 mg


Prolonged-release tablet


Oral use




Belgium







APOTEX NV




Av. du Bourg. Etienne Demunter 5, box 8




1090 Jette




Belgium






Diclofenac sodium


DICLOFENAC APOTEX 75 MG


75 mg


Prolonged-release tablet


Oral use




Belgium







N.V. Eurogenerics S.A




Esplanade Heysel b 22




B-1020 Bruxelles




Belgium






Diclofenac sodium


DICLOFENAC EG 100 MG


100 mg


Suppository


Rectal use




Belgium







N.V. Eurogenerics S.A




Esplanade Heysel b 22




B-1020 Bruxelles




Belgium






Diclofenac sodium


DICLOFENAC EG 25 MG


25 mg


Coated tablet


Oral use




Belgium







N.V. Eurogenerics S.A




Esplanade Heysel b 22




B-1020 Bruxelles




Belgium






Diclofenac sodium


DICLOFENAC EG 50 MG


50 mg


Coated tablet


Oral use




Belgium







N.V. Eurogenerics S.A




Esplanade Heysel b 22




B-1020 Bruxelles




Belgium






Diclofenac sodium


DICLOFENAC EG 75 MG


75 mg/3 ml


Solution for injection


Intramuscular use




Belgium







N.V. Eurogenerics S.A




Esplanade Heysel b 22




B-1020 Bruxelles




Belgium






Diclofenac sodium


DICLOFENAC EG RETARD 100 MG


100 mg


Prolonged-release tablet


Oral use




Belgium







N.V. Eurogenerics S.A




Esplanade Heysel b 22




B-1020 Bruxelles




Belgium






Diclofenac sodium


DICLOFENAC EG RETARD 75 MG


75 mg


Prolonged-release tablet


Oral use




Belgium







Mylan bvba




Rozendal Businesspark




Terhulpsesteenweg 6A




B-1560 Hoeilaart




Belgium






Diclofenac sodium


DICLOFENAC RETARD MYLAN 100 MG


100 mg


Prolonged-release tablet


Oral use




Belgium







Mylan bvba




Rozendal Businesspark




Terhulpsesteenweg 6A




B-1560 Hoeilaart




Belgium






Diclofenac sodium


DICLOFENAC RETARD MYLAN 75 MG


75 mg


Prolonged-release tablet


Oral use




Belgium







SANDOZ N.V.




Telecom Gardens




Medialaan 40




1800 Vilvoorde




Belgium






Diclofenac sodium


DICLOFENAC SANDOZ 50 MG


50 mg


Gastro-resistant tablet


Oral use




Belgium







SANDOZ N.V.




Telecom Gardens




Medialaan 40




1800 Vilvoorde




Belgium






Diclofenac sodium


DICLOFENAC SANDOZ 75 MG


75 mg/3 ml


Solution for injection


Intramuscular use, Intravenous use




Belgium







SANDOZ N.V.




Telecom Gardens




Medialaan 40




1800 Vilvoorde




Belgium






Diclofenac sodium


DICLOFENAC SANDOZ RETARD 100 MG


100 mg


Modified-release tablet


Oral use




Belgium







SANDOZ N.V.




Telecom Gardens




Medialaan 40




1800 Vilvoorde




Belgium






Diclofenac sodium


DICLOFENAC SANDOZ RETARD 75 MG


75 mg


Modified-release tablet


Oral use




Belgium







Teva Pharma Belgium N.V.




Laarstraat 16




2610 Wilrijk




Belgium






Diclofenac sodium


DICLOFENAC TEVA 100


100 mg


Suppository


Rectal use




Belgium







Teva Pharma Belgium N.V.




Laarstraat 16




2610 Wilrijk




Belgium






Diclofenac sodium


DICLOFENAC TEVA 100 MG RETARD


100 mg


Prolonged-release tablet


Oral use




Belgium







Teva Pharma Belgium N.V.




Laarstraat 16




2610 Wilrijk




Belgium






Diclofenac sodium


DICLOFENAC TEVA 50 MG


50 mg


Gastro-resistant tablet


Oral use




Belgium







Teva Pharma Belgium N.V.




Laarstraat 16




2610 Wilrijk




Belgium






Diclofenac sodium


DICLOFENAC TEVA 75 MG / 3 ML


75 mg/3 ml


Solution for injection


Intramuscular use




Belgium







Teva Pharma Belgium N.V.




Laarstraat 16




2610 Wilrijk




Belgium






Diclofenac sodium


DICLOFENAC TEVA 75 MG RETARD


75 mg


Prolonged-release tablet


Oral use




Belgium







Teva Pharma Belgium N.V.




Laarstraat 16




2610 Wilrijk




Belgium






Diclofenac potassium


DICLOFENAC-K-TEVA 50 MG COMPR


50 mg


Film-coated tablet


Oral use




Belgium







RATIOPHARM BELGIUM S.A.




Rue Saint-Lambert 141




1200 Woluwé-saint-lambert




Belgium






Diclofenac sodium


DICLOFENAC-RATIOPHARM 50 MG GASTRO-


50 mg


Gastro-resistant tablet


Oral use




Belgium







LABORATORIA QUALIPHAR N.V/S.A




Rijksweg 9




2880 Bornem




Belgium






Diclofenac sodium


DICLOFENACUM NATRI QUALIPHAR 50 MG


50 mg


Gastro-resistant tablet


Oral use




Belgium







SOCOBOM N.V.




Louizalaan 149 box 24




1050 Ixelles




Belgium






Diclofenac sodium


FLAMPHAR 50 MG


50 mg


Tablet


Oral use




Belgium







Daiichi Sankyo Belgium SA




Rue Fond Jean Pâques 5




B-1348 Louvain-la-Neuve




Belgium






Diclofenac sodium


MOTIFENE 75 MG


75 mg


Modified-release capsule


Oral use




Belgium







SOCOBOM N.V.




Louizalaan 149 box 24




1050 Ixelles




Belgium






Diclofenac sodium


POLYFLAM 75 MG


75 mg


Prolonged-release tablet


Oral use




Belgium







SOCOBOM N.V.




Louizalaan 149 box 24




1050 Ixelles




Belgium






Diclofenac sodium


POLYFLAM EX RUFIMAX EX ALGIRHUMA 50 MG


50 mg


Coated tablet


Oral use




Belgium







NOVARTIS PHARMA N.V.




Medialaan, 40, box 1




1800 Vilvoorde




Belgium






Diclofenac sodium


VOLTAREN 100


100 mg


Suppository


Rectal use




Belgium







NOVARTIS PHARMA N.V.




Medialaan, 40, box 1




1800 Vilvoorde




Belgium






Diclofenac sodium


VOLTAREN 25


25 mg


Gastro-resistant tablet


Oral use




Belgium







NOVARTIS PHARMA N.V.




Medialaan, 40, box 1




1800 Vilvoorde




Belgium






Diclofenac sodium


VOLTAREN 50


50 mg


Gastro-resistant tablet


Oral use




Belgium







NOVARTIS PHARMA N.V.




Medialaan, 40, box 1




1800 Vilvoorde




Belgium






Diclofenac sodium


VOLTAREN 75 MG/3 ML


75 mg/3 ml


Solution for injection


Intramuscular use




Belgium







NOVARTIS PHARMA N.V.




Medialaan, 40, box 1




1800 Vilvoorde




Belgium






Diclofenac sodium


VOLTAREN RETARD 100


100 mg


Tablet


Oral use




Belgium







NOVARTIS PHARMA N.V.




Medialaan, 40, box 1




1800 Vilvoorde




Belgium






Diclofenac sodium


VOLTAREN RETARD 75 MG


75 mg


Tablet


Oral use




Belgium







Novartis Consumer Health S.A.




Medialaan, 40




B-1800 Vilvoorde




Belgium






Diclofenac potassium


VOLTATABS 12,5 MG(EX:ZYMAMED)


12,5 mg


Coated tablet


Oral use




Bulgaria







Medochemie Ltd




1-10 Constantinoupoleos str




P.O. Box 51409




Limassol 3505




Cyprus






Diclofenac sodium


Almiral


50 mg


Gastro-resistant tablet


Oral use




Bulgaria







Medochemie Ltd




1-10 Constantinoupoleos str




P.O. Box 51409




Limassol 3505




Cyprus






Diclofenac sodium


Almiral


75 mg/3 ml


Solution for injection


Intramuscular use, Intravenous use




Bulgaria







PharmaSwiss Česká republika s.r.o.




Jankovcova 1569/2c




170 00 Praha 7 - Holešovice




Czech Republic






Diclofenac sodium


Diclofenac Duo


75 mg


Prolonged-release capsule, hard


Oral use




Bulgaria







Tchaikapharma Highquality Medicines




1 G. M. Dimitrov Blvd.




Sofia 1172




Bulgaria






Diclofenac sodium


Diclofenac-Tchaikapharma


50 mg


Gastro-resistant tablet


Oral use




Bulgaria







Hexal AG




Industriestraße 25




D-83607 Holzkirchen




Germany






Diclofenac sodium


Diclac


75 mg/3 ml


Solution for injection


Intramuscular use, Intravenous use




Bulgaria







Hexal AG




Industriestraße 25




D-83607 Holzkirchen




Germany






Diclofenac sodium


Diclac


75 mg


Modified-release tablet


Oral use




Bulgaria







Hexal AG




Industriestraße 25




D-83607 Holzkirchen




Germany






Diclofenac sodium


Diclac


150 mg


Modified-release tablet


Oral use




Bulgaria







Sopharma Pharmaceuticals




5 Lachezar Stanchev Str.




Sofia 1220




Bulgaria






Diclofenac sodium


Feloran


100 mg


Suppository


Rectal use




Bulgaria







Actavis EAD




29 Atanas Dukov Str.




Sofia 1407




Bulgaria






Diclofenac sodium


Feloran Actavis


100 mg


Prolonged-release tablet


Oral use




Bulgaria







Krka, d.d.




Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






Diclofenac sodium


Naklofen SR


100 mg


Prolonged-release tablet


Oral use




Bulgaria







Krka, d.d.




Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






Diclofenac sodium


Naklofen DUO


75 mg


Modified-release capsule, hard


Oral use




Bulgaria







Krka, d.d.




Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






Diclofenac sodium


Naklofen


75 mg/3 ml


Solution for injection


Intramuscular use




Bulgaria







Krka, d.d.




Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






Diclofenac sodium


Naklofen


50 mg


Gastro-resistant tablet


Oral use




Bulgaria







Fresenius Kabi Austria GmbH




Hafnerstrasse 36




Graz A-8055




Austria






Diclofenac sodium
Orphenadrine citrate


Neodolpasse


75 mg/250 ml
30 mg/250 ml


Solution for infusion


Intravenous use




Bulgaria







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenac sodium


Voltaren


25 mg


Gastro-resistant tablet


Oral use




Bulgaria







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenac sodium


Voltaren


100 mg


Suppository


Rectal use




Bulgaria







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenac sodium


Voltaren


50 mg


Suppository


Rectal use




Bulgaria







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenac potassium


Voltfast


50 mg


Powder for oral solution


Oral use




Bulgaria







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenac sodium


Voltaren


50 mg


Gastro-resistant tablet


Oral use




Bulgaria







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenac sodium


Voltaren Retard


100 mg


Prolonged-release tablet


Oral use




Bulgaria







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenac sodium


Voltaren


75 mg/3 ml


Solution for injection


Intramuscular use, Intravenous use




Bulgaria







Novartis Consumer Health GmbH




Zielstattstrasse 40




Munchen 81379




Germany






Diclofenac potassium


Voltaren Dolo


12,5 mg


Capsule, soft


Oral use




Bulgaria







Novartis Consumer Health GmbH




Zielstattstrasse 40




Munchen 81379




Germany






Diclofenac potassium


Voltaren Dolo


12,5 mg


Film-coated tablet


Oral use




Bulgaria







Sopharma Pharmaceuticals




5 Lachezar Stanchev Str.




Sofia 1220




Bulgaria






Diclofenac sodium


Feloran


25 mg/ml


solution for injection


Intramuscular use, Intravenous use




Cyprus







Medochemie Ltd




1-10 Constantinoupoleos str




P.O. Box 51409




Limassol 3505




Cyprus






Diclofenac sodium


ALMIRAL INJECTION 75 MG/3 ML


75 mg/3 ml


Injection


Intramuscular use




Cyprus







Medochemie Ltd




1-10 Constantinoupoleos str




P.O. Box 51409




Limassol 3505




Cyprus






Diclofenac sodium


ALMIRAL SUPPOSITORY 100 MG


100 mg


Suppository


Rectal use




Cyprus







Medochemie Ltd




1-10 Constantinoupoleos str




P.O. Box 51409




Limassol 3505




Cyprus






Diclofenac sodium


ALMIRAL SUPPOSITORY 50 MG


50 mg


Suppository


Rectal use




Cyprus







Medochemie Ltd




1-10 Constantinoupoleos str




P.O. Box 51409




Limassol 3505




Cyprus






Diclofenac sodium


ALMIRAL GASTRO-RESISTANT TABLET 25 MG


25 mg


Tablet


Oral use




Cyprus







Medochemie Ltd




1-10 Constantinoupoleos str




P.O. Box 51409




Limassol 3505




Cyprus






Diclofenac sodium


ALMIRAL GASTRO-RESISTANT TABLET 50 MG


50 mg


Tablet


Oral use




Cyprus







Medochemie Ltd




1-10 Constantinoupoleos str




P.O. Box 51409




Limassol 3505




Cyprus






Diclofenac sodium


ARESTON TABLET 50 MG


50 mg


Tablet


Oral use




Cyprus







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac potassium


CATAFLAM ORAL DROPS 1,5 %


15 mg/ml


Oral drops, solution


Oral use




Cyprus







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac potassium


CATAFLAM COATED TABLET 50 MG


50 mg


Tablet


Oral use




Cyprus







P.T.Hadjigeorgiou CO ltd,




P.O.Box 53158




3301 Lemesos




Cyprus






Diclofenac sodium


DICLAC INJECTION 75 MG/3 ML


75 mg/3 ml


Injection


Intramuscular use




Cyprus







Hexal AG




Industriestraße 25




D-83607 Holzkirchen




Germany






Diclofenac sodium


DICLAC 50 HEXAL GASTRO-RESISTANT TABLET 50 MG


50 mg


Tablet


Oral use




Cyprus







Hexal AG




Industriestraße 25




D-83607 Holzkirchen




Germany






Diclofenac sodium


DICLAC 75 ID HEXAL SUSTAINED RELEASE TABLET 75 MG


75 mg


Tablet


Oral use




Cyprus







Medlink Pharmaceuticals ltd




30 Armenias Str.




P.O.Box 26576




Strovolos




Cyprus






Diclofenac sodium


DIFENE DUAL CAPSULE 100 MG


100 mg


Capsule


Oral use




Cyprus







Medlink Pharmaceuticals ltd




30 Armenias Str.




P.O.Box 26576




Strovolos




Cyprus






Diclofenac sodium


DIFENE DUAL CAPSULE 75 MG


75 mg


Capsule


Oral use




Cyprus







Interpak ltd




Aharnon st




Industrial Estate




P.O. Box 51166




3502 Lemesos




Cyprus






Diclofenac sodium


NERITAN GASTRO RESISTANT TABLET 50 MG


50 mg


Tablet


Oral use




Cyprus







Interpak ltd




Aharnon st




Industrial Estate




P.O. Box 51166




3502 Lemesos




Cyprus






Diclofenac sodium


NERITAN GASTRO RESISTANT TABLET 25 MG


25 mg


Tablet


Oral use




Cyprus







Remedica ltd




Aharnon str.




P.O. Box 51706




Lemesos




Cyprus






Diclofenac sodium


REMETHAN SUPPOSITORY 100 MG


100 mg


Suppository


Rectal use




Cyprus







Remedica ltd




Aharnon str.




P.O. Box 51706




Lemesos




Cyprus






Diclofenac sodium


REMETHAN SUSTAINED RELEASE TABLET 100 MG


100 mg


Tablet


Oral use




Cyprus







Remedica ltd




Aharnon str.




P.O. Box 51706




Lemesos




Cyprus






Diclofenac sodium


REMETHAN GASTRO RESISTANT TABLET 25 MG


25 mg


Tablet


Oral use




Cyprus







Remedica ltd




Aharnon str.




P.O. Box 51706




Lemesos




Cyprus






Diclofenac sodium


REMETHAN GASTRO RESISTANT TABLET 50 MG


50 mg


Tablet


Oral use




Cyprus







Codal Synto ltd




33 Theklas Lysioti str.




P.O. Box 51785




Lemesos




Cyprus






Diclofenac sodium


TAKS INJECTION 75 MG/3 ML


75 mg/3 ml


Injection


Intramuscular use




Cyprus







Codal Synto ltd




33 Theklas Lysioti str.




P.O. Box 51785




Lemesos




Cyprus






Diclofenac sodium


TAKS GASTRO RESISTANT TABLET 50 MG


50 mg


Tablet


Oral use




Cyprus







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


VOLTAREN INJECTION 75 MG/3 ML


75 mg/3 ml


Injection


Intramuscular use




Cyprus







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


VOLTAREN SUPPOSITORY 100 MG


100 mg


Suppository


Rectal use




Cyprus







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


VOLTAREN SUPPOSITORY 50 MG


50 mg


Suppository


Rectal use




Cyprus







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


VOLTAREN GASTRO RESISTANT TABLET 50 MG


50 mg


Tablet


Oral use




Cyprus







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


VOLTAREN D DISPERSIBLE TABLET 50 MG


50 mg


Tablet


Oral use




Cyprus







Novartis Hellas S.A.C.I.




12th km




National Road No1




Metamorfosi Attiki




Athens




Greece






Diclofenac sodium


VOLTAREN DOLO FILM COATED TABLET 12,5 MG


12,5 mg


Tablet


Oral use




Cyprus







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


VOLTAREN FOR CHILDREN SUPPOSITORY 12,5 MG


12,5 mg


Suppository


Rectal use




Cyprus







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


VOLTAREN RETARD SUSTAINED RELEASE TABLET 100 MG


100 mg


Tablet


Oral use




Cyprus







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


VOLTAREN SR SUSTAINED RELEASE TABLET 75 MG


75 mg


Tablet


Oral use




Czech Republic







Medochemie Ltd




1-10 Constantinoupoleos str




P.O. Box 51409




Limassol 3505




Cyprus






Diclofenacum natricum


ALMIRAL


25 mg/ml


Solution for injection


Intramuscular use, Intravenous use




Czech Republic







Medochemie Ltd




1-10 Constantinoupoleos str




P.O. Box 51409




Limassol 3505




Cyprus






Diclofenacum natricum


ALMIRAL 50


50 mg


Gastro-resistant tablet


Oral use




Czech Republic







Apotex Europe B.V.




Darwinweg 20




2333 CR Leiden




The Netherlands






Diclofenacum natricum


APO-DICLO SR 100


100 mg


Modified-release tablet


Oral use




Czech Republic







Apotex Europe B.V.




Darwinweg 20




2333 CR Leiden




The Netherlands






Diclofenacum natricum


APO-DICLO 25 MG


25 mg


Gastro-resistant tablet


Oral use




Czech Republic







Apotex Europe B.V.




Darwinweg 20




2333 CR Leiden




The Netherlands






Diclofenacum natricum


APO-DICLO 50 MG


50 mg


Gastro-resistant tablet


Oral use




Czech Republic







ALIUD PHARMA GmbH & Co. KG




Gottlieb Daimler Strasse 19




D-89150 Laichingen




Germany






Diclofenacum natricum


DICLOFENAC AL RETARD


100 mg


Prolonged-release tablet


Oral use




Czech Republic







ALIUD PHARMA GmbH & Co. KG




Gottlieb Daimler Strasse 19




D-89150 Laichingen




Germany






Diclofenacum natricum


DICLOFENAC AL 25


25 mg


Film-coated tablet


Oral use




Czech Republic







ALIUD PHARMA GmbH & Co. KG




Gottlieb Daimler Strasse 19




D-89150 Laichingen




Germany






Diclofenacum natricum


DICLOFENAC AL 50


50 mg


Film-coated tablet


Oral use




Czech Republic







PharmaSwiss Česká republika s.r.o.




Jankovcova 1569/2c




170 00 Praha 7 - Holešovice




Czech Republic






Diclofenacum natricum


DICLOFENAC DUO PHARMASWISS 75 MG


75 mg


Modified-release capsule, hard


Oral use




Czech Republic







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenacum natricum


DICLOREUM


25 mg/ml


Solution for injection


Intramuscular use




Czech Republic







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenacum natricum


DICLOREUM RETARD


100 mg


Prolonged-release tablet


Oral use




Czech Republic







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenacum natricum


DICLOREUM 100


100 mg


Suppository


Rectal use




Czech Republic







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenacum natricum


DICLOREUM 50


50 mg


Suppository


Rectal use




Czech Republic







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenacum natricum


DICLOREUM 50


50 mg


Gastro-resistant tablet


Oral use




Czech Republic







Vitabalans OY




Varastokatu 8




FI-135 000 Hämeenlinna




Finland






Diclofenac potassium


DICUNO 25 MG POTAHOVANÉ TABLETY


25 mg


Film-coated tablet


Oral use




Czech Republic







Vitabalans OY




Varastokatu 8




FI-135 000 Hämeenlinna




Finland






Diclofenac potassium


DICUNO 50 MG POTAHOVANÉ TABLETY


50 mg


Film-coated tablet


Oral use




Czech Republic







Zentiva, k.s.




U kabelovny 130




102 37 Praha 10 - Dolní Měcholupy




Czech Republic






Diclofenacum natricum


DOLMINA INJ


25 mg/ml


Solution for injection


Intramuscular use, Intravenous use




Czech Republic







Zentiva, k.s.




U kabelovny 130




102 37 Praha 10 - Dolní Měcholupy




Czech Republic






Diclofenacum natricum


DOLMINA 100 SR


100 mg


Prolonged-release tablet


Oral use




Czech Republic







Zentiva, k.s.




U kabelovny 130




102 37 Praha 10 - Dolní Měcholupy




Czech Republic






Diclofenacum natricum


DOLMINA 50


50 mg


Film-coated tablet


Oral use




Czech Republic







IBSA Slovakia s.r.o.




Mytna 42




811 05 Bratislava




Slovak Republic






Diclofenacum epolaminum


FLECTOR EP RAPID 50 MG


50 mg


Granules for oral solution


Oral use




Czech Republic







Winthrop Arzneimittel GmbH




Industriestrasse 26




Mülheim-Kärlich




Germany






Diclofenacum natricum


MONOFLAM 100 MG


100 mg


Suppository


Rectal use




Czech Republic







Winthrop Arzneimittel GmbH




Industriestrasse 26




Mülheim-Kärlich




Germany






Diclofenacum natricum


MONOFLAM 50 MG


50 mg


Gastro-resistant tablet


Oral use




Czech Republic







Dr. R. Pfleger Chemische Fabrik GmbH




Dr.Robert Pfleger Strasse 12




D-96045 Bamberg




Germany






Diclofenacum natricum


MYOGIT 25


25 mg


Gastro-resistant tablet


Oral use




Czech Republic







Dr. R. Pfleger Chemische Fabrik GmbH




Dr.Robert Pfleger Strasse 12




D-96045 Bamberg




Germany






Diclofenacum natricum


MYOGIT 50


50 mg


Gastro-resistant tablet


Oral use




Czech Republic







Krka, d.d.




Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






Diclofenacum natricum


NAKLOFEN DUO TOBOLKY


75 mg


Modified-release capsule, hard


Oral use




Czech Republic







Fresenius Kabi Austria GmbH




Hafnerstrasse 36




Graz A-8055




Austria






Diclofenac sodium
Orphenadrine citrate


Neodolpasse


75 mg/250 ml
30 mg/250 ml


Solution for infusion


Intravenous use




Czech Republic







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenacum natricum


OLFEN-100 SR


100 mg


Prolonged-release capsule, hard


Oral use




Czech Republic







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenacum natricum


OLFEN-50


50 mg


Film-coated tablet


Oral use




Czech Republic







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenacum natricum


OLFEN-75


37,5 mg/ml


Solution for injection


Intramuscular use




Czech Republic







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenacum natricum


UNO


150 mg


Prolonged-release tablet


Oral use




Czech Republic







Herbacos Recordati s.r.o.




Štrossova 239




53003 Pardubice




Czech Republic






Diclofenacum natricum


VERAL 100 MG


100 mg


Suppository


Rectal use




Czech Republic







Herbacos Recordati s.r.o.




Štrossova 239




53003 Pardubice




Czech Republic






Diclofenacum natricum


VERAL 100 RETARD


100 mg


Modified-release tablet


Oral use




Czech Republic







Herbacos Recordati s.r.o.




Štrossova 239




53003 Pardubice




Czech Republic






Diclofenacum natricum


VERAL 25 MG


25 mg


Gastro-resistant tablet


Oral use




Czech Republic







Herbacos Recordati s.r.o.




Štrossova 239




53003 Pardubice




Czech Republic






Diclofenacum natricum


VERAL 50 MG


50 mg


Gastro-resistant tablet


Oral use




Czech Republic







Herbacos Recordati s.r.o.




Štrossova 239




53003 Pardubice




Czech Republic






Diclofenacum natricum


VERAL 75


25 mg/ml


Solution for injection


Intramuscular use, Intravenous use




Czech Republic







Herbacos Recordati s.r.o.




Štrossova 239




53003 Pardubice




Czech Republic






Diclofenacum natricum


VERAL 75 RETARD


75 mg


Modified-release tablet


Oral use




Czech Republic







Novartis s.r.o.




Na Pankráci 1724/129




140 00 Praha 4 - Nusle




Czech Republic






Diclofenacum natricum


VOLTAREN


25 mg/ml


Solution for injection


Intramuscular use, Intravenous use




Czech Republic







Novartis s.r.o.




Na Pankráci 1724/129




140 00 Praha 4 - Nusle




Czech Republic






Diclofenacum natricum


VOLTAREN RETARD


100 mg


Prolonged-release tablet


Oral use




Czech Republic







Novartis s.r.o.




Na Pankráci 1724/129




140 00 Praha 4 - Nusle




Czech Republic






Diclofenacum natricum


VOLTAREN 50


50 mg


Gastro-resistant tablet


Oral use




Czech Republic







Novartis s.r.o.




Na Pankráci 1724/129




140 00 Praha 4 - Nusle




Czech Republic






Diclofenac potassium


VOLTAREN RAPID 50 MG TABLETY


50 mg


Coated tablet


Oral use




Czech Republic







Novartis s.r.o.




Na Pankráci 1724/129




140 00 Praha 4 - Nusle




Czech Republic






Diclofenac potassium


VOLTAREN ACTIGO


12,5 mg


Film-coated tablet


Oral use




Czech Republic







Novartis s.r.o.




Na Pankráci 1724/129




140 00 Praha 4 - Nusle




Czech Republic






Diclofenac potassium


VOLTAREN ACTIGO EXTRA


25 mg


Coated tablet


Oral use




Czech Republic







Novartis s.r.o.




Na Pankráci 1724/129




140 00 Praha 4 - Nusle




Czech Republic






Diclofenac potassium


VOLTAREN RAPID 12,5 MG


12,5 mg


Capsule, soft


Oral use




Czech Republic







Novartis s.r.o.




Na Pankráci 1724/129




140 00 Praha 4 - Nusle




Czech Republic






Diclofenac potassium


VOLTAREN RAPID 25 MG


25 mg


Capsule, soft


Oral use




Denmark







PharmaCoDane ApS




Marielundvej 46 A




DK-2730 Herlev




Denmark






Diclofenac


Diclodan


50 mg


Suppository


Rectal use




Denmark







PharmaCoDane ApS




Marielundvej 46 A




DK-2730 Herlev




Denmark






Diclofenac


Diclodan


100 mg


Suppository


Rectal use




Denmark







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 Købenahvn S




Denmark






Diclofenac


Diclon


100 mg


Suppository


Rectal use




Denmark







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 Købenahvn S




Denmark






Diclofenac


Diclon Rapid


50 mg


Film-coated tablet


Oral use




Denmark







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 Købenahvn S




Denmark






Diclofenac


Diclon Rapid


25 mg


Film-coated tablet


Oral use




Denmark







Mylan AB




PO 230 33




Ynglingagatan 14




SE-104 35 Stockholm




Sweden






Diclofenac


Diklofenak "Mylan"


50 mg


Gastro-resistant tablet


Oral use




Denmark







Orifarm Generics A/S




PO 69, Energivej 15




DK-5260 Odense S




Denmark






Diclofenac


Diklofenak "Orifarm"


25 mg


Gastro-resistant tablet


Oral use




Denmark







Orifarm Generics A/S




PO 69, Energivej 15




DK-5260 Odense S




Denmark






Diclofenac


Diklofenak "Orifarm"


50 mg


Gastro-resistant tablet


Oral use




Denmark







Actavis Group PTC ehf




Reykjavikurvegi 76-78




IS-220 Hafnarfjördur




Iceæand






Diclofenac


Modifenac


75 mg


Modified-release capsule


Oral use




Denmark







Novartis Healthcare A/S




Lyngbyvej 172




DK-2100 København Ø




Denmark






Diclofenac


Voltaren


25 mg


Gastro-resistant tablet


Oral use




Denmark







Novartis Healthcare A/S




Lyngbyvej 172




DK-2100 København Ø




Denmark






Diclofenac


Voltaren


50 mg


Gastro-resistant tablet


Oral use




Denmark







Novartis Healthcare A/S




Lyngbyvej 172




DK-2100 København Ø




Denmark






Diclofenac


Voltaren


100 mg


Suppository


Rectal use




Denmark







Novartis Healthcare A/S




Lyngbyvej 172




DK-2100 København Ø




Denmark






Diclofenac


Voltaren


25 mg/ml


Solution for injection


Intramuscular use




Denmark







Novartis Healthcare A/S




Lyngbyvej 172




DK-2100 København Ø




Denmark






Diclofenac


Voltaren


50 mg


Suppository


Rectal use




Denmark







Novartis Healthcare A/S




Lyngbyvej 172




DK-2100 København Ø




Denmark






Diclofenac


Voltaren Dolo


12,5 mg


Film-coated tablet


Oral use




Denmark







Novartis Healthcare A/S




Lyngbyvej 172




DK-2100 København Ø




Denmark






Diclofenac


Voltaren Dolo


12,5 mg


Capsule, soft


Oral use




Denmark







Novartis Healthcare A/S




Lyngbyvej 172




DK-2100 København Ø




Denmark






Diclofenac


Voltaren Dolo


12,5 mg


Tablet


Oral use




Denmark







Novartis Healthcare A/S




Lyngbyvej 172




DK-2100 København Ø




Denmark






Diclofenac


Voltaren Rapid


50 mg


Tablet


Oral use




Denmark







Novartis Healthcare A/S




Lyngbyvej 172




DK-2100 København Ø




Denmark






Diclofenac


Voltaren Retard


100 mg


Prolonged-release tablet


Oral use




Denmark







Novartis Healthcare A/S




Lyngbyvej 172




DK-2100 København Ø




Denmark






Diclofenac


Voltaren Retard


75 mg


Prolonged-release tablet


Oral use




Denmark







BMM Pharma AB




Blasieholmsgatan 2




SE-111 48 Stockholm




Sweden






Diclofenac


Diclofenac "BMM Pharma"


50 mg


Gastro-resistant tablet


Oral use




Denmark







BMM Pharma AB




Blasieholmsgatan 2




SE-111 48 Stockholm




Sweden






Diclofenac


Diclofenac "BMM Pharma"


25 mg


Gastro-resistant tablet


Oral use




Denmark







Actavis Nordic A/S




Ørnegårdsvej 16




DK-2820 Gentofte




Denmark






Diclofenac


Diclofenac Rapid "Actavis"


50 mg


Film-coated tablet


Oral use




Denmark







Actavis Nordic A/S




Ørnegårdsvej 16




DK-2820 Gentofte




Denmark






Diclofenac


Diclofenac Rapid "Actavis"


25 mg


Film-coated tablet


Oral use




Denmark







Orifarm Generics A/S




PO 69, Energivej 15




DK-5260 Odense S




Denmark






Diclofenac


Diclofenac Rapid "Orifarm"


50 mg


Film-coated tablet


Oral use




Denmark







Orifarm Generics A/S




PO 69, Energivej 15




DK-5260 Odense S




Denmark






Diclofenac


Diclofenac Rapid "Orifarm"


25 mg


Film-coated tablet


Oral use




Denmark







Teva Denmark A/S




Parallelvej 10-12




DK-2800 Kongens Lyngby




Denmark






Diclofenac


Diclofenac Rapid "Teva"


50 mg


Film-coated tablet


Oral use




Denmark







Sandoz GmbH




Biochemiestraße 10




Kundl A-6250




Austria






Diclofenac


Diclon


50 mg


Gastro-resistant tablet


Oral use




Denmark







Sandoz GmbH




Biochemiestraße 10




Kundl A-6250




Austria






Diclofenac


Diclon


100 mg


Prolonged-release tablet


Oral use




Denmark







Sandoz GmbH




Biochemiestraße 10




Kundl A-6250




Austria






Diclofenac


Diclon


75 mg


Prolonged-release tablet


Oral use




Denmark







Sandoz GmbH




Biochemiestraße 10




Kundl A-6250




Austria






Diclofenac


Diclon


25 mg


Gastro-resistant tablet


Oral use




Denmark







Actavis Group PTC ehf




Reykjavikurvegi 76-78




IS-220 Hafnarfjördur




Iceæand






Diclofenac


Diclopax


25 mg


Film-coated tablet


Oral use




Denmark







Actavis Group PTC ehf




Reykjavikurvegi 76-78




IS-220 Hafnarfjördur




Iceæand






Diclofenac


Diclopax


50 mg


Film-coated tablet


Oral use




Denmark







Mimer Medical




Svärdvägen 3B




SE-182 33 Danderyd




Sweden






Diclofenac


Diklotab


25 mg


Film-coated tablet


Oral use




Denmark







Mimer Medical




Svärdvägen 3B




SE-182 33 Danderyd




Sweden






Diclofenac


Diklotab


50 mg


Film-coated tablet


Oral use




Denmark







Meda OTC AB




Östermalmsgatan 19




11426 Stockholm




Sweden






Diclofenac


Eeze


25 mg


Film-coated tablet


Oral use




Denmark







Actavis Group PTC ehf




Reykjavikurvegi 76-78




IS-220 Hafnarfjördur




Iceæand






Diclofenac


Fenacta


12,5 mg


Film-coated tablet


Oral use




Denmark







Vitabalans OY




Varastokatu 8




FI-135 000 Hämeenlinna




Finland






Diclofenac


Dicuno


50 mg


Film-coated tablet


Oral use




Denmark







Vitabalans OY




Varastokatu 8




FI-135 000 Hämeenlinna




Finland






Diclofenac


Dicuno


25 mg


Film-coated tablet


Oral use




Denmark







Pfizer ApS




Lautrupvang 8




DK-2750 Ballerup




Denmark






Diclofenac
Misoprostol


Arthrotec


50 mg
0,2 mg


Tablet


Oral use




Denmark







Pfizer ApS




Lautrupvang 8




DK-2750 Ballerup




Denmark






Diclofenac
Misoprostol


Arthrotec Forte


75 mg
0,2 mg


Tablet


Oral use




Estonia







Berlin-Chemie AG




(Menarini Group)




Glienicker Weg 125




12489 Berlin




Germany






Diclofenac


DICLOBERL 75 MG/3 ML


25 mg/ml


Solution for injection


Intramuscular use




Estonia







Berlin-Chemie AG




(Menarini Group)




Glienicker Weg 125




12489 Berlin




Germany






Diclofenac


DICLOBERL RETARD


100 mg


Prolonged-release capsule, hard


Oral use




Estonia







G.L. Pharma GmbH




Schlossplatz 1




A-8502 Lannach




Austria






Diclofenac


DICLOMELAN 50 MG


50 mg


Gastro-resistant tablet


Oral use




Estonia







G.L. Pharma GmbH




Schlossplatz 1




A-8502 Lannach




Austria






Diclofenac


DICLOMELAN


100 mg


Suppository


Rectal use




Estonia







G.L. Pharma GmbH




Schlossplatz 1




A-8502 Lannach




Austria






Diclofenac


DICLOMELAN RETARD 100 MG


100 mg


Prolonged-release tablet


Oral use




Estonia







Krka, d.d.




Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






Diclofenac


NAKLOFEN


50 mg


Gastro-resistant tablet


Oral use




Estonia







Krka, d.d.




Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






Diclofenac


NAKLOFEN


50 mg


Suppository


Rectal use




Estonia







Krka, d.d.




Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






Diclofenac


NAKLOFEN


25 mg/ml


Solution for injection


Intramuscular use




Estonia







Krka, d.d.




Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






Diclofenac


NAKLOFEN SR


100 mg


Prolonged-release tablet


Oral use




Estonia







Medochemie Ltd




1-10 Constantinoupoleos str




P.O. Box 51409




Limassol 3505




Cyprus






Diclofenac


ALMIRAL


25 mg/ml


Solution for injection


Intramuscular use, Intravenous use




Estonia







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenac


OLFEN DEPOCAPS


100 mg


Prolonged-release capsule, hard


Oral use




Estonia







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenac


OLFEN DEPOCAPS


75 mg


Prolonged-release tablet


Oral use




Estonia







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Diclofenac


CATAFLAM


50 mg


Coated tablet


Oral use




Estonia







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Diclofenac


VOLTAREN


25 mg/ml


Solution for injection


Intramuscular use




Estonia







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Diclofenac


VOLTAREN RETARD


100 mg


Prolonged-release tablet


Oral use




Estonia







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Diclofenac


VOLTAREN AKTI


12,5 mg


Film-coated tablet


Oral use




Estonia







Pfizer Enterprises SARL




Round-Point du Kirchberg




51, Avenue J.F.Kennedy




L-1855 Luxembourg




Luxembourg






Diclofenac
Misoprostol


ARTHROTEC


50 mg
0,2 mg


Modified-release tablet


Oral use




Estonia







Pharmaswiss Eesti OÜ




Tammsaare tee 47




11316 Tallinn




Estonia






Diclofenac


DICLORAPID


75 mg


Gastro-resistant capsule, hard


Oral use




Estonia







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac


DICLOFENAC- RATIOPHARM 50 MG


50 mg


Gastro-resistant tablet


Oral use




Estonia







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac


DICLOFENAC-RATIOPHARM 50 MG


50 mg


Suppository


Rectal use




Estonia







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac


DICLOFENAC-RATIOPHARM 100 MG


100 mg


Suppository


Rectal use




Estonia







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac


DICLOFENAC-RATIOPHARM 75 MG/2 ML


75 mg/2 ml


Solution for injection


Intramuscular use




Estonia







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac


DICLOFENAC-RATIOPHARM UNO


150 mg


Modified-release tablet


Oral use




Estonia







Sandoz d.d.




Verovskova 57




SI-1000 Ljubljana




Slovenia






Diclofenac


DICLAC 100


100 mg


Suppository


Rectal use




Estonia







Sandoz d.d.




Verovskova 57




SI-1000 Ljubljana




Slovenia






Diclofenac


DICLAC


25 mg/ml


Solution for injection


Intramuscular use




Estonia







Sandoz d.d.




Verovskova 57




SI-1000 Ljubljana




Slovenia






Diclofenac


DICLAC ID 75 MG


75 mg


Modified-release tablet


Oral use




Estonia







Sandoz d.d.




Verovskova 57




SI-1000 Ljubljana




Slovenia






Diclofenac


DICLAC ID 150 MG


150 mg


Modified-release tablet


Oral use




Estonia







Sandoz d.d.




Verovskova 57




SI-1000 Ljubljana




Slovenia






Diclofenac


DICLAC 100 MG


100 mg


Prolonged-release tablet


Oral use




Estonia







Vitabalans OY




Varastokatu 8




FI-135 000 Hämeenlinna




Finland






Diclofenac


DICUNO


25 mg


Film-coated tablet


Oral use




Estonia







Vitabalans OY




Varastokatu 8




FI-135 000 Hämeenlinna




Finland






Diclofenac


DICUNO


50 mg


Film-coated tablet


Oral use




Finland







Orifarm Generics A/S




PO 69, Energivej 15




DK-5260 Odense S




Denmark






Diclofenacum kalium


Diclofenac Rapid Orifarm


50 mg


Film-coated tablet


oral use




Finland







ratiopharm Oy




P.O.Box 67




02631 Espoo




Finland






Diclofenacum kalium


Diclomex Rapid


50 mg


Film-coated tablet


oral use




Finland







Vitabalans OY




Varastokatu 8




FI-135 000 Hämeenlinna




Finland






Diclofenacum kalium


Dicuno


25 mg


Film-coated tablet


oral use




Finland







Vitabalans OY




Varastokatu 8




FI-135 000 Hämeenlinna




Finland






Diclofenacum kalium


Dicuno


50 mg


Film-coated tablet


oral use




Finland







Meda OTC AB




Östermalmsgatan 19




11426 Stockholm




Sweden






Diclofenacum kalium


Eeze


25 mg


Film-coated tablet


oral use




Finland







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Diclofenacum kalium


Voltaren Rapid


25 mg


Coated tablet


oral use




Finland







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Diclofenacum kalium


Voltaren Rapid


50 mg


Coated tablet


oral use




Finland







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Diclofenacum kalium


Voltfast


50 mg


Powder for oral solution


oral use




Finland







Pfizer Oy




Tietokuja 4




00330 Helsinki




Finland






Diclofenacum natricum
Misoprostolum


Arthrotec


50 mg
0,2 mg


Tablet


oral use




Finland







Pfizer Oy




Tietokuja 4




00330 Helsinki




Finland






Diclofenacum natricum
Misoprostolum


Arthrotec Forte


75 mg
0,2 mg


Prolonged-release tablet


oral use




Finland







BMM Pharma AB




Blasieholmsgatan 2




SE-111 48 Stockholm




Sweden






Diclofenacum natricum


Diclofenac BMM Pharma


25 mg


Gastro-resistant tablet


oral use




Finland







BMM Pharma AB




Blasieholmsgatan 2




SE-111 48 Stockholm




Sweden






Diclofenacum natricum


Diclofenac BMM Pharma


50 mg


Gastro-resistant tablet


oral use




Finland







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenacum natricum


Diclomex


25 mg


Gastro-resistant tablet


oral use




Finland







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenacum natricum


Diclomex


50 mg


Gastro-resistant tablet


oral use




Finland







Oy Stada Pharma Ab




P.O.Box 1310




00101 Helsinki




Finland






Diclofenacum natricum


Motifene Dual


75 mg


Prolonged-release capsule


oral use




Finland







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Diclofenacum natricum


Voltaren


100 mg


Suppository


rectal use




Finland







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Diclofenacum natricum


Voltaren


25 mg


Gastro-resistant tablet


oral use




Finland







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Diclofenacum natricum


Voltaren


25 mg/ml


Solution for injection /concentrate for solution for infusion


Intramuscular use, Intravenous use




Finland







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Diclofenacum natricum


Voltaren


50 mg


Gastro-resistant tablet


oral use




Finland







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Diclofenacum natricum


Voltaren Retard


100 mg


Prolonged-release tablet


oral use




Finland







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Diclofenacum natricum


Voltaren Retard


75 mg


Prolonged-release tablet


oral use




France







Laboratoires Genevrier




280, rue de Goa




Les Trois Moulins - Parc de Sophia Antipolis




06600 Antibes




France






Diclofenac epolamine


FLECTOR 25 mg, granulés pour solution buvable en sachet-dose


25 mg


Granules for oral solution


Oral use




France







Laboratoires Genevrier




280, rue de Goa




Les Trois Moulins - Parc de Sophia Antipolis




06600 Antibes




France






Diclofenac epolamine


FLECTOR 50 mg, granulés pour solution buvable en sachet-dose


50 mg


Granules for oral solution


Oral use




France







Actavis Group PTC ehf




Reykjavikurvegi 76-78




IS-220 Hafnarfjördur




Iceæand






Diclofenac potassium


DICLOFENAC ACTAVIS 12,5 mg, comprimé pelliculé


12,5 mg


Film-coated tablet


Oral use




France







NOVARTIS SANTE FAMILIALE




14, boulevard Richelieu




92500 Rueil-Malmaison




France






Diclofenac potassium


VOLTARENDOLO 12,5 mg, comprimé enrobé


12,5 mg


Coated tablet


Oral use




France







ARROW GENERIQUES




26, avenue Tony Garnier




69007 Lyon




France






Diclofenac sodium


DICLOFENAC ARROW 50 mg, comprimé gastro-résistant


50 mg


Gastro-resistant tablet


Oral use




France







BIOGARAN




15, boulevard Charles de Gaulle




92700 Colombes




France






Diclofenac sodium


DICLOFENAC BIOGARAN 50 mg, comprimé pelliculé gastrorésistant


50 mg


Film-coated gastro-resistant tablet


Oral use




France







SANDOZ




49, avenue Georges Pompidou




92300 Levallois-Perret




France






Diclofenac sodium


DICLOFENAC BIOSTABILEX 50 mg, comprimé gastro-résistant


50 mg


Gastro-resistant tablet


Oral use




France







CRISTERS




22 quai Gallieni




92150 Suresnes




France






Diclofenac sodium


DICLOFENAC CRISTERS 50 mg, comprimé gastro-résistant


50 mg


Gastro-resistant tablet


Oral use




France







EG LABO - LABORATOIRES EUROGENERICS




"Le Quintet" - bâtiment A




12, rue Danjou




92517 Boulogne Billancourt Cedex




France






Diclofenac sodium


DICLOFENAC EG 50 mg, comprimé gastro-résistant


50 mg


Gastro-resistant tablet


Oral use




France







MYLAN SAS




117, allée des Parcs




69800 Saint-Priest




France






Diclofenac sodium


DICLOFENAC MYLAN 25 mg, comprimé gastro-résistant


25 mg


Gastro-resistant tablet


Oral use




France







MYLAN SAS




117, allée des Parcs




69800 Saint-Priest




France






Diclofenac sodium


DICLOFENAC MYLAN 50 mg, comprimé gastro-résistant


50 mg


Gastro-resistant tablet


Oral use




France







SANDOZ




49, avenue Georges Pompidou




92300 Levallois-Perret




France






Diclofenac sodium


DICLOFENAC SANDOZ 50 mg, comprimé enrobé gastro-résistant


50 mg


Gastro-resistant coated tablet


Oral use




France







TEVA SANTE




110, Esplanade du Général de Gaulle




92931 Paris La Défense Cedex




France






Diclofenac sodium


DICLOFENAC TEVA 25 mg, comprimé enrobé gastro-résistant


25 mg


Gastro-resistant coated tablet


Oral use




France







TEVA SANTE




110, Esplanade du Général de Gaulle




92931 Paris La Défense Cedex




France






Diclofenac sodium


DICLOFENAC TEVA 50 mg, comprimé enrobé gastro-résistant


50 mg


Gastro-resistant coated tablet


Oral use




France







NOVARTIS PHARMA




2-4, rue Lionel Terray




92500 Rueil-Malmaison




France






Diclofenac sodium


VOLTARENE 100 mg, suppositoire


100 mg


Suppository


Rectal use




France







NOVARTIS PHARMA




2-4, rue Lionel Terray




92500 Rueil-Malmaison




France






Diclofenac sodium


VOLTARENE 25 mg, comprimé gastro-résistant


25 mg


Gastro-resistant tablet


Oral use




France







NOVARTIS PHARMA




2-4, rue Lionel Terray




92500 Rueil-Malmaison




France






Diclofenac sodium


VOLTARENE 50 mg, comprimé enrobé gastro-résistant


50 mg


Gastro-resistant coated tablet


Oral use




France







NOVARTIS PHARMA




2-4, rue Lionel Terray




92500 Rueil-Malmaison




France






Diclofenac sodium


VOLTARENE 75 mg/3 ml, solution injectable


75 mg/3 ml


Solution for injection


Intramuscular use




France







NOVARTIS PHARMA




2-4, rue Lionel Terray




92500 Rueil-Malmaison




France






Diclofenac sodium


VOLTARENE ENFANT, suppositoire


25 mg


Suppository


Rectal use




France







NOVARTIS PHARMA




2-4, rue Lionel Terray




92500 Rueil-Malmaison




France






Diclofenac sodium


VOLTARENE LP 100 mg, comprimé enrobé à libération prolongée


100 mg


Prolonged-release coated tablet


Oral use




France







NOVARTIS PHARMA




2-4, rue Lionel Terray




92500 Rueil-Malmaison




France






Diclofenac sodium


VOLTARENE LP 75 mg, comprimé enrobé à libération prolongée


75 mg


Prolonged-release coated tablet


Oral use




France







Pfizer Holding France




23-25, avenue du Docteur Lannelongue




75014 Paris




France






Diclofenac sodium
Misoprostol


ARTOTEC 50 mg/0,2 mg, comprimé gastro-résistant


50 mg
0,2 mg


Gastro-resistant tablet


Oral use




France







Pfizer Holding France




23-25, avenue du Docteur Lannelongue




75014 Paris




France






Diclofenac sodium
Misoprostol


ARTOTEC 75 mg/0,2 mg, comprimé gastro-résistant


75 mg
0,2 mg


Gastro-resistant tablet


Oral use




France







TEVA GmbH




Graf-Arco-Str. 3




89079 Ulm




Germany






Diclofenac sodium


Xelaran Brausetablette 25 mg


25 mg


Effervescent tablet


oral use




Germany







1 A Pharma




Keltenring 1+3




82041 Oberhaching




Germany






Diclofenac sodium


Diclo 100 retard - 1 A Pharma


100 mg


Prolonged-release tablet


Oral use




Germany







1 A Pharma




Keltenring 1+3




82041 Oberhaching




Germany






Diclofenac sodium


Diclo 25 - 1 A Pharma


25 mg


Gastro-resistant tablet


Oral use




Germany







1 A Pharma




Keltenring 1+3




82041 Oberhaching




Germany






Diclofenac sodium


Diclo 50 - 1 A Pharma


50 mg


Gastro-resistant tablet


Oral use




Germany







1 A Pharma




Keltenring 1+3




82041 Oberhaching




Germany






Diclofenac sodium


Diclo 75 SL - 1 A Pharma


75 mg


Prolonged-release tablet


Oral use




Germany







1 A Pharma




Keltenring 1+3




82041 Oberhaching




Germany






Diclofenac sodium


Diclofenac- 1 A Pharma 100 mg Zäpfchen


100 mg


Suppository


Rectal use




Germany







1 A Pharma




Keltenring 1+3




82041 Oberhaching




Germany






Diclofenac sodium


Diclofenac- 1 A Pharma 50 mg Zäpfchen


50 mg


Suppository


Rectal use




Germany







AbZ-Pharma GmbH




Graf-Arco-Strasse 3




89079 Ulm




Germany






Diclofenac sodium


Diclofenac AbZ 25 mg Tabletten


25 mg


Gastro-resistant tablet


Oral use




Germany







AbZ-Pharma GmbH




Graf-Arco-Strasse 3




89079 Ulm




Germany






Diclofenac sodium


Diclofenac AbZ 50 mg Tabletten


50 mg


Gastro-resistant tablet


Oral use




Germany







AbZ-Pharma GmbH




Graf-Arco-Strasse 3




89079 Ulm




Germany






Diclofenac sodium


Diclofenac AbZ 50 mg Trinktabletten


50 mg


Dispersible tablet


Oral use




Germany







Actavis Deutschland GmbH & Co. KG




Willy-Brandt-Allee 2




81829 München




Germany






Diclofenac sodium


Diclo Divido


75 mg


Prolonged-release capsule, hard


Oral use




Germany







Actavis Deutschland GmbH & Co. KG




Willy-Brandt-Allee 2




81829 München




Germany






Diclofenac sodium


Diclo-Divido long


75 mg


Prolonged-release capsule, hard


Oral use




Germany







Actavis Deutschland GmbH & Co. KG




Willy-Brandt-Allee 2




81829 München




Germany






Diclofenac sodium


Diclofenac-Actavis 100 mg


100 mg


Prolonged-release capsule


Oral use




Germany







Actavis Deutschland GmbH & Co. KG




Willy-Brandt-Allee 2




81829 München




Germany






Diclofenac sodium


Diclofenac-Actavis 50 mg


50 mg


Gastro-resistant capsule


Oral use




Germany







ALIUD PHARMA GmbH & Co. KG




Gottlieb Daimler Strasse 19




D-89150 Laichingen




Germany






Diclofenac kalium


Diclo AL akut 12,5 mg


12,5 mg


Film-coated tablet


Oral use




Germany







ALIUD PHARMA GmbH & Co. KG




Gottlieb Daimler Strasse 19




D-89150 Laichingen




Germany






Diclofenac sodium


Diclofenac AL 100


100 mg


Suppository


Rectal use




Germany







ALIUD PHARMA GmbH & Co. KG




Gottlieb Daimler Strasse 19




D-89150 Laichingen




Germany






Diclofenac sodium


Diclofenac AL 25


25 mg


Gastro-resistant tablet


Oral use




Germany







ALIUD PHARMA GmbH & Co. KG




Gottlieb Daimler Strasse 19




D-89150 Laichingen




Germany






Diclofenac sodium


Diclofenac AL 50


50 mg


Gastro-resistant tablet


Oral use




Germany







ALIUD PHARMA GmbH & Co. KG




Gottlieb Daimler Strasse 19




D-89150 Laichingen




Germany






Diclofenac sodium


Diclofenac AL 50 Supp.


50 mg


Suppository


Rectal use




Germany







ALIUD PHARMA GmbH & Co. KG




Gottlieb Daimler Strasse 19




D-89150 Laichingen




Germany






Diclofenac sodium


Diclofenac AL i.m.


75 mg


Solution for injection


Intramuscular use




Germany







ALIUD PHARMA GmbH & Co. KG




Gottlieb Daimler Strasse 19




D-89150 Laichingen




Germany






Diclofenac sodium


Diclofenac AL retard


100 mg


Prolonged-release tablet


Oral use




Germany







ALIUD PHARMA GmbH & Co. KG




Gottlieb Daimler Strasse 19




D-89150 Laichingen




Germany






Diclofenac kalium


Diclofenac-Kalium AL 25 mg Filmtabletten


25 mg


Film-coated tablet


Oral use




Germany







AWD.pharma GmbH & Co. KG




Wasastr. 50




01445 Radebeul




Germany






Diclofenac sodium


Rewodina 25 mg


25 mg


Gastro-resistant tablet


Oral use




Germany







AWD.pharma GmbH & Co. KG




Wasastr. 50




01445 Radebeul




Germany






Diclofenac sodium


Rewodina 50 mg


50 mg


Gastro-resistant tablet


Oral use




Germany







AWD.pharma GmbH & Co. KG




Wasastr. 50




01445 Radebeul




Germany






Diclofenac sodium


Rewodina dual 75 Kaps


75 mg


Capsule


Oral use




Germany







AWD.pharma GmbH & Co. KG




Wasastr. 50




01445 Radebeul




Germany






Diclofenac sodium


Rewodina uno 100


100 mg


Capsule


Oral use




Germany







AWD.pharma GmbH & Co. KG




Wasastr. 50




01445 Radebeul




Germany






Diclofenac sodium


Xelaran Brausetablette 50 mg


50 mg


Effervescent tablet


Oral use




Germany







Berlin-Chemie AG




(Menarini Group)




Glienicker Weg 125




12489 Berlin




Germany






Diclofenac sodium


Dicloberl 100 mg Zäpfchen


100 mg


Suppository


Rectal use




Germany







Berlin-Chemie AG




(Menarini Group)




Glienicker Weg 125




12489 Berlin




Germany






Diclofenac sodium


Dicloberl 50 mg
Tabletten


50 mg


Gastro-resistent tablet


Oral use




Germany







Berlin-Chemie AG




(Menarini Group)




Glienicker Weg 125




12489 Berlin




Germany






Diclofenac sodium


Dicloberl N 75


75 mg


Solution for injection


Intramuscular use




Germany







betapharm Arzneimittel GmbH




Kobelweg 95




86156 Augsburg




Germany






Diclofenac sodium


Diclo dispers


50 mg


Dispersible tablet


Oral use




Germany







betapharm Arzneimittel GmbH




Kobelweg 95




86156 Augsburg




Germany






Diclofenac sodium


Diclofenbeta 100


100 mg


Suppository


Rectal use




Germany







betapharm Arzneimittel GmbH




Kobelweg 95




86156 Augsburg




Germany






Diclofenac sodium


Diclofenbeta 100 retard


100 mg


Prolonged-release tablet


Oral use




Germany







betapharm Arzneimittel GmbH




Kobelweg 95




86156 Augsburg




Germany






Diclofenac sodium


Diclofenbeta 25


25 mg


Gastro-resistant tablet


Oral use




Germany







betapharm Arzneimittel GmbH




Kobelweg 95




86156 Augsburg




Germany






Diclofenac sodium


Diclofenbeta 50


50 mg


Gastro-resistant tablet


Oral use




Germany







Chephasaar Chemisch-Pharmazeutische Fabrik GmbH




Muehlstr. 50




66386 Sankt Ingbert




Germany






Diclofenac sodium


Diclo-saar 100 mg Retardtablette


100 mg


Prolonged-release tablet


Oral use




Germany







Chephasaar Chemisch-Pharmazeutische Fabrik GmbH




Muehlstr. 50




66386 Sankt Ingbert




Germany






Diclofenac sodium


Diclo-saar 50 mg magensaftresistente Tabletten


50 mg


Gastro-resistant tablet


Oral use




Germany







Chephasaar Chemisch-Pharmazeutische Fabrik GmbH




Muehlstr. 50




66386 Sankt Ingbert




Germany






Diclofenac sodium


Diclo-saar 75 mg SF Injektionslösung


75 mg


Solution for injection


Intramuscular use




Germany







CT Arzneimittel GmbH




Graf-Arco-Strasse 3




89079 Ulm




Germany






Diclofenac sodium


Diclo-CT 100 mg Supp.


100 mg


Suppository


Rectal use




Germany







CT Arzneimittel GmbH




Graf-Arco-Strasse 3




89079 Ulm




Germany






Diclofenac sodium


Diclo-CT 25 mg Tabletten


25 mg


Gastro-resistant tablet


Oral use




Germany







CT Arzneimittel GmbH




Graf-Arco-Strasse 3




89079 Ulm




Germany






Diclofenac sodium


Diclo-CT 50 mg Trinktabletten


50 mg


Dispersible tablet


Oral use




Germany







CT Arzneimittel GmbH




Graf-Arco-Strasse 3




89079 Ulm




Germany






Diclofenac sodium


Diclo-CT 50 mg Supp.


50 mg


Suppository


Rectal use




Germany







CT Arzneimittel GmbH




Graf-Arco-Strasse 3




89079 Ulm




Germany






Diclofenac sodium


Diclo-CT 50 mg Tabletten


50 mg


Gastro-resistant tablet


Oral use




Germany







CT Arzneimittel GmbH




Graf-Arco-Strasse 3




89079 Ulm




Germany






Diclofenac sodium


Diclo-CT 75 mg/2 ml Ampullen


75 mg


Solution for injection


Intramuscular use




Germany







CT Arzneimittel GmbH




Graf-Arco-Strasse 3




89079 Ulm




Germany






Diclofenac kalium


Diclo-CT akut 12,5 mg Filmtabletten


12,5 mg


Film-coated tablet


Oral use




Germany







Denk Pharma GmbH & Co. KG




Prinzregentenstr. 79




81675 München




Germany






Diclofenac sodium


Diclo-Denk 100 mg Zäpfchen


100 mg


Suppository


Rectal use




Germany







Denk Pharma GmbH & Co. KG




Prinzregentenstr. 79




81675 München




Germany






Diclofenac sodium


DICLO-DENK 100 mg RETARD


100 mg


Prolonged-release tablet


Oral use




Germany







Dexcel Pharma GmbH




Carl-Zeiss-Str. 2




63755 Alzenau




Germany






Diclofenac sodium


Diclofenac Atid 50 mg


50 mg


Gastro-resistant tablet


Oral use




Germany







Dexcel Pharma GmbH




Carl-Zeiss-Str. 2




63755 Alzenau




Germany






Diclofenac sodium


Diclofenac Atid retard


100 mg


Prolonged-release tablet


Oral use




Germany







DOCPHARM Arzneimittelvertrieb GmbH & Co.




Kommanditgesellschaft auf Aktien




Greschbachstr. 7




76229 Karlsruhe




Germany






Diclofenac sodium


Diclafenac PB retard 100 mg


100 mg


Prolonged-release tablet


Oral use




Germany







Dolorgiet GmbH & Co. KG




Otto-von-Guericke-Str. 1




53757 Sankt Augustin




Germany






Diclofenac sodium


Dolgit-Diclo 100


100 mg


Prolonged-release tablet


Oral use




Germany







Dolorgiet GmbH & Co. KG




Otto-von-Guericke-Str. 1




53757 Sankt Augustin




Germany






Diclofenac sodium


Dolgit-Diclo 50


50 mg


Gastro-resistant tablet


Oral use




Germany







Dr. R. Pfleger Chemische Fabrik GmbH




Dr.Robert Pfleger Strasse 12




D-96045 Bamberg




Germany






Diclofenac sodium


Myogit 100


100 mg


Suppository


Rectal use




Germany







Dr. R. Pfleger Chemische Fabrik GmbH




Dr.Robert Pfleger Strasse 12




D-96045 Bamberg




Germany






Diclofenac sodium


Myogit 25


25 mg


Gastro-resistant tablet


Oral use




Germany







Dr. R. Pfleger Chemische Fabrik GmbH




Dr.Robert Pfleger Strasse 12




D-96045 Bamberg




Germany






Diclofenac sodium


Myogit 50


50 mg


Gastro-resistant tablet


Oral use




Germany







Dr. Kade Pharmazeutische Fabrik GmbH




Rigistr. 2




12277 Berlin




Germany






Diclofenac sodium


Diclo KD 100


100 mg


Suppository


Rectal use




Germany







Dr. Kade Pharmazeutische Fabrik GmbH




Rigistr. 2




12277 Berlin




Germany






Diclofenac sodium


Diclo KD 50


50 mg


Suppository


Rectal use




Germany







Dr. Kade Pharmazeutische Fabrik GmbH




Rigistr. 2




12277 Berlin




Germany






Diclofenac sodium


Diclo KD 50


50 mg


Gastro-resistant tablet


Oral use




Germany







Dr. Kade Pharmazeutische Fabrik GmbH




Rigistr. 2




12277 Berlin




Germany






Diclofenac sodium


Diclo KD 75 akut


75 mg


Modified-release capsule, hard


Oral use




Germany







Dr. Kade Pharmazeutische Fabrik GmbH




Rigistr. 2




12277 Berlin




Germany






Diclofenac sodium


Diclo KD retard


100 mg


Prolonged-release tablet


Oral use




Germany







hameln pharma plus gmbh




Langes Feld 13




31789 Hameln




Germany






Diclofenac sodium


Diclo-Weimer


75 mg


Solution for injection


Intramuscular use




Germany







Hermes Arzneimittel GmbH




Georg-Kalb-Str. 5-8




82049 Großhesselohe




Germany






Diclofenac sodium


Diclofenac Natrium HERMES 25 mg Brausetabletten


25 mg


Effervescent tablet


Oral use




Germany







Hermes Arzneimittel GmbH




Georg-Kalb-Str. 5-8




82049 Großhesselohe




Germany






Diclofenac sodium


Diclofenac Natrium HERMES 50 mg Brausetabletten


50 mg


Effervescent tablet


Oral use




Germany







Heumann Pharma GmbH & Generica Co. KG




Südwestpark 50




90449 Nürnberg




Germany






Diclofenac sodium


Diclofenac 100 Heumann Supp.


100 mg


Suppository


Rectal use




Germany







Heumann Pharma GmbH & Generica Co. KG




Südwestpark 50




90449 Nürnberg




Germany






Diclofenac sodium


Diclofenac 100 retard Heumenn


100 mg


Prolonged-release tablet


Oral use




Germany







Heumann Pharma GmbH & Generica Co. KG




Südwestpark 50




90449 Nürnberg




Germany






Diclofenac sodium


Diclofenac 25 Heumenn


25 mg


Gastro-resistant tablet


Oral use




Germany







Heumann Pharma GmbH & Generica Co. KG




Südwestpark 50




90449 Nürnberg




Germany






Diclofenac sodium


Diclofenac 50 Heumann


50 mg


Gastro-resistant tablet


Oral use




Germany







Heumann Pharma GmbH & Generica Co. KG




Südwestpark 50




90449 Nürnberg




Germany






Diclofenac sodium


Diclofenac 50 Heumenn Supp.


50 mg


Suppository


Rectal use




Germany







Hexal AG




Industriestraße 25




D-83607 Holzkirchen




Germany






Diclofenac sodium


Diclac


75 mg


Solution for injection


Intramuscular use




Germany







Hexal AG




Industriestraße 25




D-83607 Holzkirchen




Germany






Diclofenac sodium


Diclac 100 mg Zäpfchen


100 mg


Suppository


Rectal use




Germany







Hexal AG




Industriestraße 25




D-83607 Holzkirchen




Germany






Diclofenac sodium


Diclac 150 mg ID


150 mg


Prolonged-release tablet


Oral use




Germany







Hexal AG




Industriestraße 25




D-83607 Holzkirchen




Germany






Diclofenac sodium


Diclac 25


25 mg


Gastro-resistant tablet


Oral use




Germany







Hexal AG




Industriestraße 25




D-83607 Holzkirchen




Germany






Diclofenac sodium


Diclac 50


50 mg


Gastro-resistant tablet


Oral use




Germany







Hexal AG




Industriestraße 25




D-83607 Holzkirchen




Germany






Diclofenac sodium


Diclac 50 mg Zäpfchen


50 mg


Suppository


Rectal use




Germany







Hexal AG




Industriestraße 25




D-83607 Holzkirchen




Germany






Diclofenac sodium


Diclac 75 mg ID


75 mg


Prolonged-release tablet


Oral use




Germany







Hexal AG




Industriestraße 25




D-83607 Holzkirchen




Germany






Diclofenac sodium


Diclac Dispers


50 mg


dispersible tablet


Oral use




Germany







Hexal AG




Industriestraße 25




D-83607 Holzkirchen




Germany






Diclofenac potassium


Diclac Dolo 12,5 mg


12,5 mg


Film-coated tablet


Oral use




Germany







Hexal AG




Industriestraße 25




D-83607 Holzkirchen




Germany






Diclofenac potassium


Diclac Dolo 25 mg


25 mg


Coated tablet


Oral use




Germany







Hexal AG




Industriestraße 25




D-83607 Holzkirchen




Germany






Diclofenac sodium


Diclac retard


100 mg


Prolonged-release tablet


Oral use




Germany







HIKMA Farmaceutica (Portugal), S.A.




Estrada do Rio da Mo, 8, 8 A e 8 B - Fervenca




2705-906 Terrugem SNT




Portugal






Diclofenac sodium


Diclofenac Hikma 75 mg


75 mg


Solution for injection


Intramuscular use




Germany







Juta Pharma GmbH




Gutenbergstr. 13




24941 Flensburg




Germany






Diclofenac sodium


Jutafenac 100 mg Retardtabletten


100 mg


Prolonged-release tablet


Oral use




Germany







Kappler Pharma Consult GmbH




Fonyoder Str. 18




89340 Leipheim




Germany






Diclofenac potassium


Diclofen Kalium KPC 25 mg Filmtabletten


25 mg


Film-coated tablet


Oral use




Germany







KSK-Pharma Vertriebs AG




Finkenstr. 1




76327 Pfinztal-Berghausen




Germany






Diclofenac sodium


Diclo KSK 50 mg


50 mg


Gastro-resistant tablet


Oral use




Germany







MEDA Pharma GmbH & Co. KG




Benzstr. 1




61352 Bad Homburg




Germany






Diclofenac sodium


Diclofenac MEDA 25 mg Brausetabletten


25 mg


Effervescent tablet


Oral use




Germany







MEDA Pharma GmbH & Co. KG




Benzstr. 1




61352 Bad Homburg




Germany






Diclofenac sodium


Diclofenac MEDA 50 mg Brausetabletten


50 mg


Effervescent tablet


Oral use




Germany







Mylan dura GmbH




Wittichstr. 6




64295 Darmstadt




Germany






Diclofenac sodium


Diclofenac dura 100 mg Retardtabletten


100 mg


Prolonged-release tablet


Oral use




Germany







Mylan dura GmbH




Wittichstr. 6




64295 Darmstadt




Germany






Diclofenac sodium


Diclofenac dura 100 mg Zäpfchen


100 mg


Suppository


Rectal use




Germany







Mylan dura GmbH




Wittichstr. 6




64295 Darmstadt




Germany






Diclofenac sodium


Diclofenac dura 25 mg


25 mg


Gastro-resistant tablet


Oral use




Germany







Mylan dura GmbH




Wittichstr. 6




64295 Darmstadt




Germany






Diclofenac sodium


Diclofenac dura 50 mg


50 mg


Gastro-resistant tablet


Oral use




Germany







Mylan dura GmbH




Wittichstr. 6




64295 Darmstadt




Germany






Diclofenac sodium


Diclofenac Mylan 100 mg Retardtabletten


100 mg


Prolonged-release tablet


Oral use




Germany







Novartis Consumer Health GmbH




Zielstattstrasse 40




81379 München




Germany






Diclofenac potassium


Diclofenac NCH 25 mg


25 mg


Coated tablet


Oral use




Germany







Novartis Consumer Health GmbH




Zielstattstrasse 40




81379 München




Germany






Diclofenac potassium


Optalidon Zahnschmerz mit Diclofenac 25 mg


25 mg


Coated tablet


Oral use




Germany







Novartis Consumer Health GmbH




Zielstattstrasse 40




81379 München




Germany






Diclofenac potassium


Voltaren Dolo 12,5 mg


12,5 mg


Film-coated tablet


Oral use




Germany







Novartis Consumer Health GmbH




Zielstattstrasse 40




81379 München




Germany






Diclofenac potassium


Voltaren Dolo 25 mg


25 mg


Coated tablet


Oral use




Germany







Novartis Consumer Health GmbH




Zielstattstrasse 40




81379 München




Germany






Diclofenac potassium


Voltaren Dolo 25 mg


25 mg


Coated tablet


Oral use




Germany







Novartis Consumer Health GmbH




Zielstattstrasse 40




81379 München




Germany






Diclofenac potassium


Voltaren Dolo Liquid 12,5 mg


12,5 mg


Capsule, soft


Oral use




Germany







Novartis Pharma GmbH




Roonstrasse 25




90426 Nuernberg




Germany






Diclofenac sodium
Codein phosphate hemihydrate


Combaren 50 mg/50 mg Filmtabletten


50 mg
50 mg


Film-coated tablet


Oral use




Germany







Novartis Pharma GmbH




Roonstrasse 25




90426 Nuernberg




Germany






Diclofenac sodium


Voltaren 100 mg retard


100 mg


Prolonged-release tablet


Oral use




Germany







Novartis Pharma GmbH




Roonstrasse 25




90426 Nuernberg




Germany






Diclofenac sodium


Voltaren 100 mg Zäpfchen


100 mg


Suppository


Rectal use




Germany







Novartis Pharma GmbH




Roonstrasse 25




90426 Nuernberg




Germany






Diclofenac sodium


Voltaren 25 mg


25 mg


Gastro-resistant tablet


Oral use




Germany







Novartis Pharma GmbH




Roonstrasse 25




90426 Nuernberg




Germany






Diclofenac sodium


Voltaren 25 mg Zäpfchen


25 mg


Suppository


Rectal use




Germany







Novartis Pharma GmbH




Roonstrasse 25




90426 Nuernberg




Germany






Diclofenac sodium


Voltaren 50 mg


50 mg


Gastro-resistant tablet


Oral use




Germany







Novartis Pharma GmbH




Roonstrasse 25




90426 Nuernberg




Germany






Diclofenac sodium


Voltaren 50 mg Zäpfchen


50 mg


Suppository


Rectal use




Germany







Novartis Pharma GmbH




Roonstrasse 25




90426 Nuernberg




Germany






Diclofenac sodium


Voltaren Dispers


50 mg


Dispersible tablet


Oral use




Germany







Novartis Pharma GmbH




Roonstrasse 25




90426 Nuernberg




Germany






Diclofenac potassium


Voltaren K Migräne 50 mg


50 mg


Coated tablet


Oral use




Germany







Novartis Pharma GmbH




Roonstrasse 25




90426 Nuernberg




Germany






Diclofenac sodium
Codeine phosphate hemihydrate


Voltaren Plus 50 mg/50 mg Filmtabletten


50 mg
50 mg


Film-coated tablet


Oral use




Germany







Novartis Pharma GmbH




Roonstrasse 25




90426 Nuernberg




Germany






Diclofenac colestyramin


Voltaren Resinat


140 mg


Capsule, hard


Oral use




Germany







Pharmacia GmbH




Linkstrasse 10




10785 Berlin




Germany






Diclofenac sodium
Misoprostol


Arthotec


50 mg
0,2 mg


Coated tablet


Oral use




Germany







Pharmacia GmbH




Linkstrasse 10




10785 Berlin




Germany






Diclofenac sodium
Misoprostol


Arthotec forte


75 mg
0,2 mg


Coated tablet


Oral use




Germany







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac sodium


Diclofenac-ratiopharm 100 mg Zäpfchen


100 mg


Suppository


Rectal use




Germany







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac sodium


Diclofenac-ratiopharm 100 mg Retardkapseln


100 mg


Prolonged-release capsule


Oral use




Germany







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac sodium


Diclofenac-ratiopharm 25 mg magensaftresistente Tabletten


25 mg


Gastro-resistant tablet


Oral use




Germany







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac sodium


Diclofenac-ratiopharm 50 mg Disperstabletten


50 mg


Dispersible tablet


Oral use




Germany







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac sodium


Diclofenac-ratiopharm 50 mg magensaftresistente Tabletten


50 mg


Gastro-resistant tablet


Oral use




Germany







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac sodium


Diclofenac-ratiopharm 50 mg Zäpfchen


50 mg


Suppository


Rectal use




Germany







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac sodium


Diclofenac-ratiopharm 75 mg SL Retardkapseln


75 mg


Prolonged-release capsule


Oral use




Germany







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac sodium


Diclofenac-ratiopharm 75 mg/2 ml Injektionslösung


75 mg/2 ml


Solution for injection


Intramuscular use




Germany







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac potassium


Diclofenac-ratiopharm Lösung bei Migräne


50 mg/1 ml


Oral drops, solution


Oral use




Germany







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac potassium


Diclofenac-ratiopharm Schmerztabletten 12,5 mg


12,5 mg


Film-coated tablet


Oral use




Germany







Rotexmedica GmbH Arzneimittelwerk




Bunsenstr. 4




22946 Trittau




Germany






Diclofenac sodium


Diclofenac SF-Rotexmedica


75 mg/3 ml


Solution for injection


Intramuscular use




Germany







Sandoz Pharmaceuticals GmbH




Raiffeisenstr. 11




83607 Holzkirchen




Germany






Diclofenac sodium


Diclofenac Sandoz 100 mg Retardtabletten


100 mg


Prolonged-release tablet


Oral use




Germany







Sandoz Pharmaceuticals GmbH




Raiffeisenstr. 11




83607 Holzkirchen




Germany






Diclofenac sodium


Diclofenac Sandoz 100 mg Zäpfchen


100 mg


Suppository


Rectal use




Germany







Sandoz Pharmaceuticals GmbH




Raiffeisenstr. 11




83607 Holzkirchen




Germany






Diclofenac sodium


Diclofenac Sandoz 25 mg magensaftresistente Tabletten


25 mg


Gastro-resistant tablet


Oral use




Germany







Sandoz Pharmaceuticals GmbH




Raiffeisenstr. 11




83607 Holzkirchen




Germany






Diclofenac sodium


Diclofenac Sandoz 50 mg magensaftresistente Tabletten


50 mg


Gastro-resistant tablet


Oral use




Germany







Sandoz Pharmaceuticals GmbH




Raiffeisenstr. 11




83607 Holzkirchen




Germany






Diclofenac sodium


Diclofenac Sandoz 50 mg Zäpfchen


50 mg


Suppository


Rectal use




Germany







Sandoz Pharmaceuticals GmbH




Raiffeisenstr. 11




83607 Holzkirchen




Germany






Diclofenac sodium


Diclofenac Sandoz parenteral 75 mg Injektionslösung


75 mg


Solution for injection


Intramuscular use




Germany







Sandoz Pharmaceuticals GmbH




Raiffeisenstr. 11




83607 Holzkirchen




Germany






Diclofenac sodium


Diclofenac Sandoz Uno 150 mg Retardtabletten


150 mg


Prolonged-release tablet


Oral use




Germany







sigapharm GmbH




Temmlerstr. 2




35039 Marburg/Lahn




Germany






Diclofenac sodium


Sigafenac 50 mg Zäpfchen


50 mg


Suppository


Rectal use




Germany







Stadapharm GmbH




Stadastr. 2-18




61118 Bad Vilbel




Germany






Diclofenac sodium


Diclofenac STADA 100 mg Retardtabletten


100 mg


Prolonged-release tablet


Oral use




Germany







Stadapharm GmbH




Stadastr. 2-18




61118 Bad Vilbel




Germany






Diclofenac sodium


Diclofenac STADA 100 mg Zäpfchen


100 mg


Suppository


Rectal use




Germany







Stadapharm GmbH




Stadastr. 2-18




61118 Bad Vilbel




Germany






Diclofenac sodium


Diclofenac STADA 25 mg magensaftresistente Tabletten


25 mg


Gastro-resistant tablet


Oral use




Germany







Stadapharm GmbH




Stadastr. 2-18




61118 Bad Vilbel




Germany






Diclofenac sodium


Diclofenac STADA 50 mg magensaftresistente Tabletten


50 mg


Gastro-resistant tablet


Oral use




Germany







Stadapharm GmbH




Stadastr. 2-18




61118 Bad Vilbel




Germany






Diclofenac sodium


Diclofenac Stada 50 mg Zäpfchen


50 mg


Suppository


Rectal use




Germany







Stadapharm GmbH




Stadastr. 2-18




61118 Bad Vilbel




Germany






Diclofenac sodium


Diclofenac STADA N 75 mg/3 ml Injektionslösung


75 mg/3 ml


Solution for injection


Intramuscular use




Germany







Stadapharm GmbH




Stadastr. 2-18




61118 Bad Vilbel




Germany






Diclofenac potassium


Diclofenac-Kalium STADA 12,5 mg Filmtabletten


12,5 mg


Film-coated tablet


Oral use




Germany







Stadapharm GmbH




Stadastr. 2-18




61118 Bad Vilbel




Germany






Diclofenac potassium


Diclofenac-Kalium STADA 25 mg Filmtabletten


25 mg


Film-coated tablet


Oral use




Germany







T & D Pharma GmbH




Kleine Knopheide 4




32657 Lemgo




Germany






Diclofenac sodium


Allvoran 100 mg Retard


100 mg


Prolonged-release tablet


Oral use




Germany







T & D Pharma GmbH




Kleine Knopheide 4




32657 Lemgo




Germany






Diclofenac sodium


Allvoran SF


75 mg/3 ml


Solution for injection


Intramuscular use




Germany







TAD Pharma GmbH




Heinz-Lohmann-Str. 5




27472 Cuxhaven




Germany






Diclofenac sodium


Allvoran 25 mg


25 mg


Gastro-resistant tablet


Oral use




Germany







TAD Pharma GmbH




Heinz-Lohmann-Str. 5




27472 Cuxhaven




Germany






Diclofenac sodium


Allvoran 50 mg


50 mg


Gastro-resistant tablet


Oral use




Germany







TAD Pharma GmbH




Heinz-Lohmann-Str. 5




27472 Cuxhaven




Germany






Diclofenac sodium


Allvoran S 100 mg


100 mg


Suppository


Rectal use




Germany







TAD Pharma GmbH




Heinz-Lohmann-Str. 5




27472 Cuxhaven




Germany






Diclofenac sodium


Allvoran S 50 mg


50 mg


Suppository


Rectal use




Germany







TAD Pharma GmbH




Heinz-Lohmann-Str. 5




27472 Cuxhaven




Germany






Diclofenac sodium


Allvoran uno


100 mg


Prolonged-release tablet


Oral use




Germany







Temmler Werke GmbH




Weihenstephaner Str. 28




81673 München




Germany






Diclofenac sodium


Diclo-Klinge 75 mg magensaftresistente Hartkapsel


75 mg


Prolonged-release capsule, hard


Oral use




Germany







Temmler Werke GmbH




Weihenstephaner Str. 28




81673 München




Germany






Diclofenac sodium


Diclo-Klinge 75 mg spezial


75 mg


Prolonged-release capsule, hard


Oral use




Germany







Temmler Werke GmbH




Weihenstephaner Str. 28




81673 München




Germany






Diclofenac sodium


Diclofenac spezial 100 mg Klinge


100 mg


Prolonged-release capsule, hard


Oral use




Germany







Temmler Werke GmbH




Weihenstephaner Str. 28




81673 München




Germany






Diclofenac sodium


Diclofenac spezial 75 mg Klinge


75 mg


Prolonged-release capsule, hard


Oral use




Germany







Temmler Werke GmbH




Weihenstephaner Str. 28




81673 München




Germany






Diclofenac sodium


Diclofenac Temmler 25 mg Hartkapseln


25 mg


Gastro-resistant capsule, hard


Oral use




Germany







Temmler Werke GmbH




Weihenstephaner Str. 28




81673 München




Germany






Diclofenac sodium


Diclofenac Temmler SL 100 mg Retardkapseln


100 mg


Prolonged-release capsule


Oral use




Germany







Temmler Werke GmbH




Weihenstephaner Str. 28




81673 München




Germany






Diclofenac sodium


Diclofenac Temmler SL 75 mg Retardkapseln


75 mg


Prolonged-release capsule


Oral use




Germany







TEOFARMA S.R.L.




Via F.Iii Cervi 8




I-27010 VALLE SALIMBENE (PV)




Italy






Diclofenac sodium


Effekton 100 mg Retardtabletten


100 mg


Prolonged-release tablet


Oral use




Germany







TEOFARMA S.R.L.




Via F.Iii Cervi 8




I-27010 VALLE SALIMBENE (PV)




Italy






Diclofenac sodium


Effekton 100 mg Zäpfchen


100 mg


Suppository


Rectal use




Germany







TEOFARMA S.R.L.




Via F.Iii Cervi 8




I-27010 VALLE SALIMBENE (PV)




Italy






Diclofenac sodium


Effekton 25 mg magensaftresistente Tabletten


25 mg


Gastro-resistant tablet


Oral use




Germany







TEOFARMA S.R.L.




Via F.Iii Cervi 8




I-27010 VALLE SALIMBENE (PV)




Italy






Diclofenac sodium


Effekton 50 mg magensaftresistente Tabletten


50 mg


Gastro-resistant tablet


Oral use




Germany







TEOFARMA S.R.L.




Via F.Iii Cervi 8




I-27010 VALLE SALIMBENE (PV)




Italy






Diclofenac sodium


Effekton 75 mg/3 ml Injektionslösung


75 mg/3 ml


Solution for injection


Intramuscular use




Germany







TEVA GmbH




Graf-Arco-Str. 3




89079 Ulm




Germany






Diclofenac sodium


Xelaran Brausetablette 25 mg


25 mg


Effervescent tablet


Oral use




Germany







Vitabalans OY




Varastokatu 8




FI-135 000 Hämeenlinna




Finland






Diclofenac potassium


Diclotin 25 mg Filmtabletten


25 mg


Film-coated tablet


Oral use




Germany







Vitabalans OY




Varastokatu 8




FI-135 000 Hämeenlinna




Finland






Diclofenac potassium


Diclotin 50 mg Filmtabletten


50 mg


Film-coated tablet


Oral use




Germany







Walter Ritter GmbH & Co.




Spaldingstr. 110 B




20097 Hamburg




Germany






Diclofenac sodium


Diclowal 100 mg retard


100 mg


Prolonged-release tablet


Oral use




Germany







Walter Ritter GmbH & Co.




Spaldingstr. 110 B




20097 Hamburg




Germany






Diclofenac sodium


DICLOWAL 50


50 mg


Gastro-resistant tablet


Oral use




Germany







Walter Ritter GmbH & Co.




Spaldingstr. 110 B




20097 Hamburg




Germany






Diclofenac sodium


DICLOWAL 75 mg


75 mg


Solution for injection


Intramuscular use




Germany







Walter Ritter GmbH & Co.




Spaldingstr. 110 B




20097 Hamburg




Germany






Diclofenac sodium


DICLOWAL Supp.


100 mg


Suppository


Rectal use




Germany







Winthrop Arzneimittel GmbH




Urmitzer Str. 5




56218 Mülheim-Kärlich




Germany






Diclofenac sodium


Monoflam 100 mg


100 mg


Suppository


Rectal use




Germany







Winthrop Arzneimittel GmbH




Urmitzer Str. 5




56218 Mülheim-Kärlich




Germany






Diclofenac sodium


Monoflam 50 mg


50 mg


Gastro-resistant tablet


Oral use




Germany







Winthrop Arzneimittel GmbH




Urmitzer Str. 5




56218 Mülheim-Kärlich




Germany






Diclofenac sodium


Monoflam 50 mg


50 mg


Suppository


Rectal use




Germany







Winthrop Arzneimittel GmbH




Urmitzer Str. 5




56218 Mülheim-Kärlich




Germany






Diclofenac sodium


Monoflam retard N


100 mg


Prolonged-release capsule, hard


Oral use




Germany







Wörwag Pharma GmbH & Co.KG




Calwer Str. 7




71034 Böblingen




Germany






Diclofenac sodium


Dignofenac 100 mg


100 mg


Prolonged-release tablet


Oral use




Germany







Wörwag Pharma GmbH & Co.KG




Calwer Str. 7




71034 Böblingen




Germany






Diclofenac sodium


Dignofenac 25 mg


25 mg


Gastro-resistant tablet


Oral use




Germany







Wörwag Pharma GmbH & Co.KG




Calwer Str. 7




71034 Böblingen




Germany






Diclofenac sodium


Dignofenac 50 mg


50 mg


Gastro-resistant tablet


Oral use




Greece







PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS




Dilou 9, Peristeri




Attikis, 12134




Greece






Diclofenac sodium


BATAFIL


75 mg/3 ml


Solution for injection


Intramuscular use, Intravenous use




Greece







NOVARTIS (HELLAS) A.E.B.E.




12th Km National Highway No 1,




Metamorfosi Attikis 144 51




Greece






Diclofenac sodium


VOLTAREN


75 mg/3 ml


Solution for injection


Intramuscular use, Intravenous use




Greece







PHARMATHEN International S.A. Greece




Dervenakiwn 4, Pallini




Attikis 15351




Greece






Diclofenac sodium


DELIMON


75 mg/3 ml


Solution for injection


Intramuscular use, Intravenous use




Greece







HELP ABEE




Valaoritou 10




Metamorfosi




Attikis, 14452




Greece






Diclofenac sodium


VURDON


75 mg/3 ml


Solution for injection


Intramuscular use, Intravenous use




Greece







BROS EPE




Avgis & Gallinis 15




N. Kifissia, 14564




Greece






Diclofenac sodium


EVINOPON


75 mg/3 ml


Solution for injection


Intramuscular use, Intravenous use




Greece







DEMO ABEE




21ST Km National Highway




Athens-Lamia, 14565




Greece






Diclofenac sodium


URIGON


75 mg/3 ml


Solution for injection


Intramuscular use, Intravenous use




Greece







RAFARM AEBE




Korinthou 12




N. Psychiko, 15451




Greece






Diclofenac sodium


RUVOMINOX


75 mg/3 ml


Solution for injection


Intramuscular use, Intravenous use




Greece







ANGELINI PHARMA HELLAS S.A. of Manufacturing and Commerce of Medicines




Achaias & Trizinias




Nea Kifissia 14564




Greece






Diclofenac sodium


RHEUMAVEK


75 mg/3 ml


Solution for injection


Intramuscular use, Intravenous use




Greece







MEDICUS S.A




Valaoritou 10




Metamorfosi 14452




Greece






Diclofenac sodium


DIFEND


75 mg/3 ml


Solution for injection


Intramuscular use, Intravenous use




Greece







NOVARTIS (HELLAS) A.E.B.E.




12th Km National Highway No 1,




Metamorfosi Attikis 144 51




Greece






Diclofenac sodium


VOLTAREN


25 mg


Enteric film-coated tablet


Oral use




Greece







NOVARTIS (HELLAS) A.E.B.E.




12th Km National Highway No 1,




Metamorfosi Attikis 144 51




Greece






Diclofenac sodium


VOLTAREN


50 mg


(Enteric coated) gastroresistant tablet


Oral use




Greece







NOVARTIS (HELLAS) A.E.B.E.




12th Km National Highway No 1,




Metamorfosi Attikis 144 51




Greece






Diclofenac sodium


VOLTAREN


100 mg


Film-coated sustained release tablet


Oral use




Greece







NOVARTIS (HELLAS) A.E.B.E.




12th Km National Highway No 1,




Metamorfosi Attikis 144 51




Greece






Diclofenac sodium


VOLTAREN


75 mg


Film-coated sustained release tablet


Oral use




Greece







NOVARTIS (HELLAS) A.E.B.E.




12th Km National Highway No 1,




Metamorfosi Attikis 144 51




Greece






Diclofenac sodium


VOLTAREN


50 mg


Dispersible tablet


Oral use




Greece







PHARMATHEN International S.A. Greece




Dervenakiwn 4, Pallini




Attikis 15351




Greece






Diclofenac sodium


DELIMON


25 mg


(Enteric coated) gastroresistant tablet


Oral use




Greece







PHARMATHEN International S.A. Greece




Dervenakiwn 4, Pallini




Attikis 15351




Greece






Diclofenac sodium


DELIMON


50 mg


(Enteric coated) gastroresistant tablet


Oral use




Greece







D.A.S.T. BIOTECH Pharmaceutical Ltd




Larissis 10




Pallini 15351




Greece






Diclofenac sodium


FLEFARMIN


50 mg


(Enteric coated) gastroresistant tablet


Oral use




Greece







HELP ABEE




Valaoritou 10




Metamorfosi




Attikis, 14452




Greece






Diclofenac sodium


VURDON


25 mg


(Enteric coated) gastroresistant tablet


Oral use




Greece







HELP ABEE




Valaoritou 10




Metamorfosi




Attikis, 14452




Greece






Diclofenac sodium


VURDON


100 mg


Film-coated sustained release tablet


Oral use




Greece







BROS EPE




Avgis & Gallinis 15




N. Kifissia, 14564




Greece






Diclofenac sodium


EVINOPON


25 mg


(Enteric coated) gastroresistant tablet


Oral use




Greece







BROS EPE




Avgis & Gallinis 15




N. Kifissia, 14564




Greece






Diclofenac sodium


EVINOPON


50 mg


(Enteric coated) gastroresistant tablet


Oral use




Greece







DEMO ABEE




21ST Km National Highway




Athens-Lamia, 14565




Greece






Diclofenac sodium


URIGON


25 mg


(Enteric coated) gastroresistant tablet


Oral use




Greece







DEMO ABEE




21ST Km National Highway




Athens-Lamia, 14565




Greece






Diclofenac sodium


URIGON


50 mg


(Enteric coated) gastroresistant tablet


Oral use




Greece







RAFARM AEBE




Korinthou 12




N. Psychiko, 15451




Greece






Diclofenac sodium


RUVOMINOX


50 mg


Coated tablet


Oral use




Greece







RAFARM AEBE




Korinthou 12




N. Psychiko, 15451




Greece






Diclofenac sodium


RUVOMINOX


25 mg


Coated tablet


Oral use




Greece







ANGELINI PHARMA HELLAS S.A. of Manufacturing and Commerce of Medicines




Achaias & Trizinias




Nea Kifissia 14564




Greece






Diclofenac sodium


RHEUMAVEK


25 mg


(Enteric coated) gastroresistant tablet


Oral use




Greece







ANGELINI PHARMA HELLAS S.A. of Manufacturing and Commerce of Medicines




Achaias & Trizinias




Nea Kifissia 14564




Greece






Diclofenac sodium


RHEUMAVEK


50 mg


(Enteric coated) gastroresistant tablet


Oral use




Greece







Pfizer Hellas A.E.




Messoghion Ave. 243




Neo Psychiko 15451




Greece






Diclofenac sodium
Misoprostol


ARTHROTEC


50 mg
0,2 mg


Controlled release tablet


Oral use




Greece







PHARMANEL COMMERCE PHARMACEUTICAL S.A.




Marathonos Avenue 106, Gerakas 15344




Greece






Diclofenac sodium


FENOCLOF


75 mg


Controlled release capsule


Oral use




Greece







NOVARTIS (HELLAS) A.E.B.E.




12th Km National Highway No 1,




Metamorfosi Attikis 144 51




Greece






Diclofenac potassium


VOLTAREN ACTI-GO


25 mg


Coated tablet


Oral use




Greece







NOVARTIS (HELLAS) A.E.B.E.




12th Km National Highway No 1,




Metamorfosi Attikis 144 51




Greece






Diclofenac potassium


VOLTAREN ACTI-GO


50 mg


Coated tablet


Oral use




Greece







NOVARTIS (HELLAS) A.E.B.E.




12th Km National Highway No 1,




Metamorfosi Attikis 144 51




Greece






Diclofenac potassium


VOLTAREN ACTI-GO


12,5 mg


Coated tablet


Oral use




Greece







NOVARTIS (HELLAS) A.E.B.E.




12th Km National Highway No 1,




Metamorfosi Attikis 144 51




Greece






Diclofenac potassium


VOLTAREN FAST


50 mg


Powder for oral solution


Oral use




Greece







PHARMASWISS HELLAS A.E.




Pentelis Avenue 53




Vrilissia 15235




Greece






Diclofenac sodium


DICLO DUO


75 mg


Controlled release capsule


Oral use




Greece







PHARMASWISS HELLAS A.E.




Pentelis Avenue 53




Vrilissia 15235




Greece






Diclofenac sodium


COUNTERFLAME


75 mg


Gastro-resistant capsule


Oral use




Greece







NOVARTIS (HELLAS) A.E.B.E.




12th Km National Highway No 1,




Metamorfosi Attikis 144 51




Greece






Diclofenac sodium


VOLTAREN


50 mg


Suppository


Rectal use




Greece







NOVARTIS (HELLAS) A.E.B.E.




12th Km National Highway No 1,




Metamorfosi Attikis 144 51




Greece






Diclofenac sodium


VOLTAREN


100 mg


Suppository


Rectal use




Greece







HELP ABEE




Valaoritou 10




Metamorfosi




Attikis, 14452




Greece






Diclofenac sodium


VURDON


50 mg


Suppository


Rectal use




Greece







HELP ABEE




Valaoritou 10




Metamorfosi




Attikis, 14452




Greece






Diclofenac sodium


VURDON


100 mg


Suppository


Rectal use




Greece







BROS EPE




Avgis & Gallinis 15




N. Kifissia, 14564




Greece






Diclofenac sodium


EVINOPON


50 mg


Suppository


Rectal use




Greece







RAFARM AEBE




Korinthou 12




N. Psychiko, 15451




Greece






Diclofenac sodium


RUVOMINOX


50 mg


Suppository


Rectal use




Hungary







Novartis Hungária Kft. Pharma részlege




Bartók Béla út 43-47.




Budapest, 1114




Hungary






Diclofenac


CATAFLAM belsőleges szuszpenziós cseppek


15 mg/ml


Oral drops, suspension


Oral use




Hungary







Novartis Hungária Kft. Pharma részlege




Bartók Béla út 43-47.




Budapest, 1114




Hungary






Diclofenac


CATAFLAM 50 mg bevont tabletta


50 mg


Coated tablet


Oral use




Hungary







Novartis Hungária Kft. Pharma részlege




Bartók Béla út 43-47.




Budapest, 1114




Hungary






Diclofenac


CATAFLAM-V 50 mg tabletta


50 mg


Tablet


Oral use




Hungary







Sandoz Hungária Kft.,




Bartók Béla út 43.-47.




Budapest, 1114




Hungary






Diclofenac


DICLAC 75 mg retard tabletta


75 mg


Prolonged-release tablet


Oral use




Hungary







Sandoz Hungária Kft.,




Bartók Béla út 43.-47.




Budapest, 1114




Hungary






Diclofenac


DICLAC 150 mg retard tabletta


150 mg


Prolonged-release tablet


Oral use




Hungary







ALIUD PHARMA GmbH & Co. KG




Gottlieb Daimler Strasse 19




D-89150 Laichingen




Germany






Diclofenac


DICLOFENAC AL 50 mg végbélkúp


50 mg


Suppository


Rectal use




Hungary







ALIUD PHARMA GmbH & Co. KG




Gottlieb Daimler Strasse 19




D-89150 Laichingen




Germany






Diclofenac


DICLOFENAC AL 50 mg gyomornedv-ellenálló filmtabletta


50 mg


Gastro-resistant film-coated tablet


Oral use




Hungary







ALIUD PHARMA GmbH & Co. KG




Gottlieb Daimler Strasse 19




D-89150 Laichingen




Germany






Diclofenac


DICLOFENAC AL 100 mg végbélkúp


100 mg


Suppository


Rectal use




Hungary







ALIUD PHARMA GmbH & Co. KG




Gottlieb Daimler Strasse 19




D-89150 Laichingen




Germany






Diclofenac


DICLOFENAC AL 75 mg/3 ml oldatos injekció


75 mg/3 ml


Solution for injection


Parenteral use,
Intramuscular use




Hungary







PharmaSwiss Česká republika s.r.o.




Jankovcova 1569/2c




170 00 Praha 7 - Holešovice




Czech Republic






Diclofenac


DICLOFENAC DUO PHARMAVIT 75 mg kemény kapszula


75 mg


Capsule, hard


Oral use




Hungary







STADA Arzneimittel AG




Stadastrasse 2-18




Bad Vilbel 61118




Germany






Diclofenac


DICLOFENAC STADA 100 mg retard filmtabletta


100 mg


Prolonged-release film-coated tablet


Oral use




Hungary







ratiopharm Hungária




Kereskedelmi Kft. Uzsoki u. 36/a




Budapest, 1145




Hungary






Diclofenac


DICLOFENAC-RATIOPHARM 25 mg filmtabletta


25 mg


Film-coated tablet


Oral use




Hungary







ratiopharm Hungária




Kereskedelmi Kft. Uzsoki u. 36/a




Budapest, 1145




Hungary






Diclofenac


DICLOFENAC-RATIOPHARM 100 mg retard kemény kapszula


100 mg


Prolonged-release capsule, hard


Oral use




Hungary







ratiopharm Hungária




Kereskedelmi Kft. Uzsoki u. 36/a




Budapest, 1145




Hungary






Diclofenac


DICLOFENAC-RATIOPHARM 50 mg filmtabletta


50 mg


Film-coated tablet


Oral use




Hungary







ratiopharm Hungária




Kereskedelmi Kft. Uzsoki u. 36/a




Budapest, 1145




Hungary






Diclofenac


DICLOFENAC-RATIOPHARM retard tabletta


150 mg


Prolonged-release tablet


Oral use




Hungary







TEVA Gyógyszergyár zRt.




Pallagi út 13




Debrecen 4042




Hungary






Diclofenac


DICLOFENAC-TEVA 100 mg végbélkúp


100 mg


Suppository


Rectal use




Hungary







PANNONPHARMA Gyógyszergyártó Kft.




PannonPharma út 1.




Pécsvárad 7720




Hungary






Diclofenac


DICLOMEL SR 100 mg retard tabletta


100 mg


Prolonged-release tablet


Oral use




Hungary







Fresenius Kabi Austria GmbH




Hafnerstrasse 36




Graz A-8055




Austria






Diclofenac sodium
Orphenadrine citrate


NEODOLPASSE oldatos infúzió


75 mg/250 ml
30 mg/250 ml


Solution for infusion


Parenteral use,
Intravenous use




Hungary







Novartis Hungária Kft. Pharma részlege




Bartók Béla út 43-47.




Budapest, 1114




Hungary






Diclofenac


VOLTAREN 100 mg retard filmtabletta


100 mg


Prolonged-release film-coated tablet


Oral use




Hungary







Novartis Hungária Kft. Pharma részlege




Bartók Béla út 43-47.




Budapest, 1114




Hungary






Diclofenac


VOLTAREN 25 mg gyomornedv-ellenálló filmtabletta


25 mg


Gastro-resistant film-coated tablet


Oral use




Hungary







Novartis Hungária Kft. Pharma részlege




Bartók Béla út 43-47.




Budapest, 1114




Hungary






Diclofenac


VOLTAREN 50 mg gyomornedv-ellenálló filmtabletta


50 mg


Gastro-resistant film-coated tablet


Oral use




Hungary







Novartis Hungária Kft. Pharma részlege




Bartók Béla út 43-47.




Budapest, 1114




Hungary






Diclofenac


VOLTAREN 50 mg végbélkúp


50 mg


Suppository


Rectal use




Hungary







Novartis Hungária Kft. Pharma részlege




Bartók Béla út 43-47.




Budapest, 1114




Hungary






Diclofenac


VOLTAREN 75 mg retard filmtabletta


75 mg


Prolonged-release film-coated tablet


Oral use




Hungary







Novartis Hungária Kft. Pharma részlege




Bartók Béla út 43-47.




Budapest, 1114




Hungary






Diclofenac


VOLTAREN 75 mg/3 ml oldatos injekció


75 mg/3 ml


Solution for injection


Parenteral use; Intramuscular injection or intravenous infusion. Not applicable for bolus intravenous injection




Hungary







Novartis Hungária Kft. Pharma részlege




Bartók Béla út 43-47.




Budapest, 1114




Hungary






Diclofenac


VOLTAREN DOLO 12,5 mg filmtabletta


12,5 mg


Film-coated tablet


Oral use




Hungary







Novartis Hungária Kft. Pharma részlege




Bartók Béla út 43-47.




Budapest, 1114




Hungary






Diclofenac


VOLTAREN DOLO 12,5 mg lágy kapszula


12,5 mg


Capsule, soft


Oral use




Hungary







Novartis Hungária Kft. Pharma részlege




Bartók Béla út 43-47.




Budapest, 1114




Hungary






Diclofenac


VOLTAREN DOLO 25 mg bevont tabletta


25 mg


Coated tablet


Oral use




Hungary







Novartis Hungária Kft. Pharma részlege




Bartók Béla út 43-47.




Budapest, 1114




Hungary






Diclofenac potassium


VOLTAREN DOLO 25 mg lágy kapszula


25 mg


Capsule, soft


Oral use




Hungary







IBSA Pharma Információs és Szolgáltató Kft.




Fodor u. 54/B.




Budapest 1124,




Hungary






Diclofenac


FLECTOR RAPID 50 mg granulátum


50 mg


Granules


Oral use




Hungary







TEVA Gyógyszergyár zRt.




Pallagi út 13




Debrecen 4042




Hungary






Diclofenac


FORTEDOL 50 mg filmtabletta


50 mg


Film-coated tablet


Oral use




Iceland







Pfizer ApS




Lautrupvang 8




DK-2750 Ballerup




Denmark






Diclofenacum natrium
Misoprostolum


Arthrotec


50 mg
0,2 mg


Tablet


Oral use




Iceland







Pfizer ApS




Lautrupvang 8




DK-2750 Ballerup




Denmark






Diclofenacum natrium
Misoprostolum


Arthrotec Forte


75 mg
0,2 mg


Tablet


Oral use




Iceland







ratiopharm GmbH




Graf-Arco Strasse 3




89079 Ulm




Germany






Diclofenacum INN natríum


Diclomex


50 mg


Gastro-resistant tablet


Oral use




Iceland







Mylan AB




PO 230 33




Ynglingagatan 14




SE-104 35 Stockholm




Sweden






Diclofenacum natrium


Diklofenak Mylan


50 mg


Gastro-resistant tablet


Oral use




Iceland







Actavis Group PTC ehf




Reykjavikurvegi 76-78




IS-220 Hafnarfjördur




Iceæand






Diclofenacum natrium


Klofen L


100 mg


Prolonged-release capsule, hard


Oral use




Iceland







Actavis Group PTC ehf




Reykjavikurvegi 76-78




IS-220 Hafnarfjördur




Iceæand






Diclofenacum natrium


Modifenac


75 mg


Modified-release capsule, hard


Oral use




Iceland







Novaris Healthcare A/S




Lyngbyvej 172




DK-2100 Københawn Ø




Denmark






Diclofenacum natrium


Voltaren


100 mg


Suppository


Rectal use




Iceland







Novaris Healthcare A/S




Lyngbyvej 172




DK-2100 Københawn Ø




Denmark






Diclofenacum natrium


Voltaren


25 mg


Gastro-resistant tablet


Oral use




Iceland







Novaris Healthcare A/S




Lyngbyvej 172




DK-2100 Københawn Ø




Denmark






Diclofenacum natrium


Voltaren


25 mg/ml


Solution for injection


Intramuscular use




Iceland







Novaris Healthcare A/S




Lyngbyvej 172




DK-2100 Københawn Ø




Denmark






Diclofenacum natrium


Voltaren


50 mg


Suppository


Rectal use




Iceland







Novaris Healthcare A/S




Lyngbyvej 172




DK-2100 Københawn Ø




Denmark






Diclofenacum natrium


Voltaren


50 mg


Gastro-resistant tablet


Oral use




Iceland







Novaris Healthcare A/S




Lyngbyvej 172




DK-2100 Københawn Ø




Denmark






Diclofenacum kalium


Voltaren Dolo


12,5 mg


Film-coated tablet


Oral use




Iceland







Novaris Healthcare A/S




Lyngbyvej 172




DK-2100 Københawn Ø




Denmark






Diclofenacum kalium


Voltaren Dolo


12,5 mg


Capsule, soft


Oral use




Iceland







Novaris Healthcare A/S




Lyngbyvej 172




DK-2100 Københawn Ø




Denmark






Diclofenacum kalium


Voltaren Dolo


25 mg


Coated tablet


Oral use




Iceland







Novaris Healthcare A/S




Lyngbyvej 172




DK-2100 Københawn Ø




Denmark






Diclofenacum kalium


Voltaren Rapid


50 mg


Coated tablet


Oral use




Iceland







Actavis Group PTC ehf




Reykjavikurvegi 76-78




IS-220 Hafnarfjördur




Iceæand






Diclofenacum kalium


Vóstar-S


25 mg


Film-coated tablet


Oral use




Iceland







Actavis Group PTC ehf




Reykjavikurvegi 76-78




IS-220 Hafnarfjördur




Iceæand






Diclofenacum kalium


Vóstar-S


50 mg


Film-coated tablet


Oral use




Ireland







Novarits Pharmacetucials UK Ltd




Frimley Business Park




Frimley




Camberley, GU16 7SR




Surrey




United Kingdom






Diclofenac sodium


Voltarol 25 mg Gastro-Resistant Tablets


25 mg


Gastro-resistant tablet


Oral use




Ireland







Novarits Pharmacetucials UK Ltd




Frimley Business Park




Frimley




Camberley, GU16 7SR




Surrey




United Kingdom






Diclofenac sodium


Voltarol 50 mg Gastro-Resistant Tablets


50 mg


Gastro-resistant tablet


Oral use




Ireland







Novarits Pharmacetucials UK Ltd




Frimley Business Park




Frimley




Camberley, GU16 7SR




Surrey




United Kingdom






Diclofenac sodium


Voltarol 12,5 mg Suppositories


12,5 mg


Suppository


Rectal use




Ireland







Novarits Pharmacetucials UK Ltd




Frimley Business Park




Frimley




Camberley, GU16 7SR




Surrey




United Kingdom






Diclofenac sodium


Voltarol 100 mg Suppositories


100 mg


Suppository


Rectal use




Ireland







Novarits Pharmacetucials UK Ltd




Frimley Business Park




Frimley




Camberley, GU16 7SR




Surrey




United Kingdom






Diclofenac sodium


Voltarol Ampoules 75 mg/3 ml, solution for injection


75 mg/3 ml


Solution for injection


Intramuscular use




Ireland







Novarits Pharmacetucials UK Ltd




Frimley Business Park




Frimley




Camberley, GU16 7SR




Surrey




United Kingdom






Diclofenac sodium


Voltarol Retard 100 mg Film-coated Prolonged Release Tablets


100 mg


Film-coated prolonged release tablet


Oral use




Ireland







Novarits Pharmacetucials UK Ltd




Frimley Business Park




Frimley




Camberley, GU16 7SR




Surrey




United Kingdom






Diclofenac sodium


Voltarol Retard 75 mg Film-coated Prolonged-release Tablets


75 mg


Film-coated prolonged release tablet


Oral use




Ireland







Novarits Pharmacetucials UK Ltd




Frimley Business Park




Frimley




Camberley, GU16 7SR




Surrey




United Kingdom






Diclofenac potassium


Cataflam 25 mg Coated Tablets


25 mg


Coated tablet


Oral use




Ireland







Novarits Pharmacetucials UK Ltd




Frimley Business Park




Frimley




Camberley, GU16 7SR




Surrey




United Kingdom






Diclofenac potassium


Cataflam 50 mg Coated Tablets


50 mg


Coated tablet


Oral use




Ireland







Novarits Pharmacetucials UK Ltd




Frimley Business Park




Frimley




Camberley, GU16 7SR




Surrey




United Kingdom






Diclofenac potassium


Voltfast Sachets 50 mg Powder for Oral Solution


50 mg


Powder for oral solution


Oral use




Ireland







Novartis Consumer Health UK Limited




Park View, Riverside Way




Watchmoor Park, Camberley




Surrey GU15 3YL




United Kingdom






Diclofenac potassium


Diclofenac potassium NCH 12,5 mg Film-coated tablets


12,5 mg


Film-coated tablet


Oral use




Ireland







Novartis Consumer Health UK Limited




Park View, Riverside Way




Watchmoor Park, Camberley




Surrey GU15 3YL




United Kingdom






Diclofenac potassium


Otriflu 12,5 mg Film-coated Tablets


12,5 mg


Film-coated tablet


Oral use




Ireland







Pinewood Laboratories Ltd




(T/A Pinewood Heathcare) Ballymacarbry




Clonmel, Co. Tipperary




Ireland






Diclofenac sodium


Diclo 75 mg prolonged release tablets.


75 mg


Prolonged-release tablet


Oral use




Ireland







Rowex Ltd




Bantry, Co. Cork




Ireland






Diclofenac sodium


Diclac 75 mg Prolonged -Release Tablets


75 mg


Prolonged-release tablet


Oral use




Ireland







Rowex Ltd




Bantry, Co. Cork




Ireland






Diclofenac sodium


Diclac Retard 100 mg Prolonged-release Tablets


100 mg


Prolonged-release tablet


Oral use




Ireland







Rowex Ltd




Bantry, Co. Cork




Ireland






Diclofenac sodium


Diclac 25 mg Gastro-resistant Tablets


25 mg


Gastro-resistant tablet


Oral use




Ireland







Rowex Ltd




Bantry, Co. Cork




Ireland






Diclofenac sodium


Diclac 50 mg Gastro-resistant Tablets


50 mg


Gastro-resistant tablet


Oral use




Ireland







Rowex Ltd




Bantry, Co. Cork




Ireland






Diclofenac sodium


Diclac 100 mg Suppositories


100 mg


Suppository


Rectal use




Ireland







Rowex Ltd




Bantry, Co. Cork




Ireland






Diclofenac sodium


Diclac 25 mg/ml Solution for Injection 3 ml Ampoule


25 mg


Solution for injection


Intramuscular use




Ireland







Pfizer Healthcare Ireland




9 Riverwalk




National Digital Park




Citywest Business Campus




Dublin 24




Ireland






Diclofenac sodium


Arthrotec 50 modified release tablets


50 mg


Modified-release tablet


Oral use




Ireland







Pfizer Healthcare Ireland




9 Riverwalk




National Digital Park




Citywest Business Campus




Dublin 24




Ireland






Diclofenac sodium


Arthrotec 75 modified-release tablets


75 mg


Modified-release tablet


Oral use




Ireland







Astellas Pharma Co. Ltd




5 Waterside




Citywest Busniess Campus Naas Road




Dublin 24




Ireland






Diclofenac sodium


Difene 25 mg Capsules


25 mg


Capsule


Oral use




Ireland







Astellas Pharma Co. Ltd




5 Waterside




Citywest Busniess Campus Naas Road




Dublin 24




Ireland






Diclofenac sodium


Difene 50 mg Capsules


50 mg


Capsule


Oral use




Ireland







Astellas Pharma Co. Ltd




5 Waterside




Citywest Busniess Campus Naas Road




Dublin 24




Ireland






Diclofenac sodium


Difene 75 mg Dual Release Capsules


75 mg


Dual release capsule


Oral use




Ireland







Astellas Pharma Co. Ltd




5 Waterside




Citywest Busniess Campus Naas Road




Dublin 24




Ireland






Diclofenac sodium


Difene 100 mg Dual Release Capsules


100 mg


Dual release capsule


Oral use




Ireland







Astellas Pharma Co. Ltd




5 Waterside




Citywest Busniess Campus Naas Road




Dublin 24




Ireland






Diclofenac sodium


Difene ampoules 75 mg/3 ml Solution for Injection or Concentrate for Solution for Infusion


75 mg/3 ml


Solution for injection or concentrate for solution for infusion


Intramuscular use, Intravenous use




Ireland







Astellas Pharma Co. Ltd




5 Waterside




Citywest Busniess Campus Naas Road




Dublin 24




Ireland






Diclofenac sodium


Difene 100 mg Suppositories


100 mg


Suppository


Rectal use




Ireland







Actavis Group PTC ehf




Reykjavikurvegi 76-78




IS-220 Hafnarfjördur




Iceæand






Diclofenac potassium


Kyflam 50 mg Film Coated Tablet


50 mg


Film-coated tablet


Oral use




Ireland







Morningside Healthcare Limited




115 Narborough Road




Leicester, LE3 0PA




United Kingdom






Diclofenac Sodium
Misoprostol


Diclofenac 50 mg/Misoprostol 200 micrograms modified release tablets


50 mg
0,2 mg


Modified Release Tablet


Oral use




Ireland







Morningside Healthcare Limited




115 Narborough Road




Leicester, LE3 0PA




United Kingdom






Diclofenac Sodium
Misoprostol


Diclofenac 75 mg/Misoprostol 200 micrograms modified release tablets


75 mg
0,2 mg


Modified Release Tablet


Oral use




Italy







Novartis Farma S.p.A.




Largo Umberto Boccioni, 1




Origgio - 21040 Varese




Italy






Diclofenac


VOLTAREN


50 mg


Soluble tablet


Oral use




Italy







Novartis Farma S.p.A.




Largo Umberto Boccioni, 1




Origgio - 21040 Varese




Italy






Diclofenac


VOLTAREN


50 mg


Gastro-resistant tablet


Oral use




Italy







Novartis Farma S.p.A.




Largo Umberto Boccioni, 1




Origgio - 21040 Varese




Italy






Diclofenac


VOLTAREN


75 mg


Prolonged-release tablet


Oral use




Italy







Novartis Farma S.p.A.




Largo Umberto Boccioni, 1




Origgio - 21040 Varese




Italy






Diclofenac


VOLTAREN


100 mg


Prolonged-release tablet


Oral use




Italy







Novartis Farma S.p.A.




Largo Umberto Boccioni, 1




Origgio - 21040 Varese




Italy






Diclofenac


VOLTAREN


100 mg


Suppository


Rectal use




Italy







Novartis Farma S.p.A.




Largo Umberto Boccioni, 1




Origgio - 21040 Varese




Italy






Diclofenac


VOLTAREN


75 mg/3 ml


Solution for injection


Intramuscular use




Italy







Industria Farmaceutica Galenica Senese S.r.l.




Via Cassia Nord




351 Darvia - 53014 Siena




Italy






Diclofenac sodico


ALGOSENAC


75 mg/3 ml


Solution for injection


Intramuscular use




Italy







Bayer S.p.a.




Viale Certosa, 130




Milano - 20156




Italy






Diclofenac hydroxyethylpyrrolidine


BAIFENAC


50 mg


Granules


Oral use




Italy







CostanzaFarma srl




Via Taranto 4




20142 Milano




Italy






Diclofenac sodico


DEALGIC


75 mg


Prolonged-release capsule, hard


Oral use




Italy







CostanzaFarma srl




Via Taranto 4




20142 Milano




Italy






Diclofenac sodico


DEALGIC


100 mg


Prolonged-release capsule, hard


Oral use




Italy







DAICHI SANKYO Italia S.p.a.




Via Paolo Di Dono 73




00142, Rome




Italy






Diclofenac sodico


DEFLAMAT


25 mg/ml


Solution for injection


Intramuscular use




Italy







DAICHI SANKYO Italia S.p.a.




Via Paolo Di Dono 73




00142, Rome




Italy






Diclofenac sodico


DEFLAMAT


75 mg


Prolonged-release capsule, hard


Oral use




Italy







DAICHI SANKYO Italia S.p.a.




Via Paolo Di Dono 73




00142, Rome




Italy






Diclofenac sodico


DEFLAMAT


100 mg


Prolonged-release capsule, hard


Oral use




Italy







Crinos S.p.a.




Via Pavia, 6




Milano - 20136




Italy






Diclofenac sodico


DICLOFAN


100 mg


Prolonged-release tablet


Oral use




Italy







Crinos S.p.a.




Via Pavia, 6




Milano - 20136




Italy






Diclofenac sodico


DICLOFAN


75 mg/3 ml


Solution for injection


Intramuscular use




Italy







Sandoz S.p.a.




Largo Umberto Boccioni, 1




Origgio, Varese - 21040




Italy






Diclofenac sodico


DICLOFENAC


75 mg/3 ml


Solution for injection


Intramuscular use




Italy







Sandoz S.p.a.




Largo Umberto Boccioni, 1




Origgio, Varese - 21040




Italy






Diclofenac sodico


DICLOFENAC


100 mg


Suppository


Rectal use




Italy







Alpha Biotech S.r.l.




Via Ragazzi del 99




5, Bologna - 40133




Italy






Diclofenac sodico


DICLOFENAC ALPHA BIOTECH


50 mg


Suppository


Rectal use




Italy







Alpha Biotech S.r.l.




Via Ragazzi del 99




5, Bologna - 40133




Italy






Diclofenac sodico


DICLOFENAC ALPHA BIOTECH


100 mg


Suppository


Rectal use




Italy







Alpha Biotech S.r.l.




Via Ragazzi del 99




5, Bologna - 40133




Italy






Diclofenac sodico


DICLOFENAC ALPHA BIOTECH


25 mg


Tablet


Oral use




Italy







Alpha Biotech S.r.l.




Via Ragazzi del 99




5, Bologna - 40133




Italy






Diclofenac sodico


DICLOFENAC ALPHA BIOTECH


75 mg/3 ml


Solution for injection


Intramuscular use




Italy







Alpha Biotech S.r.l.




Via Ragazzi del 99




5, Bologna - 40133




Italy






Diclofenac sodico


DICLOFENAC ALPHA BIOTECH


50 mg


Tablet


Oral use




Italy







Alpha Biotech S.r.l.




Via Ragazzi del 99




5, Bologna - 40133




Italy






Diclofenac sodico


DICLOFENAC ALPHA BIOTECH


100 mg


Prolonged-release tablet


Oral use




Italy







Alpha Biotech S.r.l.




Via Ragazzi del 99




5, Bologna - 40133




Italy






Diclofenac sodico


DICLOFENAC ALPHA BIOTECH


150 mg


Prolonged-release capsule


Oral use




Italy







Alpha Biotech S.r.l.




Via Ragazzi del 99




5, Bologna - 40133




Italy






Diclofenac sodico


DICLOFENAC ALPHA BIOTECH


25 mg/ml


Oral drops, solution


Oral use




Italy







Almus S.r.l.




Via Cesarea, 11/10




Genova - 16121




Italy






Diclofenac sodico


DICLOFENAC ALMUS


75 mg/3 ml


Solution for injection


Intramuscular use




Italy







Angenerico S.p.a.




Via Nocera Umbra 75




Roma - 00181




Italy






Diclofenac sodico


DICLOFENAC ANGENERICO


75 mg/3 ml


Solution for injection


Intramuscular use




Italy







Angenerico S.p.a.




Via Nocera Umbra 75




Roma - 00181




Italy






Diclofenac sodico


DICLOFENAC ANGENERICO


100 mg


Suppository


Rectal use




Italy







Angenerico S.p.a.




Via Nocera Umbra 75




Roma - 00181




Italy






Diclofenac sodico


DICLOFENAC ANGENERICO


50 mg


Gastro-resistant tablet


Oral use




Italy







Angenerico S.p.a.




Via Nocera Umbra 75




Roma - 00181




Italy






Diclofenac sodico


DICLOFENAC ANGENERICO


25 mg


Gastro-resistant tablet


Oral use




Italy







Doc Generici S.r.l.




Via Manuzio 7




Milano - 20124




Italy






Diclofenac sodico


DICLOFENAC DOC


75 mg/3 ml


Solution for injection


Intramuscular use




Italy







Doc Generici S.r.l.




Via Manuzio 7




Milano - 20124




Italy






Diclofenac sodico


DICLOFENAC DOC GENERICI


75 mg


Prolonged-release tablet


Oral use




Italy







Doc Generici S.r.l.




Via Manuzio 7




Milano - 20124




Italy






Diclofenac sodico


DICLOFENAC DOC GENERICI


100 mg


Prolonged-release tablet


Oral use




Italy







EG S.p.a




Via Scarlatti, 31




Milano - 20124




Italy






Diclofenac sodico


DICLOFENAC EG


75 mg/3 ml


Solution for injection


Intramuscular use




Italy







EG S.p.a




Via Scarlatti, 31




Milano - 20124




Italy






Diclofenac sodico


DICLOFENAC EG


50 mg


Gastro-resistant tablet


Oral use




Italy







EG S.p.a




Via Scarlatti, 31




Milano - 20124




Italy






Diclofenac sodico


DICLOFENAC EG


100 mg


Prolonged-release tablet


Oral use




Italy







EG S.p.a




Via Scarlatti, 31




Milano - 20124




Italy






Diclofenac sodico


DICLOFENAC EG


100 mg


Suppository


Rectal use




Italy







Germed Pharma S.p.a.




Via Cantu, 11, Balsamo




Milano, 20092




Italy






Diclofenac sodico


DICLOFENAC GERMED


75 mg/3 ml


Solution for injection


Intramuscular use




Italy







HEXAL S.p.a.




Centro Direzionale Colleoni




Palazzo Andromeda




Via Paracelso, 16




Brianza, Milano, 20041




Italy






Diclofenac sodico


DICLOFENAC HEXAL


75 mg/3 ml


Solution for injection


Intramuscular use




Italy







HEXAL S.p.a.




Centro Direzionale Colleoni




Palazzo Andromeda




Via Paracelso, 16




Brianza, Milano, 20041




Italy






Diclofenac sodico


DICLOFENAC HEXAL


100 mg


Suppository


Rectal use




Italy







HEXAL S.p.a.




Centro Direzionale Colleoni




Palazzo Andromeda




Via Paracelso, 16




Brianza, Milano, 20041




Italy






Diclofenac sodico


DICLOFENAC HEXAL


50 mg


Gastro-resistant tablet


Oral use




Italy







HEXAL S.p.a.




Centro Direzionale Colleoni




Palazzo Andromeda




Via Paracelso, 16




Brianza, Milano, 20041




Italy






Diclofenac sodico


DICLOFENAC HEXAL


25 mg


Gastro-resistant tablet


Oral use




Italy







Mylan S.p.a.




Via Vittor Pisani, 20




Milano - 20124




Italy






Diclofenac sodico


DICLOFENAC MYLAN GENERICS


100 mg


Prolonged-release tablet


Oral use




Italy







Mylan S.p.a.




Via Vittor Pisani, 20




Milano - 20124




Italy






Diclofenac sodico


DICLOFENAC MYLAN GENERICS


100 mg


Suppository


rectal use




Italy







Sandoz S.p.a.




Largo Umberto Boccioni, 1




Origgio, Varese - 21040




Italy






Diclofenac sodico


DICLOFENAC SODICO


100 mg


Prolonged-release tablet


Oral use




Italy







Biologici Italia Laboratories S.r.l.




Via Serpero, 2




Masate, Milano - 20060




Italy






Diclofenac sodico


DICLOFENAC SODICO BIL


75 mg/3 ml


Solution for injection


Intramuscular use




Italy







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenac sodico


DICLOREUM


50 mg


Suppository


rectal use




Italy







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenac sodico


DICLOREUM


100 mg


Suppository


rectal use




Italy







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenac sodico


DICLOREUM


75 mg/3 ml


Solution for injection


Intramuscular use




Italy







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenac sodico


DICLOREUM


100 mg


Prolonged-release tablet


Oral use




Italy







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenac sodico


DICLOREUM


150 mg


Prolonged-release capsule, hard


Oral use




Italy







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenac sodico


DICLOREUM


50 mg


Granules


Oral use




Italy







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenac sodico


DICLOREUM


50 mg


Gastro-resistant tablet


Oral use




Italy







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenac sodico


DICLOREUM


25 mg/ml


Oral drops, solution


Oral use




Italy







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenac sodico


DICLOREUM


46,5 mg/ml


Oral drops, solution


Oral use




Italy







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenac hydroxyethylpyrrolidine


DIEP


25 mg


Gastro-resistant tablet


Oral use




Italy







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenac hydroxyethylpyrrolidine


DIEP


25 mg


Granules for oral suspension


Oral use




Italy







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenac potassico


EMINOCS


50 mg


Oral drops, solution


Oral use




Italy







Proge Farm S.r.l.




Largo Donegani 4/a




Novara - 28100




Italy






Diclofenac sodico


FENADOL


100 mg


Prolonged-release tablet


Oral use




Italy







Wellington Street Development Pharma Limited




47 Oaklands Drive Rathgar




Dublin 6




Ireland






Diclofenac sodico


FENDER


75 mg/3 ml


Solution for injection


Intramuscular use




Italy







Wellington Street Development Pharma Limited




47 Oaklands Drive Rathgar




Dublin 6




Ireland






Diclofenac sodico


FENDER


100 mg


Prolonged-release tablet


Oral use




Italy







Bayer S.p.a.




Viale Certosa, 130




Milano - 20156




Italy






Diclofenac hydroxyethylpyrrolidine


FLECTOR DOLORE


25 mg


Granules for oral solution


Oral use




Italy







Menarini Industrie Farmaceutiche Riunite S.r.l.




Via Sette Santi 3,




Firenze 50131- Italy






Diclofenac sodico


FLOGOFENAC


100 mg


Prolonged-release capsule, hard


Oral use




Italy







FIDIA Farmaceutici S.p.a.




Via Ponte della Fabbrica




3/a, Abano Terme




Padova - 35031




Italy






Diclofenac potassico


ITAMIFAST


25 mg


Film-coated tablet


Oral use




Italy







FIDIA Farmaceutici S.p.a.




Via Ponte della Fabbrica




3/a, Abano Terme




Padova - 35031




Italy






Diclofenac potassico


ITAMIFAST


50 mg


Film-coated tablet


Oral use




Italy







Scandinavian Regulatory Services, AB




Svardvagen 3B




Stockholm SE-182 33




Sweden






Diclofenac potassico


KAPPADI


25 mg


Film-coated tablet


Oral use




Italy







Scandinavian Regulatory Services, AB




Svardvagen 3B




Stockholm SE-182 33




Sweden






Diclofenac potassico


KAPPADI


50 mg


Film-coated tablet


Oral use




Italy







Novartis Pharma S.p.A.




Largo Umberto Boccioni, 1




Origgio - 21040 Varese




Italy






Diclofenac sodico


NOVAPIRINA


25 mg


Coated tablet


Oral use




Italy







O. P. PHARMA S.r.l.




Via Torino 51




Milano - 20123




Italy






Diclofenac sodico


TRAULEN


100 mg


Film-coated tablet


Oral use




Italy







O. P. PHARMA S.r.l.




Via Torino 51




Milano - 20123




Italy






Diclofenac sodico


TRAULEN


75 mg/3 ml


Solution for injection


Intramuscular use




Italy







Novartis Pharma S.p.A.




Largo Umberto Boccioni, 1




Origgio - 21040 Varese




Italy






Diclofenac sodico


VOLTADVANCE


25 mg


Powder for oral solution


Oral use




Italy







Novartis Pharma S.p.A.




Largo Umberto Boccioni, 1




Origgio - 21040 Varese




Italy






Diclofenac sodico


VOLTADVANCE


25 mg


Film-coated tablet


Oral use




Italy







Novartis Pharma S.p.A.




Largo Umberto Boccioni, 1




Origgio - 21040 Varese




Italy






Diclofenac potassico


VOLTFAST


50 mg


Coated tablet


Oral use




Italy







Novartis Pharma S.p.A.




Largo Umberto Boccioni, 1




Origgio - 21040 Varese




Italy






Diclofenac potassico


VOLTFAST


25 mg


Coated tablet


Oral use




Italy







Novartis Pharma S.p.A.




Largo Umberto Boccioni, 1




Origgio - 21040 Varese




Italy






Diclofenac potassico


VOLTFAST


50 mg


Granules for oral solution


Oral use




Italy







Altergon Italia S.r.l.




Via Dell'Industria




Pietradefusi - 83030 Avellino




Italy






Diclofenac


INFORCE


75 mg/ml


Solution for injection


Intramuscular use, Subcutaneous use




Italy







Altergon Italia S.r.l.




Via Dell'Industria




Pietradefusi - 83030 Avellino




Italy






Diclofenac sodico


INDICAM


75 mg/ml


Solution for injection


Intramuscular use, Subcutaneous use




Italy







Pfizer Italia S.r.l.




Via Isonzo 71




Latina 04100




Italy






Diclofenac sodico
Misoprostolo


MISOFENAC


50 mg
0,2 mg


Tablet


Oral use




Italy







Pfizer Italia S.r.l.




Via Isonzo 71




Latina 04100




Italy






Diclofenac sodico
Misoprostolo


MISOFENAC


75 mg
0,2 mg


Modified-release tablet


Oral use




Italy







Pfizer Italia S.r.l.




Via Isonzo 71




Latina 04100




Italy






Diclofenac sodico
Misoprostolo


ARTROTEC


50 mg
0,2 mg


Tablet


Oral use




Italy







Pfizer Italia S.r.l.




Via Isonzo 71




Latina 04100




Italy






Diclofenac sodico
Misoprostolo


ARTROTEC


75 mg
0,2 mg


Modified-release tablet


Oral use




Italy







HEXAL AG S.p.a.




Industriestrasse, 25, D-83607




HOLZKIRCHEN




Germany






Diclofenac sodico


DICLOFENAC HEXAL AG


100 mg


Prolonged-release tablet


oral use




Italy







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac sodico


DICLOFENAC RATIOPHARM


50 mg


Gastro-resistant tablet


oral use




Italy







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac sodico


DICLOFENAC RATIOPHARM


75 mg/3 ml


solution for injection


Intramuscular use




Latvia







Cipla (UK) Ltd




The Old Post House




Heath Road, Weybridge




Surrey KT138TS




United Kingdom






Diclofenacum natricum


Profenac 75 mg/3 ml solution for injection


75 mg/3 ml


Solution for injection


Intramuscular use




Latvia







Cipla (UK) Ltd




The Old Post House




Heath Road, Weybridge




Surrey KT138TS




United Kingdom






Diclofenacum natricum


Profenac SR 100 mg prolonged-release tablets


100 mg


Prolonged-release tablet


Oral use




Latvia







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenacum natricum


Diclofenac-ratiopharm 50 mg gastro-resistant tablets


50 mg


Gastro-resistant tablet


Oral use




Latvia







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenacum natricum


Diclofenac-ratiopharm 25 mg gastro-resistant tablets


25 mg


Gastro-resistant tablet


Oral use




Latvia







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenacum natricum


Diclofenac-ratiopharm uno 150 mg prolonged-release tablets


150 mg


Prolonged-release tablet


Oral use




Latvia







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenacum natricum


Diclofenac-ratiopharm 75 mg/2 ml solution for injection


75 mg/2 ml


Solution for injection


Intramuscular use




Latvia







Cipla (UK) Ltd




The Old Post House




Heath Road, Weybridge




Surrey KT138TS




United Kingdom






Diclofenacum natricum


Diclogen 50 mg suppositories


50 mg


Suppository


Rectal use




Latvia







Cipla (UK) Ltd




The Old Post House




Heath Road, Weybridge




Surrey KT138TS




United Kingdom






Diclofenacum natricum


Diclogen 100 mg suppositories


100 mg


Suppository


Rectal use




Latvia







Sandoz d.d.




Verovskova 57




SI-1000 Ljubljana




Slovenia






Diclofenacum natricum


Diclac 75 mg/3 ml solution for injection/infusion


75 mg/3 ml


Solution for injection and infusion


Intramuscular use, Intravenous use




Latvia







Sandoz d.d.




Verovskova 57




SI-1000 Ljubljana




Slovenia






Diclofenacum natricum


Diclac 100 mg modified release tablets


100 mg


Modified-release tablet


Oral use




Latvia







Sandoz d.d.




Verovskova 57




SI-1000 Ljubljana




Slovenia






Diclofenacum natricum


Diclac ID 75 mg modified release tablets


75 mg


Modified-release tablet


Oral use




Latvia







Sandoz d.d.




Verovskova 57




SI-1000 Ljubljana




Slovenia






Diclofenacum natricum


Diclac ID 150 mg modified release tablets


150 mg


Modified-release tablet


Oral use




Latvia







G.L. Pharma GmbH




Schlossplatz 1




A-8502 Lannach




Austria






Diclofenacum natricum


Diclomelan retard 100 mg sustained-release tablets


100 mg


Prolonged-release tablet


Oral use




Latvia







G.L. Pharma GmbH




Schlossplatz 1




A-8502 Lannach




Austria






Diclofenacum natricum


Diclomelan 50 mg gastro-resistant tablets


50 mg


Gastro-resistant tablet


Oral use




Latvia







G.L. Pharma GmbH




Schlossplatz 1




A-8502 Lannach




Austria






Diclofenacum natricum


Diclomelan 100 mg suppositories


100 mg


Suppository


Rectal use




Latvia







G.L. Pharma GmbH




Schlossplatz 1




A-8502 Lannach




Austria






Diclofenacum natricum
Thiamini hydrochloridum
Pyridoxini hydrochloridum
Cyanocobalaminum


Diclovit hard capsules


50 mg
50 mg
50 mg
0,25 mg


Capsule, hard


Oral use




Latvia







SIA Briz




Rasas iela 5




Riga, LV-1057




Latvia






Diclofenacum natricum


Feloran 75 mg/3 ml solution for injection


75 mg/3 ml


Solution for injection


Intramuscular use, Intravenous use




Latvia







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenacum natricum
Lidocainum hydrochloridum


Olfen 75 mg/20 mg/2 ml solution for injection


75 mg/2 ml
20 mg/2 ml


Solution for injection


Intramuscular use




Latvia







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenacum natricum


Olfen Lactab 50 mg gastro-resistant tablets


50 mg


Gastro-resistant tablet


Oral use




Latvia







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenacum natricum


Olfen Depocaps 100 mg prolonged-release capsules, hard


100 mg


Prolonged-release capsule, hard


Oral use




Latvia







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenacum natricum


Olfen Rectocaps 100 mg rectal capsules


100 mg


Rectal capsule


Rectal use




Latvia







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenacum natricum


Olfen Depotabs 75 mg prolonged release tablets


75 mg


Prolonged-release tablet


Oral use




Latvia







Vitabalans OY




Varastokatu 8




FI-135 000 Hämeenlinna




Finland






Diclofenac potassium


Dicuno 25 mg film-coated tablets


25 mg


Film-coated tablet


Oral use




Latvia







Vitabalans OY




Varastokatu 8




FI-135 000 Hämeenlinna




Finland






Diclofenac potassium


Dicuno 50 mg film-coated tablets


50 mg


Film-coated tablet


Oral use




Latvia







Berlin-Chemie AG




(Menarini Group)




Glienicker Weg 125




12489 Berlin




Germany






Diclofenacum natricum


Dicloberl 75 mg/3 ml solution for injection


75 mg/3 ml


Solution for injection


Intramuscular use




Latvia







Berlin-Chemie AG




(Menarini Group)




Glienicker Weg 125




12489 Berlin




Germany






Diclofenacum natricum


Dicloberl 100 mg suppositories


100 mg


Suppository


rectal use




Latvia







Berlin-Chemie AG




(Menarini Group)




Glienicker Weg 125




12489 Berlin




Germany






Diclofenacum natricum


Dicloberl 50 mg gastro-resistant tablets


50 mg


Gastro-resistant tablet


Oral use




Latvia







Berlin-Chemie AG




(Menarini Group)




Glienicker Weg 125




12489 Berlin




Germany






Diclofenacum natricum


Dicloberl retard 100 mg prolonged release capsules


100 mg


Prolonged-release capsule


Oral use




Latvia







Pharmaceutical Works POLPHARMA SA




ul. Pelplińska 19




83-200 Starogard Gdański




Poland






Diclofenacum natricum


Majamil retard 100 mg prolonged-release tablets


100 mg


Prolonged-release tablet


Oral use




Latvia







A/S “Olainfarm”




Rupnicu iela 5




Olaine, LV – 2114




Latvia






Diclofenac potassium


Dikloferol 50 mg coated tablets


50 mg


Coated tablet


Oral use




Latvia







SIA PharmaSwiss Latvia




Gertrudes iela 54 – 5




Riga, LV 1011




Latvia






Diclofenacum natricum


Diclorapid 75 mg gastro-resistant capsules, hard


75 mg


Gastro-resistant capsule, hard


Oral use




Latvia







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Diclofenacum natricum


Voltaren 75 mg/3 ml solution for injection


75 mg/3 ml


Solution for injection


Intramuscular use, Intravenous use




Latvia







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Diclofenac potassium


Voltaren Akti 12,5 mg film-coated tablets


12,5 mg


Film-coated tablet


Oral use




Latvia







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Diclofenac potassium


Voltaren Akti 25 mg soft capsules


25 mg


Capsule, soft


Oral use




Latvia







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Diclofenacum natricum


Voltaren Retard 100 mg modified-release film-coated tablets


100 mg


Modified-release tablet


Oral use




Latvia







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Diclofenac potassium


Cataflam 50 mg film-coated tablets


50 mg


Film-coated tablet


Oral use




Latvia







GlaxoSmithKline Latvia SIA




Duntes iela 11




Riga LV - 1013




Latvia






Diclofenacum natricum


Diclofenac 50 mg suppositories


50 mg


Suppository


Rectal use




Latvia







GlaxoSmithKline Latvia SIA




Duntes iela 11




Riga LV - 1013




Latvia






Diclofenacum natricum


Diclofenac 100 mg suppositories


100 mg


Suppository


Rectal use




Latvia







Krka, d.d.




Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






Diclofenacum natricum


Naklofen SR 100 mg prolonged-release tablets


100 mg


Prolonged-release tablet


Oral use




Latvia







Krka, d.d.




Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






Diclofenacum natricum


Naklofen 75 mg/3 ml solution for injection


75 mg/3 ml


Solution for injection


Intramuscular use




Latvia







Krka, d.d.




Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






Diclofenacum natricum


Naklofen 50 mg gastro-resistant tablets


50 mg


Gastro-resistant tablet


Oral use




Latvia







Medochemie Ltd




1-10 Constantinoupoleos str




P.O. Box 51409




Limassol 3505




Cyprus






Diclofenacum natricum


Almiral 25 mg/ml solution for injection and infusion


25 mg/ml


Solution for injection and infusion


Intramuscular use, Intravenous use




Latvia







CT Arzneimittel GmbH




Graf-Arco-Strasse 3




89079 Ulm




Germany






Diclofenacum natricum


Diclo CT 75 mg/2 ml solution for injection


75 mg/2 ml


Solution for injection


Intramuscular use




Lithuania







Sandoz d.d.




Verovskova 57




SI-1000 Ljubljana




Slovenia






Diclofenac


Diclac


75 mg/3 ml


Solution for injection/infusion


Intramuscular use, Intravenous use




Lithuania







Sandoz d.d.




Verovskova 57




SI-1000 Ljubljana




Slovenia






Diclofenac


Diclac


100 mg


Prolonged-release tablet


Oral use




Lithuania







Sandoz d.d.




Verovskova 57




SI-1000 Ljubljana




Slovenia






Diclofenac


Diclac ID


75 mg


Modified-release tablet


Oral use




Lithuania







Sandoz d.d.




Verovskova 57




SI-1000 Ljubljana




Slovenia






Diclofenac


Diclac ID


150 mg


Modified-release tablet


Oral use




Lithuania







UAB „PharmaSwiss“




Šeimyniškių g. 21B




LT-09200, Vilnius




Lithuania






Diclofenac


DicloRapid


75 mg


Gastro-resistant capsule, hard


Oral use




Lithuania







Berlin-Chemie AG




(Menarini Group)




Glienicker Weg 125




12489 Berlin




Germany






Diclofenac


Dicloberl


75 mg/3 ml


Solution for injection


Intramuscular use




Lithuania







Berlin-Chemie AG




(Menarini Group)




Glienicker Weg 125




12489 Berlin




Germany






Diclofenac


Dicloberl


50 mg


Gastro-resistant tablet


Oral use




Lithuania







Berlin-Chemie AG




(Menarini Group)




Glienicker Weg 125




12489 Berlin




Germany






Diclofenac


Dicloberl


100 mg


Suppository


Rectal use




Lithuania







UAB „BERLIN CHEMIE MENARINI BALTIC“




Jasinskio g. 16 a,




01112 Vilnius




Lithuania






Diclofenac


Dicloberl retard


100 mg


Prolonged-release capsule, hard


Oral use




Lithuania







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac


Diclofenac-ratiopharm


50 mg


Gastro-resistant tablet


Oral use




Lithuania







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac


Diclofenac-ratiopharm


100 mg


Suppository


Rectal use




Lithuania







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac


Diclofenac-ratiopharm


50 mg


Suppository


Rectal use




Lithuania







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac


Diclofenac-ratiopharm


75 mg/2 ml


Solution for injection


Intramuscular use




Lithuania







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac


Diclofenac-ratiopharm


100 mg


Prolonged-release capsule, hard


Oral use




Lithuania







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac


Diclofenac-ratiopharm uno


150 mg


Modified-release tablet


Oral use




Lithuania







G.L. Pharma GmbH




Schlossplatz 1




A-8502 Lannach




Austria






Diclofenac


Diclomelan


100 mg


Suppository


Rectal use




Lithuania







G.L. Pharma GmbH




Schlossplatz 1




A-8502 Lannach




Austria






Diclofenac


Diclomelan


50 mg


Gastro-resistant tablet


Oral use




Lithuania







G.L. Pharma GmbH




Schlossplatz 1




A-8502 Lannach




Austria






Diclofenac


Diclomelan retard


100 mg


Prolonged-release tablet


Oral use




Lithuania







UAB Corpus Medica




Sukilėlių pr. 61




LT-49333 Kaunas




Lithuania






Diclofenac


FELORAN


75 mg/3 ml


Solution for injection


Intramuscular use




Lithuania







Actavis Nordic A/S




Ørnegårdsvej 16




DK-2820 Gentofte




Denmark






Diclofenac


Feloran


100 mg


Prolonged-release tablet


Oral use




Lithuania







Krka, d.d.




Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






Diclofenac


Naklofen


75 mg/3 ml


Solution for injection


Intramuscular use




Lithuania







Krka, d.d.




Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






Diclofenac


Naklofen


50 mg


Gastro-resistant tablet


Oral use




Lithuania







Krka, d.d.




Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






Diclofenac


Naklofen


50 mg


Suppository


Rectal use




Lithuania







Krka, d.d.




Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






Diclofenac


Naklofen SR


100 mg


Prolonged-release tablet


Oral use




Lithuania







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenac


Olfen Depocaps


100 mg


Prolonged-release capsule, hard


Oral use




Lithuania







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenac


Olfen Depotabs


75 mg


Prolonged-release tablet


Oral use




Lithuania







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenac


Olfen Lactab


50 mg


Gastro-resistant coated tablet


Oral use




Lithuania







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenac


Olfen Rectocaps


100 mg


Rectal capsule


Rectal use




Lithuania







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Diclofenac


Voltaren


75 mg/3 ml


Solution for injection/infusion


Intramuscular use, Intravenous use




Lithuania







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Diclofenac


Voltaren


100 mg


Suppository


Rectal use




Lithuania







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Diclofenac


Voltaren Akti


25 mg


Coated tablet


Oral use




Lithuania







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Diclofenac


Voltaren Akti


12,5 mg


Film-coated tablet


Oral use




Lithuania







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Diclofenac


Voltaren Retard


100 mg


Prolonged-release tablet


Oral use




Lithuania







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Diclofenac


Voltaren Akti


25 mg


Capsule, soft


Oral use




Lithuania







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Diclofenac


Cataflam


50 mg


Coated tablet


Oral use




Lithuania







Vitabalans OY




Varastokatu 8




FI-135 000 Hämeenlinna




Finland






Diclofenac


Dicuno


25 mg


Film-coated tablet


Oral use




Lithuania







Vitabalans OY




Varastokatu 8




FI-135 000 Hämeenlinna




Finland






Diclofenac


Dicuno


50 mg


Film-coated tablet


Oral use




Lithuania







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenac
Lidocaine


Olfen


75 mg/2 ml
20 mg/2 ml


Solution for injection


Intramuscular use




Lithuania







G.L. Pharma GmbH




Schlossplatz 1




A-8502 Lannach




Austria






Diclofenac
Thiamine
Pyridoxine
Cyanocobalamin


Diclovit


50 mg
50 mg
50 mg
0,25 mg


Capsule, hard


Oral use




Luxembourg







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenac potassium


Cataflam


50 mg


Coated tablet


Oral use




Luxembourg







Hexal AG




Industriestraße 25




D-83607 Holzkirchen




Germany






Diclofenac sodium


Diclac retard 100


100 mg


Prolonged-release tablet


Oral use




Luxembourg







Hexal AG




Industriestraße 25




D-83607 Holzkirchen




Germany






Diclofenac sodium


Diclac 75 mg/3 ml Injektionslösung


75 mg


solution for injection


Intramuscular use




Luxembourg







Hexal AG




Industriestraße 25




D-83607 Holzkirchen




Germany






Diclofenac sodium


Diclac-100 Zäpfchen


100 mg


suppository


Rectal use




Luxembourg







Hexal AG




Industriestraße 25




D-83607 Holzkirchen




Germany






Diclofenac sodium


Diclac-25


25 mg


Gastro-resistant coated tablet


Oral use




Luxembourg







Hexal AG




Industriestraße 25




D-83607 Holzkirchen




Germany






Diclofenac sodium


Diclac-50


50 mg


Gastro-resistant coated tablet


Oral use




Luxembourg







Hexal AG




Industriestraße 25




D-83607 Holzkirchen




Germany






Diclofenac sodium


Diclac-50 Zäpfchen


50 mg


suppository


Rectal use




Luxembourg







N.V. Eurogenerics S.A




Esplanade Heysel b 22




B-1020 Bruxelles




Belgium






Diclofenac sodium


Diclofenac EG-25


25 mg


Coated tablet


Oral use




Luxembourg







N.V. Eurogenerics S.A




Esplanade Heysel b 22




B-1020 Bruxelles




Belgium






Diclofenac sodium


Diclofenac EG-50


50 mg


Coated tablet


Oral use




Luxembourg







N.V. Eurogenerics S.A




Esplanade Heysel b 22




B-1020 Bruxelles




Belgium






Diclofenac sodium


Diclofenac EG retard 75


75 mg


Prolonged-release tablet


Oral use




Luxembourg







N.V. Eurogenerics S.A




Esplanade Heysel b 22




B-1020 Bruxelles




Belgium






Diclofenac sodium


Diclofenac EG retard 100


100 mg


Prolonged-release tablet


Oral use




Luxembourg







N.V. Eurogenerics S.A




Esplanade Heysel b 22




B-1020 Bruxelles




Belgium






Diclofenac sodium


Diclofenac EG 75 mg/3 ml solution injectable


75 mg


solution for injection


Intramuscular use, Intravenous use




Luxembourg







N.V. Eurogenerics S.A




Esplanade Heysel b 22




B-1020 Bruxelles




Belgium






Diclofenac sodium


Diclofenac EG 100 suppositoire


100 mg


suppository


Rectal use




Luxembourg







Mylan bvba




Rozendal Businesspark




Terhulpsesteenweg 6A




B-1560 Hoeilaart




Belgium






Diclofenac sodium


Diclofenac Mylan-75 Retard


75 mg


Prolonged-release tablet


Oral use




Luxembourg







Mylan bvba




Rozendal Businesspark




Terhulpsesteenweg 6A




B-1560 Hoeilaart




Belgium






Diclofenac sodium


Diclofenac Mylan-100 Retard


100 mg


Prolonged-release tablet


Oral use




Luxembourg







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac sodium


Diclofenac Ratiopharm-100 Zäpfchen


100 mg


suppository


Rectal use




Luxembourg







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac sodium


Diclofenac Ratiopharm-25


25 mg


Gastro-resistant coated tablet


Oral use




Luxembourg







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac sodium


Diclofenac Ratiopharm-50


50 mg


Gastro-resistant coated tablet


Oral use




Luxembourg







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac sodium


Diclofenac Ratiopharm 75 mg/2 ml Injektionslösung


75 mg


solution for injection


Intramuscular use




Luxembourg







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac sodium


Diclofenac Retard Ratiopharm-100


100 mg


Prolonged-release capsule, hard


Oral use




Luxembourg







Daiichi Sankyo Belgium SA




Rue Fond Jean Pâques 5




B-1348 Louvain-la-Neuve




Belgium






Diclofenac sodium


Motifene-75


75 mg


Modified- release capsule, hard


Oral use




Luxembourg







Socobom S.A




Avenue Louise 149 b24




B-1050 Bruxelles




Belgium






Diclofenac sodium


Polyflam-50


50 mg


Gastro-resistant coated tablet


Oral use




Luxembourg







Socobom S.A




Avenue Louise 149 b24




B-1050 Bruxelles




Belgium






Diclofenac sodium


Polyflam-75


75 mg


Prolonged-release tablet


Oral use




Luxembourg







Continental Pharma




Rijksweg, 12




B-2870 Puurs




Belgium






Diclofenac sodium
Misoprostol


Arthrotec-50


50 mg
0,2 mg


Modified-release capsule, hard


Oral use




Luxembourg







Continental Pharma




Rijksweg, 12




B-2870 Puurs




Belgium






Diclofenac sodium
Misoprostol


Arthrotec-75


75 mg
0,2 mg


Modified-release capsule, hard


Oral use




Luxembourg







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenac sodium


Voltaren-100 Zäpfchen


100 mg


suppository


Rectal use




Luxembourg







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenac sodium


Voltaren-25


25 mg


Gastro-resistant coated tablet


Oral use




Luxembourg







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenac sodium


Voltaren-50


50 mg


Gastro-resistant coated tablet


Oral use




Luxembourg







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenac sodium


Voltaren injekt


75 mg


solution for injection


Intramuscular use




Luxembourg







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenac colestyramine


Voltaren resinat


145,6 mg


Capsule, hard


Oral use




Luxembourg







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenac sodium


Voltaren Retard-100


100 mg


Prolonged-release tablet


Oral use




Luxembourg







Novartis Consumer Health S.A.




Medialaan, 40




B-1800 Vilvoorde




Belgium






Diclofenac potassium


Voltatabs


12,5 mg


Coated tablet


Oral use




Malta







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac potassium


Cataflam


25 mg


Coated tablet


Oral use




Malta







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac potassium


Cataflam


50 mg


Coated tablet


Oral use




Malta







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac potassium


Catafast


50 mg


Powder for oral solution


Oral use




Malta







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


Voltaren


12,5 mg


Suppository


Rectal use




Malta







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


Voltaren


50 mg


Suppository


Rectal use




Malta







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


Voltaren


100 mg


Suppository


Rectal use




Malta







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


Voltaren


25 mg


Gastro-resistant tablet


Oral use




Malta







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


Voltaren


50 mg


Gastro-resistant tablet


Oral use




Malta







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


Voltaren


75 mg/3 ml


Solution for injection


Intramuscular use, intravenous use




Malta







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


Voltaren


50 mg


Dispersible tablet


Oral use




Malta







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


Voltaren


75 mg


Modified-release tablet


Oral use




Malta







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


Voltaren


100 mg


Modified-release tablet


Oral use




Malta







Proge Farm S.r.l.




Largo Donegani 4/a




Novara - 28100




Italy






Diclofenac sodium


Fenadol


100 mg


Suppository


Rectal use




Malta







Proge Farm S.r.l.




Largo Donegani 4/a




Novara - 28100




Italy






Diclofenac sodium


Fenadol


100 mg


Modified-release tablet


Oral use




Malta







Medochemie Ltd




1-10 Constantinoupoleos str




P.O. Box 51409




Limassol 3505




Cyprus






Diclofenac potassium


Areston


50 mg


Film-coated tablet


Oral use




Malta







Medochemie Ltd




1-10 Constantinoupoleos str




P.O. Box 51409




Limassol 3505




Cyprus






Diclofenac sodium


Almiral 25 mg tablets


25 mg


Gastro-resistant tablet


Oral use




Malta







Medochemie Ltd




1-10 Constantinoupoleos str




P.O. Box 51409




Limassol 3505




Cyprus






Diclofenac sodium


Almiral 50 mg tablets


50 mg


Gastro-resistant tablet


Oral use




Malta







Medochemie Ltd




1-10 Constantinoupoleos str




P.O. Box 51409




Limassol 3505




Cyprus






Diclofenac sodium


Almiral injection


75 mg/3 ml


Solution for Injection or Infusion


Intramuscular use, intravenous use




Malta







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenac sodium


Olfen-75 Ampoules


75 mg/2 ml


Solution for injection


Intramuscular use




Malta







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenac sodium


Olfen-25 Lactab


25 mg


Film-coated, gastro-resistant tablet


Oral use




Malta







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenac sodium


Olfen-50 Lactab


50 mg


Film-coated, gastro-resistant tablet


Oral use




Malta







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenac sodium


Olfen-100 Rectocaps


100 mg


Suppository


Rectal use




Malta







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenac sodium


Olfen-75 SR Depotabs


75 mg


Modified-release tablet


Oral use




Malta







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenac sodium


Olfen-100 SR Depocaps


100 mg


Modified-release capsule


Oral use




Malta







Remedica Ltd




Limassol Industrial Estate




Aharnon Street




PO Box 51706




CY-3508 Limassol




Cyprus






Diclofenac sodium


Remethan 25 mg Tablets


25 mg


Gastro-resistant tablet


Oral use




Malta







DEMO SA Pharmaceutical Industry




21st km National Road




Athens-Lamia 14568




Athens




Greece






Diclofenac sodium


Urigon 75 mg/3 ml solution for injection


75 mg/3 ml


Solution for injection


Intramuscular use




Norway







Orifarm Generics A/S




PO 69, Energivej 15




DK-5260 Odense S




Denmark






Diclofenac potassium


Diclofenackalium Orifarm


25 mg


Film-coated tablet


Oral use




Norway







Orifarm Generics A/S




PO 69, Energivej 15




DK-5260 Odense S




Denmark






Diclofenac potassium


Diclofenackalium Orifarm


50 mg


Film-coated tablet


Oral use




Norway







Novartis Norge AS




Nydalen Alle 37 A




0484 Oslo




Norway






Diclofenac potassium


Voltarol


12,5 mg


Capsule, soft


Oral use




Norway







Novartis Norge AS




Nydalen Alle 37 A




0484 Oslo




Norway






Diclofenac potassium


Voltarol


25 mg


Capsule, soft


Oral use




Norway







Novartis Norge AS




Nydalen Alle 37 A




0484 Oslo




Norway






Diclofenac potassium


Voltarol


12,5 mg


Film-coated tablet


Oral use




Norway







Novartis Norge AS




Nydalen Alle 37 A




0484 Oslo




Norway






Diclofenac potassium


Voltarol


25 mg


Coated tablet


Oral use




Norway







Novartis Norge AS




Nydalen Alle 37 A




0484 Oslo




Norway






Diclofenac potassium


Cataflam


12,5 mg


Coated tablet


Oral use




Norway







Novartis Norge AS




Nydalen Alle 37 A




0484 Oslo




Norway






Diclofenac potassium


Cataflam


50 mg


Coated tablet


Oral use




Norway







Novartis Norge AS




Nydalen Alle 37 A




0484 Oslo




Norway






Diclofenac potassium


Cataflam


50 mg


Powder for oral solution


Oral use




Norway







Vitabalans OY




Varastokatu 8




FI-135 000 Hämeenlinna




Finland






Diclofenac potassium


Dicuno


25 mg


Film-coated tablet


Oral use




Norway







Vitabalans OY




Varastokatu 8




FI-135 000 Hämeenlinna




Finland






Diclofenac potassium


Dicuno


50 mg


Film-coated tablet


Oral use




Norway







Mimer Medical




Svärdvägen 3B




SE-182 33 Danderyd




Sweden






Diclofenac potassium


Difenassium


25 mg


Film-coated tablet


Oral use




Norway







Mimer Medical




Svärdvägen 3B




SE-182 33 Danderyd




Sweden






Diclofenac potassium


Difenassium


50 mg


Film-coated tablet


Oral use




Norway







Actavis Group PTC ehf




Reykjavikurvegi 76-78




IS-220 Hafnarfjördur




Iceæand






Diclofenac potassium


Diclofenac Actavis


12,5 mg


Film-coated tablet


Oral use




Norway







Actavis Group PTC ehf




Reykjavikurvegi 76-78




IS-220 Hafnarfjördur




Iceæand






Diclofenac sodium


Modifenac


75 mg


Modified- release capsule, hard


Oral use




Norway







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac potassium


DiclofenacKalium ratiopharm


50 mg


Film-coated tablet


Oral use




Norway







Pfizer AS




Lilleakerveien 2B




1324 Lysaker




Norway






Diclofenac sodium
Misoprostol


Arthrotec


50 mg
0,2 mg


Modified-release tablet


Oral use




Norway







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac sodium


Diclofenac ratiopharm


25 mg


Gastro-resistant tablet


Oral use




Norway







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac sodium


Diclofenac ratiopharm


50 mg


Gastro-resistant tablet


Oral use




Norway







Novartis Norge AS




Nydalen Alle 37 A




0484 Oslo




Norway






Diclofenac sodium


Voltaren


25 mg


Gastro-resistant tablet


Oral use




Norway







Novartis Norge AS




Nydalen Alle 37 A




0484 Oslo




Norway






Diclofenac sodium


Voltaren


50 mg


Gastro-resistant tablet


Oral use




Norway







Novartis Norge AS




Nydalen Alle 37 A




0484 Oslo




Norway






Diclofenac sodium


Voltaren


25 mg/ml


Solution for infusion /Concentrate for solution for infusion


Parenteral use




Norway







BMM Pharma AB




Blasieholmsgatan 2




SE-111 48 Stockholm




Sweden






Diclofenac sodium


Diclofenac BMM Pharma


25 mg


Gastro-resistant tablet


Oral use




Norway







BMM Pharma AB




Blasieholmsgatan 2




SE-111 48 Stockholm




Sweden






Diclofenac sodium


Diclofenac BMM Pharma


50 mg


Gastro-resistant tablet


Oral use




Norway







Novartis Norge AS




Nydalen Alle 37 A




0484 Oslo




Norway






Diclofenac sodium


Voltaren


25 mg


Suppository


Rectal use




Norway







Novartis Norge AS




Nydalen Alle 37 A




0484 Oslo




Norway






Diclofenac sodium


Voltaren


50 mg


Suppository


Rectal use




Norway







Novartis Norge AS




Nydalen Alle 37 A




0484 Oslo




Norway






Diclofenac sodium


Voltaren


100 mg


Suppository


Rectal use




Poland







Actavis Group PTC ehf




Reykjavikurvegi 76-78




IS-220 Hafnarfjördur




Iceæand






Diclofenac potassium


Vostar


12,5 mg


Film-coated tablet


Oral use




Poland







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenacum natricum


Dicloreum


50 mg


Gastro-resistant film-coated tablet


Oral use




Poland







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenacum natricum


Dicloreum


25 mg/ml


Solution for injection


Intramuscular use




Poland







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenacum natricum


Dicloreum retard


100 mg


Prolonged-release capsule


Oral use




Poland







Berlin-Chemie AG




(Menarini Group)




Glienicker Weg 125




12489 Berlin




Germany






Diclofenacum natricum


Dicloberl retard


100 mg


Prolonged-release capsule


Oral use




Poland







Berlin-Chemie AG




(Menarini Group)




Glienicker Weg 125




12489 Berlin




Germany






Diclofenacum natricum


Dicloberl 50


50 mg


Suppository


Rectal use




Poland







GlaxoSmithKline Pharmaceuticals S.A.




Grunwaldzka 189




Poznań 60-322




Poland






Diclofenacum natricum


Diclofenac GSK


50 mg


Suppository


Rectal use




Poland







GlaxoSmithKline Pharmaceuticals S.A.




Grunwaldzka 189




Poznań 60-322




Poland






Diclofenacum natricum


Diclofenac GSK


100 mg


Suppository


Rectal use




Poland







Krka, d.d.




Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






Diclofenacum natricum


Naklofen


25 mg/ml


Solution for injection


Intramuscular use




Poland







Krka, d.d.




Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






Diclofenacum natricum


Naklofen Duo


75 mg


Prolonged-release capsule


Oral use




Poland







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenacum natricum


Olfen 100


100 mg


Rectal capsule


Rectal use




Poland







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenacum natricum


Olfen 50


50 mg


Rectal capsule


Rectal use




Poland







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenacum natricum
Lidocaini hydrochloridum


Olfen 75


37,5 mg/ml
10 mg/ml


Solution for injection


Intramuscular use




Poland







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenacum natricum


Olfen 100 SR


100 mg


Prolonged-release capsule


Oral use




Poland







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenacum natricum


Olfen 25


25 mg


Film-coated tablet


Oral use




Poland







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenacum natricum


Olfen 50


50 mg


Film-coated tablet


Oral use




Poland







Novartis Consumer Health GmbH




Zielstattstrasse 40




Munchen 81379




Germany






Diclofenac potassium


Voltaren Acti


12,5 mg


Film-coated tablet


Oral use




Poland







Novartis Consumer Health GmbH




Zielstattstrasse 40




Munchen 81379




Germany






Diclofenac potassium


Voltaren Express


12,5 mg


Capsule, soft


Oral use




Poland







Novartis Consumer Health GmbH




Zielstattstrasse 40




Munchen 81379




Germany






Diclofenac potassium


Voltaren Acti Forte


25 mg


Film-coated tablet


Oral use




Poland







Novartis Consumer Health GmbH




Zielstattstrasse 40




Munchen 81379




Germany






Diclofenac potassium


Voltaren Express Forte


25 mg


Capsule, soft


Oral use




Poland







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenac potassium


Cataflam 50


50 mg


Film-coated tablet


Oral use




Poland







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenacum natricum


Voltaren


25 mg/ml


Solution for injection


Intramuscular use, Intravenous use




Poland







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenacum natricum


Voltaren


50 mg


Gastro-resistant tablet


Oral use




Poland







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenacum natricum


Voltaren SR 100


100 mg


Prolonged-release tablet


Oral use




Poland







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenacum natricum


Voltaren SR 75


75 mg


Prolonged-release tablet


Oral use




Poland







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenacum natricum


Voltaren


50 mg


Suppository


Rectal use




Poland







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenacum natricum


Voltaren


25 mg


Suppository


Rectal use




Poland







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenacum natricum


Voltaren


100 mg


Suppository


Rectal use




Poland







Pfizer Europe MA EEIG




Ramsgate Road




Kent, Sandwich CT13 9NJ




United Kingdom






Diclofenacum
Misoprostolum


Arthrotec Forte


75 mg
0,2 mg


Tablet


Oral use




Poland







Pfizer Europe MA EEIG




Ramsgate Road




Kent, Sandwich CT13 9NJ




United Kingdom






Diclofenacum natricum
Misoprostolum


Arthrotec


50 mg
0,2 mg


Tablet


Oral use




Poland







PharmaSwiss Česká republika s.r.o.




Jankovcova 1569/2c




170 00 Praha 7 - Holešovice




Czech Republic






Diclofenacum natricum


DicloDuo


75 mg


Modified-release capsule


Oral use




Poland







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenacum


Dicloratio Retard 100


100 mg


Prolonged-release capsule


Oral use




Poland







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenacum


Dicloratio 25


25 mg


Gastro-resistant tablet


Oral use




Poland







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenacum
Lidocainum


Dicloratio


75 mg/2 ml
20 mg/2 ml


Solution for injection


Intramuscular use




Poland







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenacum


Dicloratio 50


50 mg


Gastro-resistant tablet


Oral use




Poland







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenacum


Olfen UNO


150 mg


Prolonged-release capsule


Oral use




Poland







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenacum


Dicloratio 100


100 mg


Suppository


Rectal use




Poland







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenacum


Dicloratio 50


50 mg


Suppository


Rectal use




Poland







Sandoz GmbH




Biochemiestraße 10




Kundl A-6250




Austria






Diclofenacum natricum


Diclac


75 mg/3 ml


Solution for injection


Intramuscular use




Poland







Sandoz GmbH




Biochemiestraße 10




Kundl A-6250




Austria






Diclofenacum natricum


Diclac 75 Duo


75 mg


Modified-release tablet


Oral use




Poland







Sandoz GmbH




Biochemiestraße 10




Kundl A-6250




Austria






Diclofenacum natricum


Diclac 150 Duo


150 mg


Modified-release tablet


Oral use




Poland







Sandoz GmbH




Biochemiestraße 10




Kundl A-6250




Austria






Diclofenacum natricum


Diclac 100


100 mg


Suppository


Rectal use




Poland







Sandoz GmbH




Biochemiestraße 10




Kundl A-6250




Austria






Diclofenacum natricum


Diclac 50


50 mg


Suppository


Rectal use




Poland







Vitabalans OY




Varastokatu 8




FI-135 000 Hämeenlinna




Finland






Diclofenac potassium


Dicuno


25 mg


Film-coated tablet


Oral use




Poland







Vitabalans OY




Varastokatu 8




FI-135 000 Hämeenlinna




Finland






Diclofenac potassium


Dicuno


50 mg


Film-coated tablet


Oral use




Poland







Warszawskie Zakłady Farmaceutyczne POLFA S.A.




ul. Karolkowa 22/24




Warszawa 01-207




Poland






Diclofenacum natricum


Difadol


25 mg/ml


Solution for injection


Intramuscular use, Intravenous use




Poland







Zakłady Farmaceutyczne POLPHARMA S.A.




ul. Pelplińska 19




Starogard Gdański 83-200




Poland






Diclofenacum natricum


Majamil prolongatum


100 mg


Prolonged-release capsule


Oral use




Poland







Zakłady Farmaceutyczne POLPHARMA S.A.




ul. Pelplińska 19




Starogard Gdański 83-200




Poland






Diclofenacum natricum


Majamil PPH


25 mg


Gastro-resistant tablet


Oral use




Poland







Zakłady Farmaceutyczne POLPHARMA S.A.




ul. Pelplińska 19




Starogard Gdański 83-200




Poland






Diclofenacum natricum


Majamil PPH


50 mg


Gastro-resistant tablet


Oral use




Portugal







Laboratórios Pfizer, Lda.




Lagoas Park, Edifício 10




2740-271 Porto Salvo




Portugal






Diclofenac
Misoprostol


Arthrotec


50 mg
0,2 mg


Tablet


Oral use




Portugal







Laboratórios Pfizer, Lda.




Lagoas Park, Edifício 10




2740-271 Porto Salvo




Portugal






Diclofenac
Misoprostol


Arthrotec 75


75 mg
0,2 mg


Modified-release tablet


Oral use




Portugal







Alter, S.A.




Estrada Marco do Grilo - Zemouto




2830 Coina




Portugal






Diclofenac


Diclofenac Alter 50 mg Comprimidos


50 mg


Coated tablet


Oral use




Portugal







Generis Farmacêutica, S.A.




Rua João de Deus, 19




2700-487 Amadora




Portugal






Diclofenac


Diclofenac Generis 50 mg Comprimidos Revestidos


50 mg


Coated tablet


Oral use




Portugal







Labesfal - Laboratórios Almiro S.A.




Zona Industrial do Lagedo




3465-157 Santiago de Besteiros




Portugal






Diclofenac


Diclofenac Labesfal


100 mg


Suppository


Rectal use




Portugal







Labesfal - Laboratórios Almiro S.A.




Zona Industrial do Lagedo




3465-157 Santiago de Besteiros




Portugal






Diclofenac


Diclofenac Labesfal


100 mg


Prolonged-release capsule, hard


Oral use




Portugal







Labesfal - Laboratórios Almiro S.A.




Zona Industrial do Lagedo




3465-157 Santiago de Besteiros




Portugal






Diclofenac


Diclofenac Labesfal


50 mg


Gastro-resistant tablet


Oral use




Portugal







Labesfal - Laboratórios Almiro, S.A.




Campo de Besteiros




3465-051 Santiago de Besteiros




Portugal






Diclofenac


Diclofenac Labesfal 75 mg/3 ml Solução injectável


75 mg/3 ml


Solution for injection


Intramuscular use, Intravenous use




Portugal







Mylan, Lda.




Rua Doutor António Loureiro Borges




Edíficio Arquiparque 1




R/C Esqo





1499-016 Algés




Portugal






Diclofenac


Diclofenac Mylan


100 mg


Prolonged-release capsule, hard


Oral use




Portugal







Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda




Rua Quinta do Pinheiro




Edifício Tejo - 6o Piso




2790-143 Carnaxide




Portugal






Diclofenac


Diclofenac Ratiopharm


50 mg


Gastro-resistant tablet


Oral use




Portugal







Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda




Rua Quinta do Pinheiro




Edifício Tejo - 6o Piso




2790-143 Carnaxide




Portugal






Diclofenac


Diclofenac Ratiopharm 100 mg Supositórios


100 mg


Suppository


Rectal use




Portugal







Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda




Rua Quinta do Pinheiro




Edifício Tejo - 6o Piso




2790-143 Carnaxide




Portugal






Diclofenac


Diclofenac Retard Ratiopharm


100 mg


Prolonged-release capsule, hard


Oral use




Portugal







Sandoz Farmacêutica, Lda.




Alameda da Beloura




Edifício 1, 2o - Escritório 15




2710-693 Sintra




Portugal






Diclofenac


Diclofenac Sandoz 50 mg Comprimidos revestidos


50 mg


Coated tablet


Oral use




Portugal







Labesfal - Laboratórios Almiro S.A.




Zona Industrial do Lagedo




3465-157 Santiago de Besteiros




Portugal






Diclofenac


Dolacen


75 mg/2 ml


Solution for injection


Intramuscular use




Portugal







Laboratório B. A. Farma, Lda.




Rua Prof. Sousa da Câmara, 207 - 211




1074-803 Lisboa




Portugal






Diclofenac


Dorcalor


50 mg


Gastro-resistant tablet


Oral use




Portugal







Laboratórios Vitória, S.A.




Rua Elias Garcia, 28 - Venda Nova




2700-327 Amadora




Portugal






Diclofenac


Fenil-V


75 mg/2 ml


Solution for injection


Intramuscular use




Portugal







Laboratórios Vitória, S.A.




Rua Elias Garcia, 28 - Venda Nova




2700-327 Amadora




Portugal






Diclofenac


Fenil-V


100 mg


Suppository


Rectal use




Portugal







Laboratórios Vitória, S.A.




Rua Elias Garcia, 28 - Venda Nova




2700-327 Amadora




Portugal






Diclofenac


Fenil-V


50 mg


Gastro-resistant tablet


Oral use




Portugal







Laboratórios Vitória, S.A.




Rua Elias Garcia, 28 - Venda Nova




2700-327 Amadora




Portugal






Diclofenac


Fenil-V Retard


100 mg


Prolonged-release capsule, hard


Oral use




Portugal







Laboratório Normal - Produtos Farmacêuticos, Lda.




Rua do Centro Empresarial




Edifício 8, Quinta da Beloura




2710-444 Sintra




Portugal






Diclofenac


Flameril


75 mg/3 ml


Solution for injection


Intramuscular use, Intravenous use




Portugal







Laboratório Normal - Produtos Farmacêuticos, Lda.




Rua do Centro Empresarial




Edifício 8, Quinta da Beloura




2710-444 Sintra




Portugal






Diclofenac


Flameril


100 mg


Suppository


Rectal use




Portugal







Laboratório Normal - Produtos Farmacêuticos, Lda.




Rua do Centro Empresarial




Edifício 8, Quinta da Beloura




2710-444 Sintra




Portugal






Diclofenac


Flameril


50 mg


Gastro-resistant tablet


Oral use




Portugal







Laboratório Normal - Produtos Farmacêuticos, Lda.




Rua do Centro Empresarial




Edifício 8, Quinta da Beloura




2710-444 Sintra




Portugal






Diclofenac


Flameril Retard


100 mg


Prolonged-release tablet


Oral use




Portugal







Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Diclofenac


Olfen


50 mg


Gastro-resistant tablet


Oral use




Portugal







Confar - Consórcio Farmacêutico, Lda.




Rua Félix Correia, 1-B




1500-271 Lisboa




Portugal






Diclofenac


Painex 25


25 mg


Coated tablet


Oral use




Portugal







Confar - Consórcio Farmacêutico, Lda.




Rua Félix Correia, 1-B




1500-271 Lisboa




Portugal






Diclofenac


Painex 50


50 mg


Coated tablet


Oral use




Portugal







Confar - Consórcio Farmacêutico, Lda.




Rua Félix Correia, 1-B




1500-271 Lisboa




Portugal






Diclofenac


Painex R


100 mg


Prolonged-release capsule, hard


Oral use




Portugal







Novartis Farma - Produtos Farmacêuticos, S.A.




Rua do Centro Empresarial




Edifício 8, Quinta da Beloura




2710-444 Sintra




Portugal






Diclofenac


Voltaren


100 mg


Suppository


Rectal use




Portugal







Novartis Farma - Produtos Farmacêuticos, S.A.




Rua do Centro Empresarial




Edifício 8, Quinta da Beloura




2710-444 Sintra




Portugal






Diclofenac


Voltaren


75 mg/3 ml


Solution for injection


Intramuscular use, Intravenous use




Portugal







Novartis Farma - Produtos Farmacêuticos, S.A.




Rua do Centro Empresarial




Edifício 8, Quinta da Beloura




2710-444 Sintra




Portugal






Diclofenac


Voltaren


50 mg


Gastro-resistant tablet


Oral use




Portugal







Novartis Farma - Produtos Farmacêuticos, S.A.




Rua do Centro Empresarial




Edifício 8, Quinta da Beloura




2710-444 Sintra




Portugal






Diclofenac


Voltaren 75


75 mg


Prolonged-release tablet


Oral use




Portugal







Novartis Farma - Produtos Farmacêuticos, S.A.




Rua do Centro Empresarial




Edifício 8, Quinta da Beloura




2710-444 Sintra




Portugal






Diclofenac


Voltaren Retard


100 mg


Prolonged-release tablet


Oral use




Portugal







Laboratório Normal - Produtos Farmacêuticos, Lda.




Rua do Centro Empresarial




Edifício 8, Quinta da Beloura




2710-444 Sintra




Portugal






Diclofenac


Cataflam


50 mg


Coated tablet


Oral use




Portugal







Novartis Consumer Health




Produtos Farmacêuticos e Nutrição, Lda.




Rua do Centro Empresarial,




Edf 8, Quinta da Beloura




2710-693 Sintra




Portugal






Diclofenac


Otriflu


12,5 mg


Coated tablet


Oral use




Portugal







Novartis Consumer Health




Produtos Farmacêuticos e Nutrição, Lda.




Rua do Centro Empresarial,




Edf 8, Quinta da Beloura




2710-693 Sintra




Portugal






Diclofenac


Voltaren 12,5


12,5 mg


Film-coated tablet


Oral use




Portugal







Novartis Consumer Health




Produtos Farmacêuticos e Nutrição, Lda.




Rua do Centro Empresarial,




Edf 8, Quinta da Beloura




2710-693 Sintra




Portugal






Diclofenac


Voltaren 12,5


12,5 mg


Capsule, soft


Oral use




Portugal







Novartis Consumer Health




Produtos Farmacêuticos e Nutrição, Lda.




Rua do Centro Empresarial,




Edf 8, Quinta da Beloura




2710-693 Sintra




Portugal






Diclofenac


Voltaren 25


25 mg


Capsule, soft


Oral use




Portugal







Novartis Farma - Produtos Farmacêuticos, S.A.




Rua do Centro Empresarial




Edifício 8, Quinta da Beloura




2710-444 Sintra




Portugal






Diclofenac


Voltaren Rapid


50 mg


Coated tablet


Oral use




Portugal







Laboratórios Vitória, S.A.




Rua Elias Garcia, 28 - Venda Nova




2700-327 Amadora




Portugal






Diclofenac


Fenil-V Dispersivel


46,5 mg


Dispersible tablet


Oral use




Romania







PharmaSwiss Česká republika s.r.o.




Jankovcova 1569/2c




170 00 Praha 7 - Holešovice




Czech Republic






Diclofenacum


DICLOFENAC DUO PHARMASWISS 75 mg


75 mg


Prolonged-release capsule, hard


Oral use




Romania







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenacum


DICLOREUM 150 mg


150 mg


Prolonged-release capsule, hard


Oral use




Romania







Gerot Pharmazeutika GmbH




Arnethgasse 3




A-1160 Vienna




Austria






Diclofenacum


TRATUL 50 mg


50 mg


Gastro-resistant capsule, soft


Oral use




Romania







S.C. TERAPIA S.A.




Str. Fabricii nr. 124




Cluj-Napoca 400 632




România






Diclofenacum


DICLOTARD® 100 mg


100 mg


Prolonged-release tablet


Oral use




Romania







Hexal AG




Industriestraße 25




D-83607 Holzkirchen




Germany






Diclofenacum


DICLAC® 75 ID


75 mg


Modified-release tablet


Oral use




Romania







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenacum


VOLTAREN® RETARD


100 mg


Prolonged-release tablet


Oral use




Romania







STADA HEMOFARM S.R.L.




Str. Zugrav Nedelcu nr. 3, Timișoara




Județul Timiș




România






Diclofenacum


REFEN® RETARD


100 mg


Prolonged-release tablet


Oral use




Romania







S.C. AC HELCOR PHARMA SRL




Str. Victor Babeș nr. 50




Baia-Mare




Jud. Maramureș 430092




România






Diclofenacum


DICLOFENAC 50 mg


50 mg


Gastro-resistant tablet


Oral use




Romania







SC ANTIBIOTICE SA




Str. Valea Lupului nr. 1




6600-Iași




România






Diclofenacum


CLAFEN 50 mg


50 mg


Gastro-resistant tablet


Oral use




Romania







FARAN LABORATORIES S.A.




17 km Athens-Lamia




Achaias și Trizinas




145 64 Nea Kifisia




Greece






Diclofenacum


RHEUMAVEK


25 mg


Gastro-resistant tablet


Oral use




Romania







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenacum


VOLTAREN® 50


50 mg


Gastro-resistant tablet


Oral use




Romania







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenacum


VOLTAREN® 25


25 mg


Gastro-resistant tablet


Oral use




Romania







S.C. TERAPIA S.A.




Str. Fabricii nr. 124




Cluj-Napoca 400 632




România






Diclofenacum


DICLOFENAC 50 mg


50 mg


Gastro-resistant tablet


Oral use




Romania







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenacum


VOLTAREN RAPID®


50 mg


Coated tablet


Oral use




Romania







S.C. ARENA GROUP S.A.




Str. Stefan Mihaileanu




nr. 31, sector 2;




Bucuresti




România






Diclofenacum


DICLOFENAC ARENA 50 mg


25 mg


Coated tablet


Oral use




Romania







S.C. ARENA GROUP S.A.




Str. Stefan Mihaileanu




nr. 31, sector 2;




Bucuresti




România






Diclofenacum


DICLOFENAC ARENA 50 mg


50 mg


Coated tablet


Oral use




Romania







S.C. MEDUMAN S.A.




Str. Aleea Eroilor nr. 28




Vișeu de Sus




Județul Maramureș 435700




România






Diclofenacum


N - DICLOFENAC


50 mg


Coated tablet


Oral use




Romania







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenacum


VOLTAREN®


25 mg/ml


Solution for injection


Intramuscular use, Intravenous use




Romania







ALIUD PHARMA GmbH & Co. KG




Gottlieb Daimler Strasse 19




D-89150 Laichingen




Germany






Diclofenacum


DICLOFENAC AL I.M.


75 mg/3 ml


Solution for injection


Intramuscular use




Romania







Gerot Pharmazeutika GmbH




Arnethgasse 3




A-1160 Vienna




Austria






Diclofenacum


TRATUL®


30 mg/ml


Solution for injection


Intramuscular use




Romania







Medochemie Ltd




1-10 Constantinoupoleos str




P.O. Box 51409




Limassol 3505




Cyprus






Diclofenacum


ALMIRAL


75 mg/3 ml


Solution for injection


Intramuscular use, Intravenous use




Romania







S.C. TERAPIA S.A.




Str. Fabricii nr. 124




Cluj-Napoca 400 632




România






Diclofenacum


DICLOFENAC 75 mg


75 mg/3 ml


Solution for injection


Intramuscular use




Romania







STADA HEMOFARM S.R.L.




Str. Zugrav Nedelcu nr. 3, Timișoara




Județul Timiș




România






Diclofenacum


REFEN 75 mg


25 mg/ml


Solution for injection


Intramuscular use, Intravenous use




Romania







FARAN LABORATORIES S.A.




17 km Athens-Lamia




Achaias și Trizinas




145 64 Nea Kifisia




Greece






Diclofenacum


RHEUMAVEK


25 mg/ml


Solution for injection


Intramuscular use




Romania







Gerot Pharmazeutika GmbH




Arnethgasse 3




A-1160 Vienna




Austria






Diclofenacum


TRATUL 120 mg


120 mg


Suppository


Rectal use




Romania







Gerot Pharmazeutika GmbH




Arnethgasse 3




A-1160 Vienna




Austria






Diclofenacum


TRATUL 60 mg


60 mg


Suppository


Rectal use




Romania







SC ANTIBIOTICE SA




Str. Valea Lupului nr. 1




6600-Iași




România






Diclofenacum


CLAFEN 100 mg


100 mg


Suppository


Rectal use




Romania







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenacum


VOLTAREN®


100 mg


Suppository


Rectal use




Romania







Novartis Pharma GmbH




Roonstrasse 25




Nuernberg D-90429




Germany






Diclofenacum


VOLTAREN®


50 mg


Suppository


Rectal use




Romania







S.C. MAGISTRA C&C S.R.L.




B-dul Aurel Vlaicu nr. 82A




Constanța 900055




România






Diclofenacum


DICLOFENAC SODIC 100 mg


100 mg


Suppository


Rectal use




Romania







S.C. MAGISTRA C&C S.R.L.




B-dul Aurel Vlaicu nr. 82A




Constanța 900055




România






Diclofenacum


DICLOFENAC 100 mg


100 mg


Suppository


Rectal use




Romania







Fresenius Kabi Austria GmbH




Hafnerstrasse 36




Graz A-8055




Austria






Diclofenac sodium
Orphenadrine citrate


Neodolpasse


75 mg/250 ml
30 mg/250 ml


Solution for infusion


Intravenous use




Romania







PFIZER EUROPE MA EEIG




Ramsgate Road




Sandwich




Kent CT13 9NJ




United Kingdom






Diclofenacu
Misoprostolum


ARTHROTEC 75


75 mg
0,2 mg


Gastro –
resistant tablet


Oral use




Romania







Lannacher Heilmittel Ges.m.b.H




Schlossplatz 1




8502 Lannach




Austria






Diclofenac sodium
Thiamine hydrochloride
Pyridoxine hydrochloride
Cyanocobalamin


TRATUL PLUS


50 mg
50 mg
50 mg
0,25 mg


Gastro –
resistant tablet


Oral use




Slovak Republic







MEDOPHARM s.r.o., Lehárova 1808/11




143 00, Praha 4




Czech Republic






Diclofenac


ALMIRAL


75 mg/3 ml


Solution for injection


Intramuscular use, Intravenous use




Slovak Republic







Medochemie Ltd




1-10 Constantinoupoleos str




P.O. Box 51409




Limassol 3505




Cyprus






Diclofenac


ALMIRAL 50 mg


50 mg


Gastro-resistant tablet


Oral use




Slovak Republic







Hexal AG




Industriestraße 25




D-83607 Holzkirchen




Germany






Diclofenac


Diclac retard


100 mg


Prolonged-release tablet


Oral use




Slovak Republic







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac


Diclobene 150 mg retard


150 mg


Prolonged-release tablet


Oral use




Slovak Republic







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac


Diclobene 25 mg


25 mg


Gastro-resistant tablet


Oral use




Slovak Republic







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac


Diclobene 50 mg


50 mg


Gastro-resistant tablet


Oral use




Slovak Republic







ALIUD PHARMA GmbH & Co. KG




Gottlieb Daimler Strasse 19




D-89150 Laichingen




Germany






Diclofenac


Diclofenac AL 25


25 mg


Gastro-resistant tablet


Oral use




Slovak Republic







ALIUD PHARMA GmbH & Co. KG




Gottlieb Daimler Strasse 19




D-89150 Laichingen




Germany






Diclofenac


Diclofenac AL 50


50 mg


Gastro-resistant tablet


Oral use




Slovak Republic







ALIUD PHARMA GmbH & Co. KG




Gottlieb Daimler Strasse 19




D-89150 Laichingen




Germany






diclofenac


Diclofenac AL retard


100 mg


Prolonged-release tablet


Oral use




Slovak Republic







PharmaSwiss Česká republika s.r.o.




Jankovcova 1569/2c




170 00 Praha 7 - Holešovice




Czech Republic






Diclofenac


Diclofenac Duo PharmaSwiss 75 mg


75 mg


Modified-release capsule


Oral use




Slovak Republic







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenac


DICLOREUM 25 mg


25 mg


Gastro-resistant tablet


Oral use




Slovak Republic







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenac


DICLOREUM 50 mg


50 mg


Gastro-resistant tablet


Oral use




Slovak Republic







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenac


DICLOREUM 50 mg


50 mg


Suppository


Rectal use




Slovak Republic







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenac


DICLOREUM 100 mg


100 mg


Suppository


Rectal use




Slovak Republic







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






diclofenac


DICLOREUM 75 mg


75 mg/3 ml


Solution for injection


Intramuscular use




Slovak Republic







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenac


DICLOREUM retard


100 mg


Prolonged-release tablet


Oral use




Slovak Republic







Vitabalans OY




Varastokatu 8




FI-135 000 Hämeenlinna




Finland






Diclofenac


Dicuno 25 mg filmom obalené tablety


25 mg


Film-coated tablet


Oral use




Slovak Republic







Vitabalans OY




Varastokatu 8




FI-135 000 Hämeenlinna




Finland






Diclofenac


Dicuno 50 mg filmom obalené tablety


50 mg


Film-coated tablet


Oral use




Slovak Republic







Zentiva, k.s.




U kabelovny 130




102 37 Praha 10 - Dolní Měcholupy




Czech Republic






Diclofenac


Dolmina 50


50 mg


Film-coated tablet


Oral use




Slovak Republic







Zentiva, k.s.




U kabelovny 130




102 37 Praha 10 - Dolní Měcholupy




Czech Republic






Diclofenac


DOLMINA INJ


75 mg/3 ml


Solution for injection


Intramuscular use




Slovak Republic







IBSA Slovakia s.r.o.




Mytna 42




811 05 Bratislava




Slovak Republic






Diclofenac


Flector EP Rapid 50 mg


50 mg


Granules


Oral use




Slovak Republic







Dr. R. Pfleger Chemische Fabrik GmbH




Dr. Robert Pfleger Strasse 12




D-96045 Bamberg




Germany






Diclofenac


Myogit 50


50 mg


Gastro-resistant tablet


Oral use




Slovak Republic







Herbacos Recordati s.r.o.




Štrossova 239




53003 Pardubice




Czech Republic






Diclofenac


VERAL 100 mg


100 mg


Suppository


Rectal use




Slovak Republic







Herbacos Recordati s.r.o.




Štrossova 239




53003 Pardubice




Czech Republic






Diclofenac


VERAL 100 retard


100 mg


Prolonged-release tablet


Oral use




Slovak Republic







Herbacos Recordati s.r.o.




Štrossova 239




53003 Pardubice




Czech Republic






Diclofenac


VERAL 25 mg


25 mg


Gastro-resistant tablet


Oral use




Slovak Republic







Herbacos Recordati s.r.o.




Štrossova 239




53003 Pardubice




Czech Republic






Diclofenac


VERAL 50 mg


50 mg


Gastro-resistant tablet


Oral use




Slovak Republic







Herbacos Recordati s.r.o.




Štrossova 239




53003 Pardubice




Czech Republic






Diclofenac


VERAL 75


75 mg/3 ml


Solution for injection


Intramuscular use




Slovak Republic







Herbacos Recordati s.r.o.




Štrossova 239




53003 Pardubice




Czech Republic






Diclofenac


VERAL 75 retard


75 mg


Prolonged-release tablet


Oral use




Slovak Republic







Novartis s.r.o.




Na Pankraci 1724/129




140 00 Praha 4




Czech Republic






Diclofenac


Voltaren 100


100 mg


Suppository


Rectal use




Slovak Republic







Novartis s.r.o.




Na Pankraci 1724/129




140 00 Praha 4




Czech Republic






Diclofenac


Voltaren 50


50 mg


Gastro-resistant tablet


Oral use




Slovak Republic







Novartis s.r.o.




Na Pankraci 1724/129




140 00 Praha 4




Czech Republic






Diclofenac


Voltaren 75 mg/3 ml


75 mg/3 ml


Solution for injection


Intramuscular use




Slovak Republic







Novartis s.r.o.




Na Pankraci 1724/129




140 00 Praha 4




Czech Republic






Diclofenac


Voltaren Actigo Extra 25 mg


25 mg


Coated tablet


Oral use




Slovak Republic







Novartis s.r.o.




Na Pankraci 1724/129




140 00 Praha 4




Czech Republic






Diclofenac


Voltaren Rapid 12,5 mg


12,5 mg


Capsule, soft


Oral use




Slovak Republic







Novartis s.r.o.




Na Pankraci 1724/129




140 00 Praha 4




Czech Republic






Diclofenac


Voltaren Rapid 25 mg


25 mg


Capsule, soft


Oral use




Slovak Republic







Novartis s.r.o.




Na Pankraci 1724/129




140 00 Praha 4




Czech Republic






Diclofenac


Voltaren Rapid 50 mg


50 mg


Coated tablet


Oral use




Slovak Republic







Novartis s.r.o.




Na Pankraci 1724/129




140 00 Praha 4




Czech Republic






Diclofenac


Voltaren Rapid Sachets


50 mg


Powder for oral solution


Oral use




Slovak Republic







Novartis s.r.o.




Na Pankraci 1724/129




140 00 Praha 4




Czech Republic






Diclofenac


Voltaren Retard 100


100 mg


Prolonged-release tablet


Oral use




Slovak Republic







Novartis s.r.o.




Na Pankraci 1724/129




140 00 Praha 4




Czech Republic






Diclofenac


Voltaren SR 75


75 mg


Prolonged-release tablet


Oral use




Slovak Republic







Pfizer Europe MA EEIG




Ramsgate Road




Kent, Sandwich CT13 9NJ




United Kingdom






Diclofenac
Misoprostol


ARTHROTEC FORTE


75 mg
0,2 mg


Film-coated tablet


Oral use




Slovak Republic







Fresenius Kabi Austria GmbH




Hafnerstrasse 36




Graz A-8055




Austria






Diclofenac
Orphenadrine


Neodolpasse


75 mg/250 ml
30 mg/250 ml


Solution for infusion


Intravenous use




Slovenia







PharmaSwiss d.o.o.




Wolfova 1




1000 Ljubljana




Slovenia






Diclofenac


Diclo Duo 75 mg trde gastrorezistentne kapsule


75 mg


Gastro-resistant capsule, hard


Oral use




Slovenia







PharmaSwiss d.o.o.




Wolfova 1




1000 Ljubljana




Slovenia






Diclofenac


DicloJet 75 mg trde gastrorezistentne kapsule


75 mg


Gastro-resistant capsule, hard


Oral use




Slovenia







Vitabalans OY




Varastokatu 8




FI-135 000 Hämeenlinna




Finland






Diclofenac


Dicuno 25 mg filmsko obložene tablete


25 mg


Film-coated tablet


Oral use




Slovenia







Vitabalans OY




Varastokatu 8




FI-135 000 Hämeenlinna




Finland






Diclofenac


Dicuno 50 mg filmsko obložene tablete


50 mg


Film-coated tablet


Oral use




Slovenia







Krka, d.d.




Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






Diclofenac


Naklofen 25 mg/ml raztopina za injiciranje


25 mg/ml


Solution for injection


Intramuscular use




Slovenia







Krka, d.d.




Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






diclofenac


Naklofen 50 mg gastrorezistentne tablete


50 mg


Gastro-resistant tablet


Oral use




Slovenia







Krka, d.d.




Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






Diclofenac


Naklofen 50 mg svečke


50 mg


Suppository


Rectal use




Slovenia







Krka, d.d.




Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






Diclofenac


Naklofen duo 75 mg trde kapsule


75 mg


Capsule, hard


Oral use




Slovenia







Krka, d.d.




Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






Diclofenac


Naklofen SR 100 mg tablete s podaljšanim sproščanjem


100 mg


Prolonged-release tablet


Oral use




Slovenia







Medias International d.o.o.




Leskoškova cesta 9D




1000 Ljubljana




Slovenia






Diclofenac


Neodolpasse 75 mg/30 mg raztopina za infundiranje


2,5 mg/ml


Solution for infusion


Intravenous use




Slovenia







Pliva Ljubljana d.o.o.




pot k sejmišču 35




1231 Ljubljana Črnuče




Slovenia






Diclofenac


Olfen 100 mg trde kapsule s podaljšanim sproščanjem


100 mg


Prolonged-release capsule, hard


Oral use




Slovenia







Pliva Ljubljana d.o.o.




pot k sejmišču 35




1231 Ljubljana Črnuče




Slovenia






Diclofenac


Voltaren 12,5 mg svečke


12,5 mg


Suppository


Rectal use




Slovenia







Pliva Ljubljana d.o.o.




pot k sejmišču 35




1231 Ljubljana Črnuče




Slovenia






Diclofenac


Voltaren 25 mg svečke


25 mg


Suppository


Rectal use




Slovenia







Novartis Consumer Health GmbH




Zielstattstrasse 40




Munchen 81379




Germany






Diclofenac


Voltaren Dolo 12,5 mg filmsko obložene tablete


12,5 mg


Film-coated tablet


Oral use




Spain







NOVARTIS FARMACEUTICA, S.A.




Gran Vía de les Corts Catalanes, 764




08013 Barcelona




Spain






Diclofenac sodium


VOLTAREN 100 mg supositorios


100 mg


Suppository


Rectal use




Spain







NOVARTIS FARMACEUTICA, S.A.




Gran Vía de les Corts Catalanes, 764




08013 Barcelona




Spain






Diclofenac sodium


VOLTAREN 50 mg comprimidos gastrorresistentes


50 mg


Gastro-resistant tablet


Oral use




Spain







NOVARTIS FARMACEUTICA, S.A.




Gran Vía de les Corts Catalanes, 764




08013 Barcelona




Spain






Diclofenac sodium


DOLO-VOLTAREN 50 mg comprimidos dispersables


50 mg


Orodispersible tablet


Oral use




Spain







NOVARTIS FARMACEUTICA, S.A.




Gran Vía de les Corts Catalanes, 764




08013 Barcelona




Spain






Diclofenac sodium


VOLTAREN RETARD 75 mg comprimidos de liberación modificada


75 mg


Modified-release tablet


Oral use




Spain







NOVARTIS FARMACEUTICA, S.A.




Gran Vía de les Corts Catalanes, 764




08013 Barcelona




Spain






Diclofenac sodium


VOLTAREN RETARD 100 mg comprimidos de liberación modificada


100 mg


Modified-release tablet


Oral use




Spain







NOVARTIS FARMACEUTICA, S.A.




Gran Vía de les Corts Catalanes, 764




08013 Barcelona




Spain






Diclofenac sodium


VOLTAREN 75 mg/3 ml solución inyectable


75 mg/3 ml


Solution for injection


Intramuscular use




Spain







LABORATORIOS ALDO-UNION, S.A.




Baronesa de Malda, 73




08950 Esplugues de Llobregat (Barcelona)




Spain






Diclofenac sodium


DICLOFENACO ALDO-UNION comprimidos EFG


50 mg


Tablet


Oral use




Spain







BEXAL FARMACEUTICA, S.A.




Centro Empresarial Osa Mayor




Avda. Osa Mayor, 4 - Area B




28023 Aravaca (Madrid)




Spain






Diclofenac sodium


DICLOFENACO BEXAL 50 mg comprimidos gastrorresistentes EFG


50 mg


Gastro-resistant tablet


Oral use




Spain







LABORATORIOS STADA, S.L




Frederic Mompou, 5




08960 Sant Just Desvern (Barcelona)




Spain






Diclofenac sodium


DICLOFENACO RETARD STADA 100 mg comprimidos EFG


100 mg


Film-coated tablet


Oral use




Spain







LABORATORIOS STADA, S.L




Frederic Mompou, 5




08960 Sant Just Desvern (Barcelona)




Spain






Diclofenac sodium


DICLOFENACO STADA 50 mg comprimidos EFG


50 mg


Gastro-resistant tablet


Oral use




Spain







LABORATORIOS NORMON, S.A.




Ronda de Valdecarrizo, 6




28760 Tres Cantos (Madrid)




Spain






Diclofenac sodium


DICLOFENACO NORMON 50 mg comprimidos dispersables EFG


50 mg


Orodispersible tablet


Oral use




Spain







LABORATORIOS NORMON, S.A.




Ronda de Valdecarrizo, 6




28760 Tres Cantos (Madrid)




Spain






Diclofenac sodium


DICLOFENACO NORMON 50 mg comprimidos entéricos EFG


50 mg


Gastro-resistant tablet


Oral use




Spain







FAES FARMA, S.A.




Maximo Aguirre, 14




48940 Lamiaco-Lejona (Vizcaya)




Spain






Diclofenac sodium


DOLOTREN 50 mg comprimidos gastrorresistentes


50 mg


Gastro-resistant tablet


Oral use




Spain







FAES FARMA, S.A.




Maximo Aguirre, 14




48940 Lamiaco-Lejona (Vizcaya)




Spain






Diclofenac sodium


DOLOTREN RETARD 100 mg cápsulas duras de liberación prolongada


100 mg


Modified-release hard capsule


Oral use




Spain







FAES FARMA, S.A.




Maximo Aguirre, 14




48940 Lamiaco-Lejona (Vizcaya)




Spain






Diclofenac sodium


DOLOTREN DISPERSABLE comprimidos


50 mg


Orodispersible tablet


Oral use




Spain







FAES FARMA, S.A.




Maximo Aguirre, 14




48940 Lamiaco-Lejona (Vizcaya)




Spain






Diclofenac sodium


DOLOTREN supositorios


100 mg


Suppository


Rectal use




Spain







FAES FARMA, S.A.




Maximo Aguirre, 14




48940 Lamiaco-Lejona (Vizcaya)




Spain






Diclofenac sodium


DOLOTREN ampollas


75 mg/3 ml


Solution for injection


Intramuscular use




Spain







SIGMA TAU ESPAÑA, S.A.




Bolivia, 15




Polígono Industrial Azque




28806 Alcalá de Henares (Madrid)




Spain






Diclofenac sodium


LUASE 50 mg comprimidos


50 mg


Gastro-resistant tablet


Oral use




Spain







LABORATORIOS LLORENS, S.A.




Ciudad de Balaguer, 7-11




08022 Barcelona




Spain






Diclofenac sodium


DICLOFENACO LLORENS 50 mg comprimidos entéricos EFG


50 mg


Gastro-resistant tablet


Oral use




Spain







LABORATORIOS LLORENS, S.A.




Ciudad de Balaguer, 7-11




08022 Barcelona




Spain






Diclofenac sodium


DICLOFENACO LLORENS 75 mg solución inyectable EFG


75 mg/3 ml


Solution for injection


Intramuscular use




Spain







LABORATORIOS LLORENS, S.A.




Ciudad de Balaguer, 7-11




08022 Barcelona




Spain






Diclofenac sodium


DI-RETARD 100 mg comprimidos de liberación modificada


100 mg


Modified-release tablet


Oral use




Spain







LABORATORIOS LLORENS, S.A.




Ciudad de Balaguer, 7-11




08022 Barcelona




Spain






Diclofenac sodium


DICLOFENACO LLORENS 100 mg supositorios EFG


100 mg


Suppository


Rectal use




Spain







RATIOPHARM ESPAÑA, S.A.




Avda. de Burgos, 16 D




5a planta




28036 Madrid




Spain






Diclofenac sodium


DICLOFENACO RATIOPHARM 50 mg comprimidos


50 mg


Coated tablet


Oral use




Spain







LABORATORIOS ALTER, S.A.




Mateo Inurria, 30




28036 Madrid




Spain






Diclofenac sodium


DICLOFENACO ALTER 50 mg comprimidos EFG


50 mg


Gastro-resistant tablet


Oral use




Spain







PENSA PHARMA, S.A.U.




Jorge Comín (médico pediatra), 3-bajos




46015 Valencia




Spain






Diclofenac sodium


DICLOFENACO PENSA 50 mg comprimidos EFG


50 mg


Gastro-resistant tablet


Oral use




Spain







LABORATORIOS CINFA, S.A.




Olaz-Chipi, 10




Polígono Industrial Areta




31620 Huarte-Pamplona (Navarra)




Spain






Diclofenac sodium


DICLOFENACO CINFA 50 mg comprimidos gastrorresistentes EFG


50 mg


Gastro-resistant tablet


Oral use




Spain







SANDOZ FARMACEUTICA, S.A.




Avda. Osa Mayor, 4




28023 Aravaca (Madrid)




Spain






Diclofenac sodium


DICLOFENACO SANDOZ 50 mg comprimidos gastrorresistentes EFG


50 mg


Gastro-resistant tablet


Oral use




Spain







SANDOZ FARMACEUTICA, S.A.




Avda. Osa Mayor, 4




28023 Aravaca (Madrid)




Spain






Diclofenac sodium


DICLOFENACO SANDOZ 100 mg supositorios EFG


100 mg


Suppository


Rectal use




Spain







SANDOZ FARMACEUTICA, S.A.




Avda. Osa Mayor, 4




28023 Aravaca (Madrid)




Spain






Diclofenac sodium


DICLOFENACO SANDOZ RETARD 100 mg comprimidos de liberación modificada EFG


100 mg


Modified-release tablet


Oral use




Spain







LABORATORIOS RANBAXY, S.L.




Passeig de Gracia, 9




08007 Barcelona




Spain






Diclofenac sodium


DICLOFENACO MUNDOGEN 50 mg comprimidos EFG


50 mg


Gastro-resistant tablet


Oral use




Spain







GERMED FARMACEUTICA, S.L.




Chile, 8-2a planta. Oficina 203




28290 Las Matas (Madrid)




Spain






Diclofenac sodium


DICLOFENACO EDIGEN 50 mg comprimidos EFG


50 mg


Gastro-resistant tablet


Oral use




Spain







Pfizer S.L.




Avda. de Europa, 20 B




Parque Empresarial La Moraleja




28108 Alcobendas (Madrid)




Spain






Diclofenac sodium
Misoprostol


ARTROTEC


50 mg
0,2 mg


Film-coated tablet


Oral use




Spain







Pfizer S.L.




Avda. de Europa, 20 B




Parque Empresarial La Moraleja




28108 Alcobendas (Madrid)




Spain






Diclofenac sodium
Misoprostol


NORMULEN


50 mg
0,2 mg


Film-coated tablet


Oral use




Sweden







Novartis Sverige AB




Box 1150




183 11 Täby




Sweden






Diclofenac sodium


Voltaren®


25 mg


Gastro-resistant tablet


Oral use




Sweden







Novartis Sverige AB




Box 1150




183 11 Täby




Sweden






Diclofenac sodium


Voltaren®


50 mg


Gastro-resistant tablet


Oral use




Sweden







Novartis Sverige AB




Box 1150




183 11 Täby




Sweden






Diclofenac potassium


Voltaren® T


12,5 mg


Film-coated tablet


Oral use




Sweden







Novartis Sverige AB




Box 1150




183 11 Täby




Sweden






Diclofenac sodium


Voltaren®


25 mg/ml


Solution for injection


Parenteral use




Sweden







Novartis Sverige AB




Box 1150




183 11 Täby




Sweden






Diclofenac potassium


Voltaren® T


25 mg


Coated tablet


Oral use




Sweden







Novartis Sverige AB




Box 1150




183 11 Täby




Sweden






Diclofenac potassium


Voltaren® T


50 mg


Coated tablet


Oral use




Sweden







Novartis Sverige AB




Box 1150




183 11 Täby




Sweden






Diclofenac potassium


Voltaren® T


12,5 mg


Capsule, soft


Oral use




Sweden







Novartis Sverige AB




Box 1150




183 11 Täby




Sweden






Diclofenac potassium


Voltaren® T


25 mg


Capsule, soft


Oral use




Sweden







Mylan AB




PO 230 33




Ynglingagatan 14




SE-104 35 Stockholm




Sweden






Diclofenac sodium


Diklofenak Mylan


25 mg


Gastro-resistant tablet


Oral use




Sweden







Mylan AB




PO 230 33




Ynglingagatan 14




SE-104 35 Stockholm




Sweden






Diclofenac sodium


Diklofenak Mylan


50 mg


Gastro-resistant tablet


Oral use




Sweden







Pfizer AB




Vetenskapsvägen 10




191 90 Sollentuna




Sweden






Diclofenac
Misoprostol


Arthrotec


50 mg
0,2 mg


Modified-release tablet


Oral use




Sweden







Pfizer AB




Vetenskapsvägen 10




191 90 Sollentuna




Sweden






Diclofenac natrium
Misoprostol


Arthrotec forte


75 mg
0,2 mg


Modified-release tablet


Oral use




Sweden







Sandoz GmbH




Biochemiestraße 10




Kundl A-6250




Austria






Diclofenac sodium


Diklofenak Sandoz


25 mg


Gastro-resistant tablet


Oral use




Sweden







Sandoz GmbH




Biochemiestraße 10




Kundl A-6250




Austria






Diclofenac sodium


Diklofenak Sandoz


50 mg


Gastro-resistant tablet


Oral use




Sweden







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac potassium


Diclofenac T ratiopharm


25 mg


Film-coated tablet


Oral use




Sweden







ratiopharm GmbH




Graf Arco Strasse 3




D-89079 Ulm




Germany






Diclofenac potassium


Diclofenac T ratiopharm


50 mg


Film-coated tablet


Oral use




Sweden







Orifarm Generics A/S




PO 69, Energivej 15




DK-5260 Odense S




Denmark






Diclofenac sodium


Diklofenak Orifarm


25 mg


Gastro-resistant tablet


Oral use




Sweden







Orifarm Generics A/S




PO 69, Energivej 15




DK-5260 Odense S




Denmark






Diclofenac sodium


Diklofenak Orifarm


50 mg


Gastro-resistant tablet


Oral use




Sweden







Meda OTC AB




Östermalmsgatan 19




11426 Stockholm




Sweden






Diclofenac potassium


Eeze


25 mg


Film-coated tablet


Oral use




Sweden







Evolan Pharma AB




Box: 120




182 12 Danderyd




Sweden






Diclofenac potassium


Diklofenak T Evolan


50 mg


Film-coated tablet


Oral use




Sweden







Orifarm Generics A/S




PO 69, Energivej 15




DK-5260 Odense S




Denmark






Diclofenac sodium


Diklofenak T Orifarm


25 mg


Film-coated tablet


Oral use




Sweden







Orifarm Generics A/S




PO 69, Energivej 15




DK-5260 Odense S




Denmark






Diclofenac sodium


Diklofenak T Orifarm


50 mg


Film-coated tablet


Oral use




Sweden







Actavis A/S




Ornegardsvej 16




2820 Gentofte




Denmark






Diclofenac potassium


Diklofenak T Actavis


25 mg


Film-coated tablet


Oral use




Sweden







Actavis A/S




Ornegardsvej 16




2820 Gentofte




Denmark






Diclofenac potassium


Diklofenak T Actavis


50 mg


Film-coated tablet


Oral use




Sweden







Meda OTC AB




Östermalmsgatan 19




11426 Stockholm




Sweden






Diclofenac sodium


Diclofenac BMM Pharma


25 mg


Gastro-resistant tablet


Oral use




Sweden







Meda OTC AB




Östermalmsgatan 19




11426 Stockholm




Sweden






Diclofenac sodium


Diclofenac BMM Pharma


50 mg


Gastro-resistant tablet


Oral use




Sweden







Orion Corporation




Orionintie 1




FI-02200 Espoo




Finland






Diclofenac potassium


Instantin


50 mg


Powder for oral solution


Oral use




Sweden







Meda OTC AB




Östermalmsgatan 19




11426 Stockholm




Sweden






Diclofenac potassium


Eezeneo


25 mg


Film-coated tablet


Oral use




Sweden







Mimer Medical




Svärdvägen 3B




SE-182 33 Danderyd




Sweden






Diclofenac potassium


Eezeneo


50 mg


Film-coated tablet


Oral use




Sweden







Mimer Medical




Svärdvägen 3B




SE-182 33 Danderyd




Sweden






Diclofenac potassium


Eeze


12,5 mg


Film-coated tablet


Oral use




Sweden







Vitabalans OY




Varastokatu 8




FI-135 000 Hämeenlinna




Finland






Diclofenac potassium


Dicuno


25 mg


Film-coated tablet


Oral use




Sweden







Vitabalans OY




Varastokatu 8




FI-135 000 Hämeenlinna




Finland






Diclofenac potassium


Dicuno


50 mg


Film-coated tablet


Oral use




Sweden







Mimer Medical




Svärdvägen 3B




SE-182 33 Danderyd




Sweden






Diclofenac potassium


Diklotab


25 mg


Film-coated tablet


Oral use




Sweden







Mimer Medical




Svärdvägen 3B




SE-182 33 Danderyd




Sweden






Diclofenac potassium


Diklotab


50 mg


Film-coated tablet


Oral use




Sweden







Mimer Medical




Svärdvägen 3B




SE-182 33 Danderyd




Sweden






Diclofenac potassium


Diklok


25 mg


Film-coated tablet


Oral use




Sweden







Mimer Medical




Svärdvägen 3B




SE-182 33 Danderyd




Sweden






Diclofenac potassium


Diklok


50 mg


Film-coated tablet


Oral use




Sweden







Mimer Medical




Svärdvägen 3B




SE-182 33 Danderyd




Sweden






Diclofenac potassium


Kappadi


25 mg


Film-coated tablet


Oral use




Sweden







Mimer Medical




Svärdvägen 3B




SE-182 33 Danderyd




Sweden






Diclofenac potassium


Kappadi


50 mg


Film-coated tablet


Oral use




Sweden







Novartis Sverige AB




Box 1150




183 11 Täby




Sweden






Diclofenac sodium


Voltaren®


100 mg


Suppository


Rectal use




Sweden







Novartis Sverige AB




Box 1150




183 11 Täby




Sweden






Diclofenac sodium


Voltaren®


50 mg


Suppository


Rectal use




Sweden







Novartis Sverige AB




Box 1150




183 11 Täby




Sweden






Diclofenac sodium


Voltaren®


25 mg


Suppository


Rectal use




Sweden







Mylan AB




PO 230 33




Ynglingagatan 14




SE-104 35 Stockholm




Sweden






Diclofenac sodium


Diklofenak Mylan


100 mg


Suppository


Rectal use




Sweden







Mylan AB




PO 230 33




Ynglingagatan 14




SE-104 35 Stockholm




Sweden






Diclofenac sodium


Diklofenak Mylan


50 mg


Suppository


Rectal use




The Netherlands







Actavis B.V.




Baarnsche Dijk 1




3741 LN Baarn




The Netherlands






Diclofenac sodium


Diclofenacnatrium Actavis 25 mg, maagsapresistente tabletten


25 mg


Gastro-resistant tablet


Oral use




The Netherlands







Actavis B.V.




Baarnsche Dijk 1




3741 LN Baarn




The Netherlands






Diclofenac sodium


Diclofenacnatrium Actavis 50 mg, maagsapresistente tabletten


50 mg


Gastro-resistant tablet


Oral use




The Netherlands







Actavis B.V.




Baarnsche Dijk 1




3741 LN Baarn




The Netherlands






Diclofenac sodium


Diclofenacnatrium Actavis Retard 75 mg, tabletten met gereguleerde afgifte


75 mg


Modified-release tablet


Oral use




The Netherlands







Actavis B.V.




Baarnsche Dijk 1




3741 LN Baarn




The Netherlands






Diclofenac sodium


Diclofenacnatrium Actavis Retard 100 mg, tabletten met gereguleerde afgifte


100 mg


Modified-release tablet


Oral use




The Netherlands







Actavis B.V.




Baarnsche Dijk 1




3741 LN Baarn




The Netherlands






Diclofenac sodium


Diclofenacnatrium Actavis 25 mg, zetpillen


25 mg


Suppository


Rectal use




The Netherlands







Actavis B.V.




Baarnsche Dijk 1




3741 LN Baarn




The Netherlands






Diclofenac sodium


Diclofenacnatrium Actavis 50 mg, zetpillen


50 mg


Suppository


Rectal use




The Netherlands







Actavis B.V.




Baarnsche Dijk 1




3741 LN Baarn




The Netherlands






Diclofenac sodium


Diclofenacnatrium Actavis 100 mg, zetpillen


100 mg


Suppository


Rectal use




The Netherlands







Actavis Group PTC ehf




Reykjavikurvegi 76-78




IS-220 Hafnarfjördur




Iceæand






Diclofenac potassium


Diclofenac Kalium Actavis 12,5 mg, filmomhulde tabletten


12,5 mg


Film-coated tablet


Oral use




The Netherlands







Alfa Wassermann S.p.A.




Via Enrico Fermi 1




Alanno (PE) 65020




Italy






Diclofenac potassium


Eminocs 50 mg/ml, drank


50 mg


Oral drops, solution


Oral use




The Netherlands







Apotex Europe B.V.




Darwinweg 20




2333 CR Leiden




The Netherlands






Diclofenac sodium


Diclofenacnatrium Apotex 25 mg, maagsapresistente tabletten


25 mg


Gastro-resistant tablet


Oral use




The Netherlands







Apotex Europe B.V.




Darwinweg 20




2333 CR Leiden




The Netherlands






Diclofenac sodium


Diclofenacnatrium Apotex 50 mg, maagsapresistente tabletten


50 mg


Gastro-resistant tablet


Oral use




The Netherlands







Apotex Europe B.V.




Darwinweg 20




2333 CR Leiden




The Netherlands






Diclofenac sodium


Diclofenacnatrium Apotex retard 100 mg, tabletten met gereguleerde afgifte


100 mg


Modified-release tablet


Oral use




The Netherlands







Apotex Europe B.V.




Darwinweg 20




2333 CR Leiden




The Netherlands






Diclofenac sodium


Diclofenacnatrium Apotex 25 mg, zetpillen


25 mg


Suppository


Rectal use




The Netherlands







Apotex Europe B.V.




Darwinweg 20




2333 CR Leiden




The Netherlands






Diclofenac sodium


Diclofenacnatrium Apotex 50 mg, zetpillen


50 mg


Suppository


Rectal use




The Netherlands







Apotex Europe B.V.




Darwinweg 20




2333 CR Leiden




The Netherlands






Diclofenac sodium


Diclofenacnatrium Apotex 100 mg, zetpillen


100 mg


Suppository


Rectal use




The Netherlands







Centrafarm B.V.




Nieuwe Donk 3




4879 AC Etten Leur




The Netherlands






Diclofenac sodium


Diclofenac Na CF 25 mg/ml, oplossing voor injectie


25 mg/ml


Solution for injection


Intramuscular use, Intravenous use




The Netherlands







Centrafarm B.V.




Nieuwe Donk 3




4879 AC Etten Leur




The Netherlands






Diclofenac sodium


Diclofenac Na CF 25 mg, maagsapresistente tabletten


25 mg


Gastro-resistant tablet


Oral use




The Netherlands







Centrafarm B.V.




Nieuwe Donk 3




4879 AC Etten Leur




The Netherlands






Diclofenac sodium


Diclofenac Na CF 50 mg, maagsapresistente tabletten


50 mg


Gastro-resistant tablet


Oral use




The Netherlands







Centrafarm B.V.




Nieuwe Donk 3




4879 AC Etten Leur




The Netherlands






Diclofenac sodium


Diclofenac Na zetpil CF 50 mg, zetpillen


50 mg


Suppository


Rectal use




The Netherlands







Centrafarm B.V.




Nieuwe Donk 3




4879 AC Etten Leur




The Netherlands






Diclofenac sodium


Diclofenac Na zetpil CF 100 mg, zetpillen


100 mg


Suppository


Rectal use




The Netherlands







Centrafarm B.V.




Nieuwe Donk 3




4879 AC Etten Leur




The Netherlands






Diclofenac sodium


Diclofenac Na retard CF 75 mg, tabletten met gereguleerde afgifte


75 mg


Modified-release tablet


Oral use




The Netherlands







Centrafarm B.V.




Nieuwe Donk 3




4879 AC Etten Leur




The Netherlands






Diclofenac sodium


Diclofenac Na retard CF 100 mg, tabletten met gereguleerde afgifte


100 mg


Modified-release tablet


Oral use




The Netherlands







Disphar International B.V.




Winkelskamp 6




7255 PZ Hengelo




The Netherlands






Diclofenac sodium


Diclofenacnatrium Disphar EC 25, maagsapresistente tabletten 25 mg


25 mg


Gastro-resistant tablet


Oral use




The Netherlands







Disphar International B.V.




Winkelskamp 6




7255 PZ Hengelo




The Netherlands






Diclofenac sodium


Diclofenacnatrium Disphar EC 50, maagsapresistente tabletten 50 mg


50 mg


Gastro-resistant tablet


Oral use




The Netherlands







Disphar International B.V.




Winkelskamp 6




7255 PZ Hengelo




The Netherlands






Diclofenac sodium


Diclofenacnatrium Disphar Retard 75, tabletten met gereguleerde afgifte 75 mg


75 mg


Modified-release tablet


Oral use




The Netherlands







Disphar International B.V.




Winkelskamp 6




7255 PZ Hengelo




The Netherlands






Diclofenac sodium


Diclofenacnatrium Disphar Retard 100, tabletten met gereguleerde afgifte 100 mg


100 mg


Modified-release tablet


Oral use




The Netherlands







Disphar International B.V.




Winkelskamp 6




7255 PZ Hengelo




The Netherlands






Diclofenac sodium


Diclofenacnatrium Disphar 25, zetpillen 25 mg


25 mg


Suppository


Rectal use




The Netherlands







Disphar International B.V.




Winkelskamp 6




7255 PZ Hengelo




The Netherlands






Diclofenac sodium


Diclofenacnatrium Disphar 50, zetpillen 50 mg


50 mg


Suppository


Rectal use




The Netherlands







Disphar International B.V.




Winkelskamp 6




7255 PZ Hengelo




The Netherlands






Diclofenac sodium


Diclofenacnatrium Disphar 100, zetpillen 100 mg


100 mg


Suppository


Rectal use




The Netherlands







Manston Pharma Limited




3 Montpelier Avenue, Bexley




DA5 3AP Kent




United Kingdom






Diclofenac sodium


Diclofenacnatrium Manston 25 mg, maagsapresistente tabletten


25 mg


Gastro-resistant tablet


Oral use




The Netherlands







Manston Pharma Limited




3 Montpelier Avenue, Bexley




DA5 3AP Kent




United Kingdom






Diclofenac sodium


Diclofenacnatrium Manston 50 mg, maagsapresistente tabletten


50 mg


Gastro-resistant tablet


Oral use




The Netherlands







Manston Pharma Limited




3 Montpelier Avenue, Bexley




DA5 3AP Kent




United Kingdom






Diclofenac sodium


Diclofenacnatrium retard Manston 100 mg, maagsapresistente tabletten


100 mg


Gastro-resistant tablet


Oral use




The Netherlands







Marel B.V.




Archimedesweg 2




2333 CN Leiden




The Netherlands






Diclofenac potassium


Kruidvat Diclofenac kalium 12,5 mg, filmomhulde tabletten


12,5 mg


Film-coated tablet


Oral use




The Netherlands







Mylan B.V.




Dieselweg 25




3752 LB Bunschoten




The Netherlands






Diclofenac sodium


Diclofenacnatrium 50 mg, zetpillen


50 mg


Suppository


Rectal use




The Netherlands







Mylan B.V.




Dieselweg 25




3752 LB Bunschoten




The Netherlands






Diclofenac sodium


Diclofenacnatrium 100 mg, zetpillen


100 mg


Suppository


Rectal use




The Netherlands







Novartis Consumer Health B.V.




Claudius Prinselaan 142




4818 CP Breda




The Netherlands






Diclofenac potassium


Voltaren K 12,5 mg, filmomhulde tabletten


12,5 mg


Film-coated tablet


Oral use




The Netherlands







Novartis Consumer Health B.V.




Claudius Prinselaan 142




4818 CP Breda




The Netherlands






Diclofenac potassium


Voltaren K 25 mg, omhulde tabletten


25 mg


Coated tablet


Oral use




The Netherlands







Novartis Consumer Health B.V.




Claudius Prinselaan 142




4818 CP Breda




The Netherlands






Diclofenac potassium


Otriflu, omhulde tabletten 12,5 mg


12,5 mg


Coated tablet


Oral use




The Netherlands







Novartis Pharma B.V.




Raapopseweg 1




6824 DP Arnhem




The Netherlands






Diclofenac sodium


Voltaren 25 mg, maagsapresistente tabletten


25 mg


Gastro-resistant tablet


Oral use




The Netherlands







Novartis Pharma B.V.




Raapopseweg 1




6824 DP Arnhem




The Netherlands






Diclofenac sodium


Voltaren 75 mg/3 ml, oplossing voor injectie 25 mg/ml


25 mg/ml


Solution for injection


Intramuscular use, Intravenous use




The Netherlands







Novartis Pharma B.V.




Raapopseweg 1




6824 DP Arnhem




The Netherlands






Diclofenac potassium


Cataflam 50, omhulde tabletten 50 mg


50 mg


Coated tablet


Oral use




The Netherlands







Novartis Pharma B.V.




Raapopseweg 1




6824 DP Arnhem




The Netherlands






Diclofenac sodium


Voltaren Retard 75 mg, tabletten met verlengde afgifte


75 mg


Prolonged-release tablet


Oral use




The Netherlands







Pfizer B.V.




Rivium Westlaan 142




2909 LD Capelle aan den IJssel




The Netherlands






Diclofenac sodium
Misoprostol


Arthrotec 50, tabletten


50 mg


Modified-release tablet


Oral use




The Netherlands







Pfizer B.V.




Rivium Westlaan 142




2909 LD Capelle aan den IJssel




The Netherlands






Diclofenac sodium
Misoprostol


Arthrotec 75, tabletten 75 mg


75 mg


Modified-release tablet


Oral use




The Netherlands







Pharmachemie B.V.




Swensweg 5




2031 GA Haarlem




The Netherlands






Diclofenac sodium


Diclofenacnatrium 25 PCH, maagsapresistente tabletten


25 mg


Gastro-resistant tablet


Oral use




The Netherlands







Pharmachemie B.V.




Swensweg 5




2031 GA Haarlem




The Netherlands






Diclofenac sodium


Diclofenacnatrium 50 PCH, maagsapresistente tabletten


50 mg


Gastro-resistant tablet


Oral use




The Netherlands







Pharmachemie B.V.




Swensweg 5




2031 GA Haarlem




The Netherlands






Diclofenac sodium


Diclofenacnatrium 25 PCH, zetpillen 25 mg


25 mg


Suppository


Rectal use




The Netherlands







Pharmachemie B.V.




Swensweg 5




2031 GA Haarlem




The Netherlands






Diclofenac sodium


Diclofenacnatrium 50 PCH, zetpillen 50 mg


50 mg


Suppository


Rectal use




The Netherlands







Pharmachemie B.V.




Swensweg 5




2031 GA Haarlem




The Netherlands






Diclofenac sodium


Diclofenacnatrium 100 PCH, zetpillen 100 mg


100 mg


Suppository


Rectal use




The Netherlands







Pharmachemie B.V.




Swensweg 5




2031 GA Haarlem




The Netherlands






Diclofenac sodium


Diclofenac Na retard 75 PCH, tabletten met gereguleerde afgifte 75 mg


75 mg


Modified-release tablet


Oral use




The Netherlands







Pharmachemie B.V.




Swensweg 5




2031 GA Haarlem




The Netherlands






Diclofenac sodium


Diclofenac Na Retard 100 PCH tabletten met gereguleerde afgifte 100 mg


100 mg


Modified-release tablet


Oral use




The Netherlands







Pharmacin B.V.




Molenvliet 103




3335 LH Zwijndrecht




The Netherlands






Diclofenac sodium


Diclofenacnatrium Pharmacin 25 mg, maagsapresistente tabletten


25 mg


Gastro-resistant tablet


Oral use




The Netherlands







Pharmacin B.V.




Molenvliet 103




3335 LH Zwijndrecht




The Netherlands






Diclofenac sodium


Diclofenacnatrium Pharmacin 50 mg, maagsapresistente tabletten


50 mg


Gastro-resistant tablet


Oral use




The Netherlands







Pharmacin B.V.




Molenvliet 103




3335 LH Zwijndrecht




The Netherlands






Diclofenac sodium


Diclofenac Na Pharmacin 100 mg, tabletten met gereguleerde afgifte


100 mg


Modified-release tablet


Oral use




The Netherlands







ratiopharm Nederland B.V.




Florapark 4




2012 HK Haarlem




The Netherlands






Diclofenac sodium


Diclofenac Na ratiopharm retard 75 mg, tabletten met gereguleerde afgifte


75 mg


Modified-release tablet


Oral use




The Netherlands







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




The Netherlands






Diclofenac sodium


Diclofenacnatrium Sandoz retard 75, tabletten met gereguleerde afgite 75 mg


75 mg


Modified-release tablet


Oral use




The Netherlands







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




The Netherlands






Diclofenac sodium


Diclofenacnatrium Sandoz retard 100, tabletten met gereguleerde afgite 100 mg


100 mg


Modified-release tablet


Oral use




The Netherlands







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




The Netherlands






Diclofenac sodium


Diclofenacnatrium Sandoz 25, maagsapresistente tabletten 25 mg


25 mg


Gastro-resistant tablet


Oral use




The Netherlands







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




The Netherlands






Diclofenac sodium


Diclofenacnatrium Sandoz 50, maagsapresistente tabletten 50 mg


50 mg


Gastro-resistant tablet


Oral use




The Netherlands







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




The Netherlands






Diclofenac sodium


Diclofenacnatrium Sandoz injectie 75 mg/3 ml, oplossing voor injectie 25 mg/ml


25 mg/ml


Solution for injection


Intramuscular use, Intravenous use




The Netherlands







Teva Nederland B.V.




Swensweg 5




2031 GA Haarlem




The Netherlands






Diclofenac sodium


Diclofenacnatrium 25 mg Teva, zetpilen


25 mg


Suppository


Rectal use




The Netherlands







Teva Nederland B.V.




Swensweg 5




2031 GA Haarlem




The Netherlands






Diclofenac sodium


Diclofenacnatrium 50 mg Teva, zetpilen


50 mg


Suppository


Rectal use




The Netherlands







Teva Nederland B.V.




Swensweg 5




2031 GA Haarlem




The Netherlands






Diclofenac sodium


Diclofenacnatrium 100 mg Teva, zetpilen


100 mg


Suppository


Rectal use




The Netherlands







Wise Pharmaceuticals Ltd.




Hamwells Business Park Unit No. 7, Hardicker Street




M19 2RB Manchester




United Kingdom






Diclofenac sodium


Diclofenacnatrium 25 mg, maagsapresistente tabletten


25 mg


Gastro-resistant tablet


Oral use




The Netherlands







Wise Pharmaceuticals Ltd.




Hamwells Business Park Unit No. 7, Hardicker Street




M19 2RB Manchester




United Kingdom






Diclofenac sodium


Diclofenacnatrium 50 mg, maagsapresistente tabletten


50 mg


Gastro-resistant tablet


Oral use




United Kingdom







Novartis Consumer Health UK Limited




Park View, Riverside Way




Watchmoor Park, Camberley




Surrey GU15 3YL




United Kingdom






Diclofenac potassium


Voltarol Pain-Eze Extra Strength Tablets


25 mg


Coated tablet


Oral use




United Kingdom







Novartis Consumer Health UK Limited




Park View, Riverside Way




Watchmoor Park, Camberley




Surrey GU15 3YL




United Kingdom






Diclofenac potassium


Voltarol Pain-Eze Tablets


12,5 mg


Coated tablet


Oral use




United Kingdom







Pfizer Limited




Ramsgate Road




Sandwich




Kent CT13 9NJ




United Kingdom






Diclofenac sodium


Arthrotec 50 Modified-Release tablets


50 mg


Modified-release tablet


Oral use




United Kingdom







Pfizer Limited




Ramsgate Road




Sandwich




Kent CT13 9NJ




United Kingdom






Diclofenac sodium


Arthrotec 75 Modified-Release tablets


75 mg


Modified-release tablet


Oral use




United Kingdom







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


Voltarol Injection 75 mg/3 ml


75 mg


Solution for Injection


Intramuscular use, Intravenous use




United Kingdom







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac free acid


Voltarol Dispersible Tablets 50 mg


46,5 mg


Tablet for oral solution


Oral use




United Kingdom







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


Voltarol Retard Tablets 100 mg


100 mg


Modified-release tablet


Oral use




United Kingdom







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


Voltarol SR Tablets


75 mg


Modified-release tablet


Oral use




United Kingdom







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


Voltarol Suppositories 12,5 mg


12,5 mg


Suppository


Rectal use




United Kingdom







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


Voltarol Suppositories 25 mg


25 mg


Suppository


Rectal use




United Kingdom







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


Voltarol Suppositories 50 mg


50 mg


Suppository


Rectal use




United Kingdom







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


Voltarol Suppositories 100 mg


100 mg


Suppository


Rectal use




United Kingdom







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


Voltarol Tablets 25 mg


25 mg


Gastro-resistant tablet


Oral use




United Kingdom







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


Voltarol Tablets 50 mg


50 mg


Gastro-resistant tablet


Oral use




United Kingdom







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


Voltarol Rapid Tablets 25 mg


25 mg


Coated tablet


Oral use




United Kingdom







Novartis Pharmaceuticals UK ltd.




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Diclofenac sodium


Voltarol Rapid Tablets 50 mg


50 mg


Coated tablet


Oral use




United Kingdom







Actavis UK Limited




Whiddon Valley




Barnstaple




North Devon EX32 8NS




United Kingdom






Diclofenac sodium


Flamatak MR Tablets 75 mg


75 mg


Modified-release tablet


Oral use




United Kingdom







Teva UK Limited




Brampton Road




Hampden Park




Eastbourne




E Sussex BN22 9AG




United Kingdom






Diclofenac sodium


Teva UK Diclofenac Sodium Tablets 25 mg


25 mg


Gastro-resistant tablet


Oral use




United Kingdom







Teva UK Limited




Brampton Road




Hampden Park




Eastbourne




E Sussex BN22 9AG




United Kingdom






Diclofenac sodium


Teva UK Diclofenac Sodium Tablets 50 mg


50 mg


Gastro-resistant tablet


Oral use




United Kingdom







Chatfield Pharmaceuticals Limited




Kramer Mews




London SW5 9JL




United Kingdom






Diclofenac sodium


Chatfield Pharms Diclofenac Sodium Tablets 25 mg


25 mg


Gastro-resistant tablet


Oral use




United Kingdom







Mercury Pharma International Limited




4045 Kingswood Road




City West Business Park




Co Dublin, Ireland






Diclofenac sodium


Antigen Diclofenac Sodium Injection 2,5 % w/v


75 mg


Solution for injection


Intramuscular use




United Kingdom







Sandoz Limited




Frimley Business Park




Frimley




Camberley, GUI16 7SR




United Kingdom






Diclofenac sodium


Sandoz Ltd Rhumalgan CR75 Modified Release Tablets 75 mg


75 mg


Modified-release tablet


Oral use




United Kingdom







Sandoz Limited




Frimley Business Park




Frimley




Camberley, GUI16 7SR




United Kingdom






Diclofenac sodium


Sandoz Ltd Rhumalgan CR100 Modified Release Tablet 100 mg


100 mg


Modified-release tablet


Oral use




United Kingdom







Sandoz Limited




Frimley Business Park




Frimley




Camberley, GUI16 7SR




United Kingdom






Diclofenac sodium


Lagap Pharms Diclofenac Tablets 25 mg


25 mg


Gastro-resistant tablet


Oral use




United Kingdom







Sandoz Limited




Frimley Business Park




Frimley




Camberley, GUI16 7SR




United Kingdom






Diclofenac sodium


Lagap Pharms Diclofenac Tablets 50 mg


50 mg


Gastro-resistant tablet


Oral use




United Kingdom







Sandoz Limited




Frimley Business Park




Frimley




Camberley, GUI16 7SR




United Kingdom






Diclofenac sodium


Sandoz Ltd Diclovol SR Modified Release Tablet 75 mg


75 mg


Modified-release tablet


Oral use




United Kingdom







Sandoz Limited




Frimley Business Park




Frimley




Camberley, GUI16 7SR




United Kingdom






Diclofenac sodium


Sandoz Ltd Rhumalgan SR Modified Release Capsules 75 mg


75 mg


Modified-Release Capsule, Hard


Oral use




United Kingdom







Sandoz Limited




Frimley Business Park




Frimley




Camberley, GUI16 7SR




United Kingdom






Diclofenac sodium


Sandoz Ltd Rhumalgan XL Modified Release Capsules 100 mg


100 mg


Modified-Release Capsule, Hard


Oral use




United Kingdom







Generics (UK) Limited




Station Close




Potters Bar




Hertfordshire EN6 1TL




United Kingdom






Diclofenac sodium


Generics UK Diclofenac Sodium Tablets 25 mg


25 mg


Gastro-resistant tablet


Oral use




United Kingdom







Generics (UK) Limited




Station Close




Potters Bar




Hertfordshire EN6 1TL




United Kingdom






Diclofenac sodium


Generics UK Diclofenac Sodium Tablets 50 mg


50 mg


Gastro-resistant tablet


Oral use




United Kingdom







Waymade Plc




Regency House




Miles Gray Road




Basildon, Essex SS14 3RF




United Kingdom






Diclofenac sodium


Rheumatac Retard Tablets 75 mg


75 mg


Modified-release tablet


Oral use




United Kingdom







Daichi-Sankyo UK Limited




Chiltern Place




Chalfont Park




Gerrards Cross




Buckinghamshire SL9 0BG




United Kingdom






Diclofenac sodium


Motifene Capsules 75 mg


75 mg


Modified-release capsule


Oral use




United Kingdom







Chiesi Limited




Cheadle Royal Business Park




Highfield, Cheadle




Cheshire SK8 3GY




United Kingdom






Diclofenac sodium


Volsaid Retard Tablets 75 mg


75 mg


Modified-release tablet


Oral use




United Kingdom







Chiesi Limited




Cheadle Royal Business Park




Highfield, Cheadle




Cheshire SK8 3GY




United Kingdom






Diclofenac sodium


Volsaid Retard Tablets 100 mg


100 mg


Modified-release tablet


Oral use




United Kingdom







Mercury Pharma Group Limited




No. 1 Croydon




12-16 Addiscombe Road




Croydon, Surrey CR0 0XT




United Kingdom






Diclofenac sodium


Econac Suppositories 100 mg


100 mg


Suppository


Rectal use




United Kingdom







Mercury Pharma Group Limited




No. 1 Croydon




12-16 Addiscombe Road




Croydon, Surrey CR0 0XT




United Kingdom






Diclofenac sodium


Econac Injection 75 mg/3 ml


75 mg


Solution for injection


Intramuscular use




United Kingdom







Mercury Pharma Group Limited




No. 1 Croydon




12-16 Addiscombe Road




Croydon, Surrey CR0 0XT




United Kingdom






Diclofenac sodium


Mercury Pharms Diclofenac Solution for Injection 75 mg/3 ml


75 mg


Solution for injection


Intramuscular use, Intravenous use




United Kingdom







Mercury Pharma Group Limited




No. 1 Croydon




12-16 Addiscombe Road




Croydon, Surrey CR0 0XT




United Kingdom






Diclofenac sodium


Mercury Pharms Econac SR Prolonged Release Tablet 75 mg


75 mg


Prolonged-release tablet


Oral use




United Kingdom







Mercury Pharma Group Limited




No. 1 Croydon




12-16 Addiscombe Road




Croydon, Surrey CR0 0XT




United Kingdom






Diclofenac sodium


Mercury Pharms Econac XL Prolonged Release Tablet 100 mg


100 mg


Prolonged-release tablet


Oral use




United Kingdom







Mercury Pharma Group Limited




No. 1 Croydon




12-16 Addiscombe Road




Croydon, Surrey CR0 0XT




United Kingdom






Diclofenac sodium


Mercury Pharms Diclofenac Sodium Tablets 25 mg


25 mg


Tablet


Oral use




United Kingdom







Mercury Pharma Group Limited




No. 1 Croydon




12-16 Addiscombe Road




Croydon, Surrey CR0 0XT




United Kingdom






Diclofenac sodium


Mercury Pharms Diclofenac Sodium Tablets 75 mg


50 mg


Tablet


Oral use




United Kingdom







Co-Pharma Limited




Unit 4, Metro Centre




Tolpits Lane, Watford




Hertfordshire WD18 9SS




United Kingdom






Diclofenac sodium


Diclo-XL 100


100 mg


Modified-release tablet


Oral use




United Kingdom







Co-Pharma Limited




Unit 4, Metro Centre




Tolpits Lane, Watford




Hertfordshire WD18 9SS




United Kingdom






Diclofenac sodium


Diclo-SR 75


75 mg


Modified-release tablet


Oral use




United Kingdom







Dexcel Pharma Limited




7 Sopwith Way




Drayton Fields




Industrial Estate, Daventry




Northamptonshire NN11 8PB




United Kingdom






Diclofenac sodium


Dexcel-Pharma Dicloflex Retard Prolonged Release Tablet 100 mg


100 mg


Modified-release tablet


Oral use




United Kingdom







Dexcel Pharma Limited




7 Sopwith Way




Drayton Fields




Industrial Estate, Daventry




Northamptonshire NN11 8PB




United Kingdom






Diclofenac sodium


Dexcel-Pharma Dicloflex SR Prolonged Release Tablet 75 mg


75 mg


Modified-release tablet


Oral use




United Kingdom







Dexcel Pharma Limited




7 Sopwith Way




Drayton Fields




Industrial Estate, Daventry




Northamptonshire NN11 8PB




United Kingdom






Diclofenac sodium


Dexcel-Pharma Diclofenac Sodium Tablets 25 mg


25 mg


Gastro-resistant tablet


Oral use




United Kingdom







Dexcel Pharma Limited




7 Sopwith Way




Drayton Fields




Industrial Estate, Daventry




Northamptonshire NN11 8PB




United Kingdom






Diclofenac sodium


Dexcel-Pharma Diclofenac Sodium Tablets 75 mg


75 mg


Gastro-resistant tablet


Oral use




United Kingdom







Bristol Laboratories Limited




Unit 3, Canal side




Northbridge Road, Berkhamsted




Hertfordshire HP4 1EG




United Kingdom






Diclofenac sodium


Volraman 25 mg Gastro-resistant tablets


25 mg


Gastro-resistant tablet


Oral use




United Kingdom







Bristol Laboratories Limited




Unit 3, Canal side




Northbridge Road, Berkhamsted




Hertfordshire HP4 1EG




United Kingdom






Diclofenac sodium


Volraman 50 mg Gastro-resistant tablets


50 mg


Gastro-resistant tablet


Oral use




United Kingdom







Focus Pharmaceuticals Limited




Unit 5, Faraday court




First Avenue, Centrum 100




Burton upon trent




Staffordshire, DE14 2WX




United Kingdom






Diclofenac potassium


Adacium Rapid 50 mg Tablets


50 mg


Film-coated tablet


Oral use




United Kingdom







Morningside Healthcare Limited




115 Narborough Road




Leicester, LE3 0PA




United Kingdom






Diclofenac sodium
Misoprostol


Misofen 50 mg/200 mcg modified released tablets


50 mg
0,2 mg


Modified-release tablet


Oral use




United Kingdom







Morningside Healthcare Limited




115 Narborough Road




Leicester, LE3 0PA




United Kingdom






Diclofenac sodium
Misoprostol


Misofen 75 mg/200 mcg modified released tablets


75 mg
0,2 mg


Modified-release tablet


Oral use




United Kingdom







Crescent Pharma Limited




Unit 3&4




Quidhampton Business Units




Polhampton Lane, Overton




Hampshire, RG25 3ED




United Kingdom






Diclofenac


Crescent Pharma Diclofenac Tablets BP 25 mg


25 mg


Gastro-resistant tablet


Oral use




United Kingdom







Crescent Pharma Limited




Unit 3&4




Quidhampton Business Units




Polhampton Lane, Overton




Hampshire, RG25 3ED




United Kingdom






Diclofenac


Crescent Pharma Diclofenac Tablets BP 50 mg


50 mg


Gastro-resistant tablet


Oral use




United Kingdom







Therabel pharma UK Limited




Compass House, vision Park




Chivers, Histon




Cambridge CB24 9AD




United Kingdom






Diclofenac sodium


Dyloject 75 mg/2 ml solution for injection


75 mg/2 ml


solution for injection


Intramuscular use, Intravenous use




United Kingdom







Galen Limited




Seagoe Industrial Estate




Craigavon




Armagh BT 63 5AU




United Kingdom






Diclofenac sodium


Diclomax SR


75 mg


Modified-release capsule


Oral use




United Kingdom







Galen Limited




Seagoe Industrial Estate




Craigavon




Armagh BT 63 5AU




United Kingdom






Diclofenac sodium


Diclomax Retard


100 mg


Modified-release capsule


Oral use




United Kingdom







Actavis Group PTC ehf




Reykjavikurvegi 76-78




IS-220 Hafnarfjördur




Iceæand






Diclofenac potassium


Doble action pain relief


12,5 mg


Tablet


Oral use




United Kingdom







Actavis Group PTC ehf




Reykjavikurvegi 76-78




IS-220 Hafnarfjördur




Iceæand






Diclofenac potassium


Diclofenac potassium 12,5 mg Tablets


12,5 mg


Tablet


Oral use




United Kingdom







Actavis Group PTC ehf




Reykjavikurvegi 76-78




IS-220 Hafnarfjördur




Iceæand






Diclofenac potassium


Diclofenac potassium 25 mg Tablets


25 mg


Film-coated tablet


Oral use




United Kingdom







Actavis Group PTC ehf




Reykjavikurvegi 76-78




IS-220 Hafnarfjördur




Iceæand






Diclofenac potassium


Diclofenac potassium 50 mg Tablets


50 mg


Film-coated tablet


Oral use




United Kingdom







Chelonia Healthcare Limited




Boumpoulinas 11




3rd, Nicosia




CY-1060




Cyprus






Diclofenac sodium


Diclofenac sodium 25 mg Tablets


25 mg


Gastro-resistant tablet


Oral use




United Kingdom







RI Pharma Limited




First floor, 6 St John's Court




Upper Fforest Way




Swansea Enterprise Park




Swansea SA6 8QQ




United Kingdom






Diclofenac sodium


Slofenac 75 mg SR


75 mg


Modified-release tablet


Oral use




United Kingdom







RI Pharma Limited




First floor, 6 St John's Court




Upper Fforest Way




Swansea Enterprise Park




Swansea SA6 8QQ




United Kingdom






Diclofenac sodium


Slofenac 100 mg SR


100 mg


Modified-release tablet


Oral use




United Kingdom







Ennogen Pharma Limited




Unit G4, Riverside Way




Dartford, DA1 5BS




United Kingdom






Diclofenac sodium


Enstar SR 75 mg Tablets


75 mg


Prolonged-release tablet


Oral use




United Kingdom







Ennogen Pharma Limited




Unit G4, Riverside Way




Dartford, DA1 5BS




United Kingdom






Diclofenac sodium


Enstar XL 100 mg Tablets


100 mg


Modified-release tablet


Oral use




United Kingdom







Aptil Pharma limited




9th Floor




CP House




97-107 Uxbridge Road




London W5 5TL




United Kingdom






Diclofenac potassium


Diclofenac potassium 12,5 mg Tablets


12,5 mg


Film-coated tablet


Oral use




United Kingdom







Aptil Pharma limited




9th Floor




CP House




97-107 Uxbridge Road




London W5 5TL




United Kingdom






Diclofenac potassium


Diclofenac potassium 25 mg Tablets


25 mg


Film-coated tablet


Oral use




United Kingdom







Aptil Pharma limited




9th Floor




CP House




97-107 Uxbridge Road




London W5 5TL




United Kingdom






Diclofenac potassium


Diclofenac potassium 50 mg Tablets


50 mg


Film-coated tablet


Oral use







ANNEX X

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES











Member State (in EEA)


Marketing Authorisaton Holder


(Invented) Name


Strength


Pharmaceutical form


Route of administration




Austria







WABOSAN




Arzneimittelvertriebs




GmbH, Anton Anderer




Platz 6/1, A-1210 Vienna




Austria






Ergomed retard - Kapseln


2.5 mg (1:1:1)


prolonged-release capsule, soft


oral use




Austria







WABOSAN




Arzneimittelvertriebs




GmbH, Anton Anderer




Platz 6/1, A-1210 Vienna




Austria






Ergomed - Tropfen


1 mg/ml (1:1:1)


oral drops, solution


oral use




Czech Republic







TEVA Czech Industries s.r.o.




Ostravská 29




747 70 Opava-Komárov




Czech Republic






ERSILAN


1mg/ml


Oral drops, solution


oral use




France







PIERRE FABRE MEDICAMENT




45, place Abel Gance




92100 Boulogne




Billancourt




France






ISKEDYL FORT, comprimé


2.40 mg/19.20 mg


tablet


oral use




France







PIERRE FABRE MEDICAMENT




45, place Abel Gance




92100 Boulogne




Billancourt




France






ISKEDYL, comprimé


0.60 mg / 4.80 mg


tablet


oral use




France







PIERRE FABRE MEDICAMENT




45, place Abel Gance




92100 Boulogne




Billancourt




France






ISKEDYL, solution buvable en flacon


0.10 g / 0.80 g


oral solution


oral use




France







PIERRE FABRE MEDICAMENT




45, place Abel Gance




92100 Boulogne




Billancourt




France






ISKEDYL, solution injectable en ampoule


0.3125 mg /6.25 mg


solution for injection


IV/IM




Greece







PHARMANEL PHARMACEUTICALS S.A.




MARATHONOS 106,




GERAKAS 15344




Greece






DIERTINA


3mg/cap


capsules, soft


oral use




Greece







PHARMANEL PHARMACEUTICALS S.A.




MARATHONOS 106,




GERAKAS 15344




Greece






DIERTINA


6MG/SINGLE DOSE


powder for oral solution for single dose


oral use




Greece







PHARMANEL PHARMACEUTICALS S.A.




MARATHONOS 106,




GERAKAS 15344




Greece






DIERTINA


6MG/TAB


tablet


oral use




Greece







VOCATE PHARMAKEFTIKI A.E.




GOUNARI 150,




GLYFADA, 16674




Greece






ERGOFIL


6MG/TAB


tablet


oral use




Greece







GENEPHARM A.E.




18TH Km MARATHONOS




AVENUE, PALLINI,




ATTIKIS, 15351




Greece






MEMOTIL / GENEPHARM


6MG/TAB


tablet


oral use




Greece







ANTOR LTD




P. MAVROMIHALI 1




VRILISSIA 15235




Greece






THRIOLAN


6MG/TAB


tablet


oral use




Greece







LEOVAN, M. LEWN & SIA EE




ARGONAFTWN 22,




ARGYROUPOLI, 16452




Greece






FENITINA


6MG/TAB


tablet


oral use




Greece







PHARMACEUTICAL INDUSTRY PROEL EPAM.




G. KORONIS




DILOU 9, PERISTERI,




ATTIKIS, 12134




Greece






BEYTINA


6MG/TAB


tablet


oral use




Greece







FINIXFARM EPE




DERVENAKION 38 & SAHINI,




GERAKAS, 15344




Greece






CRISTIL


6MG/TAB


tablet


oral use




Greece







S.J.A. PHARM O.E.




ARKOLEON 11, KATO




PATISSIA, 10445




Greece






AGIOBITA


6MG/TAB


tablet


oral use




Luxembourg







Pierre Fabre Médicaments




45, PLACE ABEL GANCE




F 92654 BOULOGNE




CEDEX




France






Iskedyl Fort


2.40 mg/19.20 mg


tablets


oral use




Portugal







Daiichi Sankyo




Portugal,Lda. PRT




Lagoas Park, Edifício 11




2740-270 Porto Salvo




Portugal






Diertina


3 mg


Capsule hard


oral use




Spain







LABORATORIOS DAVUR, S.L.




Teide, 4 - planta baja Polígono Empresarial La Marina




28703 San Sebastian de los Reyes (Madrid)




Spain






ERGODAVUR GOTAS


1 mg (monodose suchet)


oral drops, solution


oral use




Spain







TORA LABORATORIES




S.L. Ferraz 80, 5o





28008 Madrid




Spain






DIERTINE FORTE


2 mg/ ml


oral drops, solution


oral use







ANNEX XI

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES











Member State
(in EEA)


Marketing Authorisaton Holder


(Invented) Name


Strength


Pharmaceutical form


Route of administration




France







CHIESI




11, avenue Dubonnet




92400 Courbevoie




France






VASOBRAL, comprimé sécable


4 mg/40 mg


tablet


oral use




France







CHIESI




11, avenue Dubonnet




92400 Courbevoie




France






VASOBRAL, solution buvable en flacon


0,10 g/1 g per 100 ml


oral solution


oral use







ANNEX XII

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES











Member State (in EEA)


Marketing Authorisaton Holder


(Invented) Name


Strength


Pharmaceutical form


Route of administration




Austria







Kwizda Pharma GmbH




Effingergasse 21




1160 Vienna




Austria






Ergotop 10 mg - Tabletten


10 mg


tablet


oral use




Austria







Kwizda Pharma GmbH




Effingergasse 21




1160 Vienna




Austria






Ergotop 20 mg - Filmtabletten


20 mg


film-coated tablet


oral use




Austria







Kwizda Pharma GmbH




Effingergasse 21




1160 Vienna




Austria






Ergotop 30 mg - Filmtabletten


30 mg


film-coated tablet


oral use




Austria







Rösch & Handel




Scheringgasse 2/Objekt 2




1140 Vienna




Austria






Nicergin - Filmtabletten


30 mg


film-coated tablet


oral use




Austria







Pfizer Corporation Austria GmbH




Floridsdorfer Hauptstraße 1




1210 Vienna




Austria






Sermion 30 mg - Filmtabletten


30 mg


film-coated tablet


oral use




Bulgaria







Pfizer Enterprises SARL




Avenue J.F.Kennedy 51




L-1855




Luxembourg






Sermion


4 mg/4 ml


powder and solvent for solution for injection


intramuscular and intravenous use




Bulgaria







Pfizer Enterprises SARL




Avenue J.F.Kennedy 51




L-1855




Luxembourg






Sermion


30 mg


film-coated tablets


oral use




Czech Republic







Pfizer, spol. s r.o., Praha




Stroupežnického 17




150 00 Prague 5




Czech Republic






SERMION


30 mg


Film-coated tablet


oral use




France







SANOFI AVENTIS France




1-13, boulevard Romain Rolland




75014 Paris




France






SERMION 10 mg, gélule


10 mg


capsule, hard


oral use




France







SANOFI AVENTIS France




1-13, boulevard Romain Rolland




75014 Paris




France






SERMION 5 mg, gélule


5 mg


capsule, hard


oral use




France







SANOFI AVENTIS France




1-13, boulevard Romain Rolland




75014 Paris




France






SERMION 5 mg, poudre pour solution pour perfusion


5 mg


powder for solution for infusion


intravenous use




France







BIOGARAN




15, boulevard Charles de Gaulle




92700 Colombes




France






NICERGOLINE BIOGARAN 10 mg, gélule


10 mg


capsule, hard


oral use




France







BIOGARAN




15, boulevard Charles de Gaulle




92700 Colombes




France






NICERGOLINE BIOGARAN 5 mg, gélule


5 mg


capsule, hard


oral use




France







EG LABO - LABORATOIRES EUROGENERICS




"Le Quintet" - bâtiment A




12, rue Danjou




92517 Boulogne Billancourt Cedex




France






NICERGOLINE EG 10 mg, gélule


10 mg


capsule, hard


oral use




France







EG LABO - LABORATOIRES EUROGENERICS




"Le Quintet" - bâtiment A




12, rue Danjou




92517 Boulogne Billancourt Cedex




France






NICERGOLINE EG 5 mg, gélule


5 mg


capsule, hard


oral use




France







MYLAN SAS




117, allée des Parcs




69800 Saint-Priest




France






NICERGOLINE MYLAN 10 mg, gélule


10 mg


capsule, hard


oral use




France







MYLAN SAS




117, allée des Parcs




69800 Saint-Priest




France






NICERGOLINE MYLAN 5 mg, gélule


5 mg


capsule, hard


oral use




France







QUALIMED (LYON)




117, allée des Parcs




69800 Saint-Priest




France






NICERGOLINE QUALIMED 10 mg, gélule


10 mg


capsule, hard


oral use




France







QUALIMED (LYON)




117, allée des Parcs




69800 Saint-Priest




France






NICERGOLINE QUALIMED 5 mg, gélule


5 mg


capsule, hard


oral use




France







TEVA SANTE




110, Esplanade du Général de Gaulle




92931 Paris La Défense Cedex




France






NICERGOLINE TEVA 10 mg, gélule


10 mg


capsule, hard


oral use




France







TEVA SANTE




110, Esplanade du Général de Gaulle




92931 Paris La Défense Cedex




France






NICERGOLINE TEVA 5 mg, gélule


5 mg


capsule, hard


oral use




Hungary







Pfizer Kft.




Alkotás u. 53., MOM Park F épület




1123 Budapest




Hungary






SERMION 30 mg filmtabletta


30 mg


film-coated tablet


oral use




Italy







Pfizer Italia srl




Via Isonzo, 71




04100 Latina




Italy






SERMION


10 mg/ml


powder and solvent per oral solution


oral use




Italy







Pfizer Italia srl




Via Isonzo, 71




04100 Latina




Italy






SERMION


5 mg


coated tablet


oral use




Italy







Pfizer Italia srl




Via Isonzo, 71




04100 Latina




Italy






SERMION


10 mg


coated tablet


oral use




Italy







Pfizer Italia srl




Via Isonzo, 71




04100 Latina




Italy






SERMION


30 mg


film coated tablet


oral use




Italy







Pfizer Italia srl




Via Isonzo, 71




04100 Latina




Italy






SERMION


30 mg


soluble tablet


oral use




Italy







Angenerico spa




Via Nocera Umbra,




75 00181 Roma




Italy






NICERGOLINA ANGENERICO


10 mg/ml


powder and solvente per oral solution


oral use




Italy







Angenerico spa




Via Nocera Umbra,




75 00181 Roma




Italy






NICERGOLINA ANGENERICO


30 mg


tablet


oral use




Italy







Sandoz spa




Largo Umberto Boccioni,




1 21040 Origgio - Varese




Italy






NICERGOLINA SANDOZ


30 mg


effervescent tablet


oral use




Italy







Sandoz spa




Largo Umberto Boccioni,




1 21040 Origgio - Varese




Italy






NICERGOLINA SANDOZ


30 mg


tablet


oral use




Italy







EG spa




Via Scarlatti Domenico,




31 20124 Milano




Italy






NICERGOLINA EG


30 mg


tablet


oral use




Latvia







Sandoz d.d.,




Verovškova 57,




1000 Ljubljana,




Slovenia






Nicerium


10 mg


film-coated tablets


oral use




Latvia







Sandoz d.d.,




Verovškova 57,




1000 Ljubljana,




Slovenia






Nicerium


30 mg


capsules, hard


oral use




Latvia







Pfizer Italia S.r.l.,




Via Isonzo 71,




04100 Latina,




Italy






Sermion


5 mg


film-coated tablets


oral use




Latvia







Pfizer Italia S.r.l.,




Via Isonzo 71,




04100 Latina,




Italy






Sermion


10 mg


film-coated tablets


oral use




Lithuania







Pfizer Italia S.r.l.,




Borgo San Michele S.S. 156 Km. 50




Latina (LT),




Italy






Sermion


4 mg


Powder and solvent for solution for injection


intramuscular use intravenous use




Lithuania







Pfizer Italia S.r.l.,




Borgo San Michele S.S. 156 Km. 50




Latina (LT)




Italy






Sermion


5 mg


Coated tablet


oral use




Lithuania







Pfizer Italia S.r.l.,




Borgo San Michele S.S. 156 Km. 50




Latina (LT),




Italy






Sermion


10 mg


Coated tablet


oral use




Lithuania







Pfizer Italia S.r.l.,




Borgo San Michele S.S. 156 Km. 50




Latina (LT),




Italy






Sermion


30 mg


Film-coated tablet


oral use




Lithuania







Sandoz d.d.,




Verovškova 57,




1000 Ljubljana,




Slovenia






Nicerium


30 mg


Capsule, hard


oral use




Lithuania







Sandoz d.d.,




Verovškova 57,




1000 Ljubljana,




Slovenia






Nicerium


10 mg


Film-coated tablet


oral use




Poland







Farmaceutyczna Spółdzielnia Pracy FILOFARM




ul. Pułaskiego 39




85-619 Bydgoszcz




Poland






Nicergolin


10 mg


tablet


oral use




Poland







Pfizer Europe MA EEIG




Ramsgate Road




CT13 9 NJ Kent, Sandwich




United Kingdom






Nicergolin


10 mg


coated tablet


oral use




Poland







Pfizer Italia S.r.l.




Borgo San Michele SS 156 Km 50




Latina




Italy






Nicergolin


4 mg


powder and solvent for solution for injection


intramuscular use intravenous use




Portugal







Laboratórios Pfizer,




Lda. PRT Lagoas Park,




Edifício 10 Porto Salvo




Portugal






Sermion 30


30 mg


Film-coated tablet


oral use




Romania







S.C. LABORMED PHARMA S.A.




Bd. Theodor Pallady nr. 44 B,




sector 3, București,




Romania






NICERGOLINA LPH 5 mg


5 mg


Film – coated tablet


oral use




Romania







S.C. LABORMED PHARMA S.A.




Bd. Theodor Pallady nr. 44 B,




sector 3, București,




Romania






NICERGOLINA LPH 10 mg


10 mg


Film – coated tablet


oral use




Romania







S.C. LABORMED PHARMA S.A.




Bd. Theodor Pallady nr. 44 B,




sector 3, București,




Romania






NICERGOLINA LPH 30 mg


30 mg


Film – coated tablet


oral use




Romania







S.C. SLAVIA PHARM S.R.L.




B-dul Theodor Pallady nr. 44C




Sector 3, București,




Romania






GRALIN 5 mg


5 mg


Film – coated tablet


oral use




Romania







S.C. SLAVIA PHARM S.R.L.




B-dul Theodor Pallady nr. 44C




Sector 3, București,




Romania






GRALIN 10 mg


10 mg


Film – coated tablet


oral use




Romania







S.C. SLAVIA PHARM S.R.L.




B-dul Theodor Pallady nr. 44C




Sector 3, București,




Romania






GRALIN 30 mg


30 mg


Film – coated tablet


oral use




Romania







HEXAL AG




Industriestrasse 25,




D-83607 Holzkirchen,




Germany






NICERIUM® 10


10 mg


Coated tablet


oral use




Romania







Hexal AG,




Industriestrasse 25,




D-83607 Holzkirchen,




Germany






NICERIUM® 15


15 mg


Modified – release capsule, hard


oral use




Romania







HEXAL AG,




Industriestrasse 25,




D-83607 Holzkirchen,




Germany






NICERIUM® 30 UNO


30 mg


Modified – release capsule, hard


oral use




Spain







PFIZER, S.L.




Avenida de Europa,




20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid)




Spain






SERMION 5 mg


5 mg


coated tablet


oral use







ANNEX XIII

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES











Member State
(in EEA)


Marketing Authorisaton Holder


(Invented) Name


Strength


Pharmaceutical form


Route of administration




Austria







Boehringer Ingelheim




RCV GmbH & Co KG,




Dr. Boehringer-Gasse 5-11,




A-1121 Vienna




Austria






Effortil comp. - Tropfen


2 mg/ml, 10 mg/ml


oral drops, solution


oral use




Austria







ratiopharm Arzneimittel




Vertriebs-GmbH,




Albert-Schweitzer-Gasse 3,




A-1140 Vienna




Austria






DHE "ratiopharm" 2,5 mg - Kapseln


2,5 mg


prolonged-release capsule, hard


oral use




Austria







ratiopharm Arzneimittel




Vertriebs-GmbH,




Albert-Schweitzer-Gasse 3,




A-1140 Vienna




Austria






DHE "ratiopharm" 5 mg - Kapseln


5 mg


prolonged-release capsule, hard


oral use




Austria


Amdipharm Ltd.
3, Burlington Road,
Temple Chambers,
Dublin 4
Ireland


Dihydergot 2,5 mg - Tabletten


2,5 mg


tablet


oral use




Austria







WABOSAN




Arzneimittelvertriebs




GmbH, Anton Anderer




Platz 6/1,




A-1210 Vienna




Austria






Ergovasan 2 mg/ml - Tropfen


2 mg/ml


oral drops, solution


oral use




Austria







WABOSAN




Arzneimittelvertriebs




GmbH, Anton Anderer




Platz 6/1,




A-1210 Vienna




Austria






Ergovasan 2,5 mg retard - Kapseln


2,5 mg


prolonged-release capsule, hard


oral use




Austria







WABOSAN




Arzneimittelvertriebs




GmbH, Anton Anderer




Platz 6/1,




A-1210 Vienna




Austria






Ergovasan 5 mg retard - Kapseln


5 mg


prolonged-release capsule, hard


oral use




Belgium







Amdipharm Limited




Burlington Road, 3




Dublin 4




Ireland






Dihydergot Forte


2,5 mg


Tablet


oral use




Belgium







Laboratoires Belges




PHARMACOBEL SA




Avenue de Scheut 46-50




1070 Brussels




Belgium






Dystonal


2,5 mg


Tablet


oral use




Finland







Amdipharm Limited




Temple Chambers




3 Burlington Road




Dublin 4




Ireland






ORSTANORM


2,5 mg


tablet


oral use




France







PIERRE FABRE




MEDICAMENT




45, place Abel Gance




92100 Boulogne




Billancourt




France






IKARAN L.P. 5 mg, comprimé à libération prolongée


5 mg


prolonged-release tablet


oral use




France







PIERRE FABRE




MEDICAMENT




45, place Abel Gance




92100 Boulogne




Billancourt




France






IKARAN, solution buvable en gouttes


0.20 g /100 ml


oral drops, solution


oral use




France







UCB PHARMA




420 Avenue Estienne d'Orves




Défense Ouest




92700 Colombes




France






SEGLOR 2 mg/ml, solution buvable en gouttes


2 mg/ml


oral solution


oral use




France







UCB PHARMA




420 Avenue Estienne d'Orves




Défense Ouest




92700 Colombes




France






SEGLOR 5 mg, gélule


5 mg


hard capsule


oral use




France







UCB PHARMA




420 Avenue Estienne d'Orves




Défense Ouest




92700 Colombes




France






SEGLOR LYOC 5 mg, lyophilisat oral


5 mg


oral lyophilisate


oral use




France







Alfa Wasserman Pharma SAS




67 rue Anatole France,




92300 Levallois Perret




France






TAMIK, capsule


3 mg


soft capsule


oral use




France







AMDIPHARM




Temple Chambers




3, Burlington Road




DUBLIN 4




IRELAND






DIHYDROERGOTAMINE AMDIPHARM 2 mg/ml, solution buvable


2 mg/ml


oral solution


oral use




France







AMDIPHARM




Temple Chambers




3, Burlington Road




DUBLIN 4




Ireland






DIHYDROERGOTAMINE AMDIPHARM 3 mg, comprimé


3 mg


tablet


oral use




Germany







Amdipharm Limited




Temple Chamcers, 3




Burlington Road




IRL-Dublin 4




Ireland






Dihydergot plus Lösung zum Einnehmen


2 mg/ 1 ml
10 mg/ 1 ml


Solution


oral use




Germany







Boehringer Ingelheim Pharma GmbH & Co.KG




Binger Str. 173




D-55216 Ingelheim




Germany






Effortil plus


0.2 g/ 100 ml
1 g/ 100 ml


Solution


oral use




Germany







Amdipharm Limited




Temple Chambers




3 Burlington Road




Dublin 4




Ireland






DET MS Tropflösung


2 mg/ 1 ml


Solution


oral use




Germany







CT Arzneimittel GmbH




Lengeder Str. 42 a




D-13407 Berlin




Germany






Ergotam-CT 2,5mg Retardkapseln


2,5 mg


Prolonged-released capsule


oral use




Germany







CT Arzneimittel GmbH




Lengeder Str. 42 a




D-13407 Berlin




Germany






Ergotam-CT 5,0mg Retardkapseln


5 mg


Prolonged-released capsule


oral use




Germany







UCB Pharma GmbH




Alfred-Nobel-Str. 10




D-40789 Monheim




Germany






Agit depot sanol


5 mg


Prolonged-released capsule, hard


oral use




Germany







Verla-Pharm Arzneimittel GmbH & Co.KG Hauptstr. 98




D-82327 Tutzing




Germany






Verladyn


2 mg/ 1 ml


solution


oral use




Greece







Amdipharm Ltd.




3 Burlington Road,




Temple Chambers,




Dublin 4




Ireland






Dihydergot


2,5 mg


tablet


oral use




Italy







Teofarma srl




Via Fratelli Cervi, 8




27010 Valle Salimbene




Pavia




Italy






DIIDERGOT


2 mg/ml


oral solution


oral use




Italy







Teofarma srl




Via Fratelli Cervi, 8




27010 Valle Salimbene




Pavia




Italy






DIIDERGOT


3 mg


tablet


oral use




Italy







Acarpia - Servicos




Farmaceuticos LDA




Rua dos Murcas, 88




Funchal Madeira -




Portugal






SEGLOR


5 mg


modified-releasecapsule, hard


oral use




Luxembourg







Pierre Fabre




Médicaments




45, PLACE ABEL GANCE




F 92654 BOULOGNE CEDEX




France






Ikaran


0.20 g /100 ml


oral solution


oral use




Luxembourg







Pierre Fabre




Médicaments




45, PLACE ABEL GANCE




F 92654 BOULOGNE CEDEX




France






Ikaran L.P.


5 mg


tablets


oral use




Poland







Farmaceutyczna




Spółdzielnia Pracy




FILOFARM




ul. Pułaskiego 39




85-619 Bydgoszcz




Poland






Dihydroergotaminum Filofarm


2 mg/g


oral solution


oral use




Poland







Farmaceutyczna




Spółdzielnia Pracy




FILOFARM




ul. Pułaskiego 39




85-619 Bydgoszcz




Poland






DHE - tar


1 mg


tablet


oral use




Portugal







Laboratórios Azevedos –




Indústria Farmacêutica,




S.A. PRT




Edifícios Azevedos –




Estrada Nacional 117-2, Alfragide




2614-504 Amadora




Portugal






Seglor Retard


5 mg


Prolonged-release capsule, hard


oral use




Slovenia







LEK farmacevtska




družba d.d.,




Verovskova 57,




SI-1526 Ljubljana,




Slovenia






Ditamin 2,5 mg tablete


2,5 mg


tablet


oral use




Spain







Amdipharm Limited




Temple Chambers




3 Burlington Road




Dublin 4




Ireland






DIHYDERGOT COMPRIMIDOS


1 mg


tablet


oral use




Sweden







Amdipharm Limited




Temple Chambers




3 Burlington Road




Dublin 4




Ireland






Orstanorm


2,5 mg


Tablets


oral use




Sweden







Amdipharm Limited




Temple Chambers




3 Burlington Road




Dublin 4




Ireland






Orstanorm


5 mg


Tablets


oral use