Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2010 to 31 December 2010 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )
Date: 2011-02-25
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, pharmaceutical industry, pharmaceutical legislation








C_2011061EN.01001801.xml










25.2.2011   


EN


Official Journal of the European Union


C 61/18





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2010 to 31 December 2010

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

2011/C 61/02
—   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




13.12.2010


Lipitor and associated names


See Annex I


See Annex I


14.12.2010




3.12.2010


Prevora


See Annex II


See Annex II


6.12.2010




29.11.2010


Leflunomide ratiopharm







Ratiopharm GmbH,




Graf-Arco-Straße




3, D-89079 Ulm,




Deutschland






These Decisions are addressed to the Member States


1.12.2010




13.12.2010


Revlimid







Celgene Europe Limited,




Riverside House,




Riverside Walk, Windsor,




Berkshire SL4 1NA,




United Kingdom






These Decisions are addressed to the Member States


14.12.2010







—   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




29.11.2010


Ketoprofen containing topical products


See Annex III


See Annex III


1.12.2010






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX I

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











Member State EU/EEA


Marketing Authorisation Holder


Invented name


Strength


Pharmaceutical Form


Route of administration




Austria







Pfizer Corporation Austria Ges.m.b.H.




Floridsdorfer Hauptstrasse 1




A - 1210 Wien




Austria






Sortis 10 mg - Filmtabletten


10 mg


Film-coated tablet


Oral use




Austria







Pfizer Corporation Austria Ges.m.b.H.




Floridsdorfer Hauptstrasse 1




A - 1210 Wien




Austria






Sortis 20 mg - Filmtabletten


20 mg


Film-coated tablet


Oral use




Austria







Pfizer Corporation Austria Ges.m.b.H.




Floridsdorfer Hauptstrasse 1




A - 1210 Wien




Austria






Sortis 40 mg - Filmtabletten


40 mg


Film-coated tablet


Oral use




Austria







Pfizer Corporation Austria Ges.m.b.H.




Floridsdorfer Hauptstrasse 1




A - 1210 Wien




Austria






Sortis 80 mg - Filmtabletten


80 mg


Film-coated tablet


Oral use




Belgium







Pfizer SA




Boulevard de la Plaine 17




B-1050 Brussels




Belgium






Lipitor


10 mg


Film-coated tablet


Oral use




Belgium







Pfizer SA




Boulevard de la Plaine 17




B-1050 Brussels




Belgium






Lipitor


20 mg


Film-coated tablet


Oral use




Belgium







Pfizer SA




Boulevard de la Plaine 17




B-1050 Brussels




Belgium






Lipitor


40 mg


Film-coated tablet


Oral use




Belgium







Pfizer SA




Boulevard de la Plaine 17




B-1050 Brussels




Belgium






Lipitor


80 mg


Film-coated tablet


Oral use




Bulgaria







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


10 mg


Film-coated tablet


Oral use




Bulgaria







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


20 mg


Film-coated tablet


Oral use




Bulgaria







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


40 mg


Film-coated tablet


Oral use




Bulgaria







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


80 mg


Film-coated tablet


Oral use




Cyprus







Pfizer Hellas A. E.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens




Greece






Lipitor


10 mg


Film-coated tablet


Oral use




Cyprus







Pfizer Hellas A. E.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens




Greece






Lipitor


20 mg


Film-coated tablet


Oral use




Cyprus







Pfizer Hellas A. E.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens




Greece






Lipitor


40 mg


Film-coated tablet


Oral use




Czech Republic







Pfizer. s r.o




Stroupežnického 17




150 00 Prague 5




Czech Republic






Sortis


10 mg


Film-coated tablet


Oral use




Czech Republic







Pfizer. s r.o




Stroupežnického 17




150 00 Prague 5




Czech Republic






Sortis


20 mg


Film-coated tablet


Oral use




Czech Republic







Pfizer. s r.o




Stroupežnického 17




150 00 Prague 5




Czech Republic






Sortis


40 mg


Film-coated tablet


Oral use




Czech Republic







Pfizer. s r.o




Stroupežnického 17




150 00 Prague 5




Czech Republic






Sortis


80 mg


Film-coated tablet


Oral use




Denmark







Pfizer ApS




Lautrupvang 8




2750 Ballerup




Denmark






Zarator


10 mg


Film-coated tablet


Oral use




Denmark







Pfizer ApS




Lautrupvang 8




2750 Ballerup




Denmark






Zarator


20 mg


Film-coated tablet


Oral use




Denmark







Pfizer ApS




Lautrupvang 8




2750 Ballerup




Denmark






Zarator


40 mg


Film-coated tablet


Oral use




Denmark







Pfizer ApS




Lautrupvang 8




2750 Ballerup




Denmark






Zarator


80 mg


Film-coated tablet


Oral use




Estonia







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


10 mg


Film-coated tablet


Oral use




Estonia







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


20 mg


Film-coated tablet


Oral use




Estonia







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


40 mg


Film-coated tablet


Oral use




Estonia







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis 80 mg


80 mg


Film-coated tablet


Oral use




Finland







Pfizer Oy




Tietokuja 4




00330 Helsinki




Finland






Lipitor


10 mg


Film-coated tablet


Oral use




Finland







Pfizer Oy




Tietokuja 4




00330 Helsinki




Finland






Lipitor


20 mg


Film-coated tablet


Oral use




Finland







Pfizer Oy




Tietokuja 4




00330 Helsinki




Finland






Lipitor


40 mg


Film-coated tablet


Oral use




Finland







Pfizer Oy




Tietokuja 4




00330 Helsinki




Finland






Lipitor


80 mg


Film-coated tablet


Oral use




Finland







Pfizer Oy




Tietokuja 4




00330 Helsinki




Finland






Orbeos


10 mg


Film-coated tablet


Oral use




Finland







Pfizer Oy




Tietokuja 4




00330 Helsinki




Finland






Orbeos


20 mg


Film-coated tablet


Oral use




Finland







Pfizer Oy




Tietokuja 4




00330 Helsinki




Finland






Orbeos


40 mg


Film-coated tablet


Oral use




Finland







Pfizer Oy




Tietokuja 4




00330 Helsinki




Finland






Orbeos


80 mg


Film-coated tablet


Oral use




France







Pfizer Holding France




23-25 Avenue du Docteur Lannelongue




75668 Paris Cedex 14




France






Tahor


10 mg


Film-coated tablet


Oral use




France







Pfizer Holding France




23-25 Avenue du Docteur Lannelongue




75668 Paris Cedex 14




France






Tahor


20 mg


Film-coated tablet


Oral use




France







Pfizer Holding France




23-25 Avenue du Docteur Lannelongue




75668 Paris Cedex 14




France






Tahor


40 mg


Film-coated tablet


Oral use




France







Pfizer Holding France




23-25 Avenue du Docteur Lannelongue




75668 Paris Cedex 14




France






Tahor


80 mg


Film-coated tablet


Oral use




Germany







Pfizer Pharma GmbH




Linkstraße 10




10785 Berlin




Germany






Sortis 10 mg


10 mg


Film-coated tablet


Oral use




Germany







Pfizer Pharma GmbH




Linkstraße 10




10785 Berlin




Germany






Sortis 20 mg


20 mg


Film-coated tablet


Oral use




Germany







Pfizer Pharma GmbH




Linkstraße 10




10785 Berlin




Germany






Sortis 40 mg


40 mg


Film-coated tablet


Oral use




Germany







Pfizer Pharma GmbH




Linkstraße 10




10785 Berlin




Germany






Sortis 80 mg


80 mg


Film-coated tablet


Oral use




Germany







Pfizer Pharma GmbH




Linkstraße 10




10785 Berlin




Germany






Liprimar 10 mg


10 mg


Film-coated tablet


Oral use




Germany







Pfizer Pharma GmbH




Linkstraße 10




10785 Berlin




Germany






Liprimar 20 mg


20 mg


Film-coated tablet


Oral use




Germany







Pfizer Pharma GmbH




Linkstraße 10




10785 Berlin




Germany






Liprimar 40 mg


40 mg


Film-coated tablet


Oral use




Germany







Pfizer Pharma GmbH




Linkstraße 10




10785 Berlin




Germany






Liprimar 80 mg


80 mg


Film-coated tablet


Oral use




Germany







Pfizer Pharma GmbH




Linkstraße 10




10785 Berlin




Germany






Atorvastatin Pfizer 10 mg


10 mg


Film-coated tablet


Oral use




Germany







Pfizer Pharma GmbH




Linkstraße 10




10785 Berlin




Germany






Atorvastatin Pfizer 20 mg


20 mg


Film-coated tablet


Oral use




Germany







Pfizer Pharma GmbH




Linkstraße 10




10785 Berlin




Germany






Atorvastatin Pfizer 40 mg


40 mg


Film-coated tablet


Oral use




Germany







Pfizer Pharma GmbH




Linkstraße 10




10785 Berlin




Germany






Atorvastatin Pfizer 80 mg


80 mg


Film-coated tablet


Oral use




Greece







Pfizer Hellas A. E.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens




Greece






Lipitor


10 mg


Film-coated tablet


Oral use




Greece







Pfizer Hellas A. E.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens




Greece






Lipitor


20 mg


Film-coated tablet


Oral use




Greece







Pfizer Hellas A. E.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens




Greece






Lipitor


40 mg


Film-coated tablet


Oral use




Greece







Pfizer Hellas A. E.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens




Greece






Lipitor


80 mg


Film-coated tablet


Oral use




Greece







WIN MEDICA Ltd




41 Papadiamantopoulou Street




115 28 Ilisia, Athens




Greece






Zarator


10 mg


Film-coated tablet


Oral use




Greece







WIN MEDICA Ltd




41 Papadiamantopoulou Street




115 28 Ilisia,




Athens




Greece






Zarator


20 mg


Film-coated tablet


Oral use




Greece







WIN MEDICA Ltd




41 Papadiamantopoulou Street




115 28 Ilisia,




Athens




Greece






Zarator


40 mg


Film-coated tablet


Oral use




Greece







Pfizer Hellas A. E.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens,




Greece






Edovin


10 mg


Film-coated tablet


Oral use




Greece







Pfizer Hellas A. E.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens,




Greece






Edovin


20 mg


Film-coated tablet


Oral use




Greece







Pfizer Hellas A. E.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens,




Greece






Edovin


40 mg


Film-coated tablet


Oral use




Hungary







Pfizer KFT,




1123 Budapest,




Alkotás u. 53. MOM Park ‘F’ Ép.




Hungary






Sortis


10 mg


Film-coated tablet


Oral use




Hungary







Pfizer KFT,




1123 Budapest,




Alkotás u. 53. MOM Park ‘F’ Ép.




Hungary






Sortis


20 mg


Film-coated tablet


Oral use




Hungary







Pfizer KFT,




1123 Budapest,




Alkotás u. 53. MOM Park ‘F’ Ép.




Hungary






Sortis


40 mg


Film-coated tablet


Oral use




Hungary







Pfizer KFT,




1123 Budapest,




Alkotás u. 53. MOM Park ‘F’ Ép.




Hungary






Sortis


80 mg


Film-coated tablet


Oral use




Hungary







C.P. Pharma Gyógyszerkereskedelmi Kft.




2040 Budaörs




Vasút u. 11.,




Hungary






Obradon


10 mg


Film-coated tablet


Oral use




Hungary







C.P. Pharma Gyógyszerkereskedelmi Kft.




2040 Budaörs




Vasút u. 11.




Hungary






Obradon


20 mg


Film-coated tablet


Oral use




Hungary







C.P. Pharma Gyógyszerkereskedelmi Kft.




2040 Budaörs




Vasút u. 11.




Hungary






Obradon


40 mg


Film-coated tablet


Oral use




Hungary







C.P. Pharma Gyógyszerkereskedelmi Kft.




2040 Budaörs




Vasút u. 11.




Hungary






Obradon


80 mg


Film-coated tablet


Oral use




Iceland







Pfizer ApS




Lautrupvang 8




2750 Ballerup




Denmark






Zarator


10 mg


Film-coated tablet


Oral use




Iceland







Pfizer ApS




Lautrupvang 8




2750 Ballerup




Denmark






Zarator


20 mg


Film-coated tablet


Oral use




Iceland







Pfizer ApS




Lautrupvang 8




2750 Ballerup




Denmark






Zarator


40 mg


Film-coated tablet


Oral use




Iceland







Pfizer ApS




Lautrupvang 8




2750 Ballerup




Denmark






Zarator


80 mg


Film-coated tablet


Oral use




Ireland







Pfizer Ireland Pharmaceuticals,




Pottery Road, Dun Laoghaire, Co Dublin




Ireland






Lipitor


10 mg


Film-coated tablet


Oral use




Ireland







Pfizer Ireland Pharmaceuticals,




Pottery Road, Dun Laoghaire, Co Dublin




Ireland






Lipitor


20 mg


Film-coated tablet


Oral use




Ireland







Pfizer Ireland Pharmaceuticals,




Pottery Road, Dun Laoghaire, Co Dublin




Ireland






Lipitor


40 mg


Film-coated tablet


Oral use




Ireland







Pfizer Ireland Pharmaceuticals,




Pottery Road, Dun Laoghaire, Co Dublin




Ireland






Lipitor


80 mg


Film-coated tablet


Oral use




Italy







Pfizer Italia S.r.l.




Via Isonzo, 71




04100 Latina




Italy






Xarator


10 mg


Film-coated tablet


Oral use




Italy







Pfizer Italia S.r.l.




Via Isonzo, 71




04100 Latina




Italy






Xarator


20 mg


Film-coated tablet


Oral use




Italy







Pfizer Italia S.r.l.




Via Isonzo, 71




04100 Latina




Italy






Xarator


40 mg


Film-coated tablet


Oral use




Italy







Pfizer Italia S.r.l.




Via Isonzo, 71




04100 Latina




Italy






Xarator


80 mg


Film-coated tablet


Oral use




Italy







Bioindustria Farmaceutici S.r.l




Via Isonzo, 71




04100 Latina




Italy






Lipitor


10 mg


Film-coated tablet


Oral use




Italy







Bioindustria Farmaceutici S.r.l




Via Isonzo, 71




04100 Latina




Italy






Lipitor


20 mg


Film-coated tablet


Oral use




Italy







Bioindustria Farmaceutici S.r.l




Via Isonzo, 71




04100 Latina




Italy






Lipitor


40 mg


Film-coated tablet


Oral use




Italy







Bioindustria Farmaceutici S.r.l




Via Isonzo, 71




04100 Latina




Italy






Lipitor


80 mg


Film-coated tablet


Oral use




Italy







Pfizer Italia S.r.l.




Via Isonzo, 71




04100 Latina




Italy






Torvast


10 mg


Film-coated tablet


Oral use




Italy







Pfizer Italia S.r.l.




Via Isonzo, 71




04100 Latina




Italy






Torvast


20 mg


Film-coated tablet


Oral use




Italy







Pfizer Italia S.r.l.




Via Isonzo, 71




04100 Latina




Italy






Torvast


40 mg


Film-coated tablet


Oral use




Italy







Pfizer Italia S.r.l.




Via Isonzo, 71




04100 Latina




Italy






Torvast


80 mg


Film-coated tablet


Oral use




Italy







Laboratori Guidotti S.p.A.




Via Livornese 897 - La Vettola




56122 Pisa




Italy






Totalip


10 mg


Film-coated tablet


Oral use




Italy







Laboratori Guidotti S.p.A.




Via Livornese 897 - La Vettola




56122 Pisa




Italy






Totalip


20 mg


Film-coated tablet


Oral use




Italy







Laboratori Guidotti S.p.A.




Via Livornese 897 - La Vettola




56122 Pisa




Italy






Totalip


40 mg


Film-coated tablet


Oral use




Italy







Laboratori Guidotti S.p.A.




Via Livornese 897 - La Vettola




56122 Pisa




Italy






Totalip


80 mg


Film-coated tablet


Oral use




Latvia







Pfizer Limited




Ramsgate Road, Sandwich




Kent CT13 9NJ




United Kingdom






Sortis


10 mg


Film-coated tablet


Oral use




Latvia







Pfizer Limited




Ramsgate Road, Sandwich




Kent CT13 9NJ




United Kingdom






Sortis


20 mg


Film-coated tablet


Oral use




Latvia







Pfizer Limited




Ramsgate Road, Sandwich




Kent CT13 9NJ




United Kingdom






Sortis


40 mg


Film-coated tablet


Oral use




Latvia







Pfizer Limited




Ramsgate Road, Sandwich




Kent CT13 9NJ




United Kingdom






Sortis


80 mg


Film-coated tablet


Oral use




Lithuania







Pfizer Limited




Ramsgate Road, Sandwich




Kent CT13 9NJ




United Kingdom






Sortis


10 mg


Film-coated tablet


Oral use




Lithuania







Pfizer Limited




Ramsgate Road, Sandwich




Kent CT13 9NJ




United Kingdom






Sortis


20 mg


Film-coated tablet


Oral use




Lithuania







Pfizer Limited




Ramsgate Road, Sandwich




Kent CT13 9NJ




United Kingdom






Sortis


40 mg


Film-coated tablet


Oral use




Lithuania







Pfizer Limited




Ramsgate Road, Sandwich




Kent CT13 9NJ




United Kingdom






Sortis


80 mg


Film-coated tablet


Oral use




Luxembourg







Pfizer SA




Boulevard de la Plaine 17




B-1050 Brussels




Belgium






Lipitor


10 mg


Film-coated tablet


Oral use




Luxembourg







Pfizer SA




Boulevard de la Plaine 17




B-1050 Brussels




Belgium






Lipitor


20 mg


Film-coated tablet


Oral use




Luxembourg







Pfizer SA




Boulevard de la Plaine 17




B-1050 Brussels




Belgium






Lipitor


40 mg


Film-coated tablet


Oral use




Luxembourg







Pfizer SA




Boulevard de la Plaine 17




B-1050 Brussels




Belgium






Lipitor


80 mg


Film-coated tablet


Oral use




Malta







Pfizer Hellas S.A.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens,




Greece






Lipitor


10 mg


Film-coated tablet


Oral use




Malta







Pfizer Hellas S.A.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens,




Greece






Lipitor


20 mg


Film-coated tablet


Oral use




Malta







Pfizer Hellas S.A.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens,




Greece






Lipitor


40 mg


Film-coated tablet


Oral use




Malta







Pfizer Hellas S.A.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens,




Greece






Lipitor


80 mg


Film-coated tablet


Oral use




Netherlands







Pfizer bv




Rivium Westlaan 142




2909 LD Capelle a/d IJssel




The Netherlands






Lipitor 10


10 mg


Film-coated tablet


Oral use




Netherlands







Pfizer bv




Rivium Westlaan 142




2909 LD Capelle a/d IJssel




The Netherlands






Lipitor 20


20 mg


Film-coated tablet


Oral use




Netherlands







Pfizer bv




Rivium Westlaan 142




2909 LD Capelle a/d IJssel




The Netherlands






Lipitor 40


40 mg


Film-coated tablet


Oral use




Netherlands







Pfizer bv




Rivium Westlaan 142




2909 LD Capelle a/d IJssel




The Netherlands






Lipitor 80


80 mg


Film-coated tablet


Oral use




Norway







Pfizer AS




Pb. 3




1324 Lysaker




Norway






Lipitor


10 mg


Film-coated tablet


Oral use




Norway







Pfizer AS




Pb. 3




1324 Lysaker




Norway






Lipitor


20 mg


Film-coated tablet


Oral use




Norway







Pfizer AS




Pb. 3




1324 Lysaker




Norway






Lipitor


40 mg


Film-coated tablet


Oral use




Norway







Pfizer AS




Pb. 3




1324 Lysaker




Norway






Lipitor


80 mg


Film-coated tablet


Oral use




Poland







Pfizer Europe MA EEIG,




Ramsgate Road, Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis 10


10 mg


Film-coated tablet


Oral use




Poland







Pfizer Europe MA EEIG,




Ramsgate Road, Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis 20


20 mg


Film-coated tablet


Oral use




Poland







Pfizer Europe MA EEIG,




Ramsgate Road, Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis 40


40 mg


Film-coated tablet


Oral use




Poland







Pfizer Polska Sp.z o.o.




ul. Rzymowskiego 28




02-697 Warszawa




Poland






Sortis 80


80 mg


Film-coated tablet


Oral use




Portugal







Laboratorios Pfizer, Lda.




Lagoas Park, Edifício 10




2740-271 Porto Salvo




Portugal






Zarator


10 mg


Film-coated tablet


Oral use




Portugal







Laboratorios Pfizer, Lda.




Lagoas Park, Edifício 10




2740-271 Porto Salvo




Portugal






Zarator


20 mg


Film-coated tablet


Oral use




Portugal







Laboratorios Pfizer, Lda.




Lagoas Park, Edifício 10




2740-271 Porto Salvo




Portugal






Zarator


40 mg


Film-coated tablet


Oral use




Portugal







Laboratorios Pfizer, Lda.




Lagoas Park, Edifício 10




2740-271 Porto Salvo




Portugal






Zarator


80 mg


Film-coated tablet


Oral use




Portugal







Parke-Davis - Produtos Farmaceuticos Lda.




Lagoas Park, Edifício 10




2740-271 Porto Salvo




Portugal






Atorvastatina Parke-Davis


10 mg


Film-coated tablet


Oral use




Portugal







Parke-Davis - Produtos Farmaceuticos Lda.




Lagoas Park, Edifício 10




2740-271 Porto Salvo




Portugal






Atorvastatina Parke-Davis


20 mg


Film-coated tablet


Oral use




Portugal







Parke-Davis - Produtos Farmaceuticos Lda.




Lagoas Park, Edifício 10




2740-271 Porto Salvo




Portugal






Atorvastatina Parke-Davis


40 mg


Film-coated tablet


Oral use




Portugal







Parke-Davis - Produtos Farmaceuticos Lda.




Lagoas Park, Edifício 10




2740-271 Porto Salvo




Portugal






Atorvastatina Parke-Davis


80 mg


Film-coated tablet


Oral use




Portugal







Farmogene - Produtos Farmacêuticos, Lda




Lagoas Park, Edifício 10




2740-271 Porto Salvo




Portugal






Texzor


10 mg


Film-coated tablet


Oral use




Portugal







Farmogene - Produtos Farmacêuticos, Lda




Lagoas Park, Edifício 10




2740-271 Porto Salvo




Portugal






Texzor


20 mg


Film-coated tablet


Oral use




Portugal







Farmogene - Produtos Farmacêuticos, Lda




Lagoas Park, Edifício 10




2740-271 Porto Salvo




Portugal






Texzor


40 mg


Film-coated tablet


Oral use




Portugal







Farmogene - Produtos Farmacêuticos, Lda




Lagoas Park, Edifício 10




2740-271 Porto Salvo




Portugal






Texzor


80 mg


Film-coated tablet


Oral use




Romania







Pfizer Europe MA EEIG




Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


10 mg


Film-coated tablet


Oral use




Romania







Pfizer Europe MA EEIG




Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


20 mg


Film-coated tablet


Oral use




Romania







Pfizer Europe MA EEIG




Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


40 mg


Film-coated tablet


Oral use




Romania







Pfizer Europe MA EEIG




Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


80 mg


Film-coated tablet


Oral use




Slovak Republic







Pfizer Europe MA EEIG




Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


10 mg


Film-coated tablet


Oral use




Slovak Republic







Pfizer Europe MA EEIG




Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


20 mg


Film-coated tablet


Oral use




Slovak Republic







Pfizer Europe MA EEIG




Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


40 mg


Film-coated tablet


Oral use




Slovak Republic







Pfizer Europe MA EEIG




Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


80 mg


Film-coated tablet


Oral use




Slovenia







Pfizer Luxembourg SARL




51, Avenue J. F. Kennedy




L-1855 Luxembourg




Luxembourg






Sortis 10 mg filmsko obložene tablete


10 mg


Film-coated tablet


Oral use




Slovenia







Pfizer Luxembourg SARL




51, Avenue J. F. Kennedy




L-1855 Luxembourg




Luxembourg






Sortis 20 mg filmsko obložene tablete


20 mg


Film-coated tablet


Oral use




Slovenia







Pfizer Luxembourg SARL




51, Avenue J. F. Kennedy




L-1855 Luxembourg




Luxembourg






Sortis 40 mg filmsko obložene tablete


40 mg


Film-coated tablet


Oral use




Slovenia







Pfizer Luxembourg SARL




51, Avenue J. F. Kennedy




L-1855 Luxembourg




Luxembourg






Sortis 80 mg filmsko obložene tablete


80 mg


Film-coated tablet


Oral use




Spain







Parke Davis. S.L.




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Zarator 10 mg comprimidos recubiertos con película


10 mg


Film-coated tablet


Oral use




Spain







Parke Davis. S.L.




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Zarator 20 mg comprimidos recubiertos con película


20 mg


Film-coated tablet


Oral use




Spain







Parke Davis. S.L.




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Zarator 40 mg comprimidos recubiertos con película


40 mg


Film-coated tablet


Oral use




Spain







Parke Davis. S.L.




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Zarator 80 mg comprimidos recubiertos con película


80 mg


Film-coated tablet


Oral use




Spain







Pfizer, S.A.




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Cardyl 10 mg comprimidos recubiertos con película


10 mg


Film-coated tablet


Oral use




Spain







Pfizer, S.A.




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Cardyl 20 mg comprimidos recubiertos con película


20 mg


Film-coated tablet


Oral use




Spain







Pfizer, S.A.




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Cardyl 40 mg comprimidos recubiertos con película


40 mg


Film-coated tablet


Oral use




Spain







Pfizer, S.A.




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Cardyl 80 mg comprimidos recubiertos con película


80 mg


Film-coated tablet


Oral use




Spain







Nostrum Farma, S.A.,




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Atorvastatina Nostrum 10 mg comprimidos recubiertos con película


10 mg


Film-coated tablet


Oral use




Spain







Nostrum Farma, S.A.,




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Atorvastatina Nostrum 20 mg comprimidos recubiertos con película


20 mg


Film-coated tablet


Oral use




Spain







Nostrum Farma, S.A.,




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Atorvastatina Nostrum 40 mg comprimidos recubiertos con película


40 mg


Film-coated tablet


Oral use




Spain







Nostrum Farma, S.A.,




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Atorvastatina Nostrum 80 mg comprimidos recubiertos con película


80 mg


Film-coated tablet


Oral use




Spain







PHARMACIA GRUPO PFIZER, S.L.




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Atorvastatina Pharmacia 10 mg comprimidos recubiertos con película


10 mg


Film-coated tablet


Oral use




Spain







PHARMACIA GRUPO PFIZER, S.L.




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Atorvastatina Pharmacia 20 mg comprimidos recubiertos con película


20 mg


Film-coated tablet


Oral use




Spain







PHARMACIA GRUPO PFIZER, S.L.




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Atorvastatina Pharmacia 40 mg comprimidos recubiertos con película


40 mg


Film-coated tablet


Oral use




Spain







PHARMACIA GRUPO PFIZER, S.L.




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Atorvastatina Pharmacia 80 mg comprimidos recubiertos con película


80 mg


Film-coated tablet


Oral use




Spain







Almirall S.A.




General Mitre, 151




08022 - Barcelona




Spain






Prevencor 10 mg comprimidos recubiertos con película


10 mg


Film-coated tablet


Oral use




Spain







Almirall S.A.




General Mitre, 151




08022 - Barcelona




Spain






Prevencor 20 mg comprimidos recubiertos con película


20 mg


Film-coated tablet


Oral use




Spain







Almirall S.A.




General Mitre, 151




08022 - Barcelona




Spain






Prevencor 40 mg comprimidos recubiertos con película


40 mg


Film-coated tablet


Oral use




Spain







Almirall S.A.




General Mitre, 151




08022 - Barcelona




Spain






Prevencor 80 mg comprimidos recubiertos con película


80 mg


Film-coated tablet


Oral use




Sweden







Pfizer AB




191 90 Sollentuna




Sweden






Lipitor


10 mg


Film-coated tablet


Oral use




Sweden







Pfizer AB




191 90 Sollentuna




Sweden






Lipitor


20 mg


Film-coated tablet


Oral use




Sweden







Pfizer AB




191 90 Sollentuna




Sweden






Lipitor


40 mg


Film-coated tablet


Oral use




Sweden







Pfizer AB




191 90 Sollentuna




Sweden






Lipitor


80 mg


Film-coated tablet


Oral use




United Kingdom







Pfizer Ireland Pharmaceuticals,




Pottery Road Dun Laoghaire, Co Dublin




Ireland






Lipitor


10 mg


Film-coated tablet


Oral use




United Kingdom







Pfizer Ireland Pharmaceuticals,




Pottery Road Dun Laoghaire, Co Dublin




Ireland






Lipitor


20 mg


Film-coated tablet


Oral use




United Kingdom







Pfizer Ireland Pharmaceuticals,




Pottery Road Dun Laoghaire, Co Dublin




Ireland






Lipitor


40 mg


Film-coated tablet


Oral use




United Kingdom







Pfizer Ireland Pharmaceuticals,




Pottery Road




Dun Laoghaire, Co Dublin




Ireland






Lipitor


80 mg


Film-coated tablet


Oral use







ANNEX II

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













Member State EU/EEA


Marketing authorisation holder


Applicant


(Invented) Name


Strength


Pharmaceutical form


Route of administration


Content
(concentration)




Ireland







CHX Technologies Europe Limited




Guinness Enterprise Centre




Taylor’s Lane




Dublin 8, Ireland






 


Prevora 100 mg/ml Dental Solution


100 mg per ml solution


Dental solution


Dental use (supra-gingival to the hard tissue only)


100 mg/ml




United Kingdom


 







CHX Technologies Europe Limited




Guinness Enterprise Centre




Taylor’s Lane




Dublin 8, Ireland






Prevora 100 mg/ml Dental Solution


100 mg per ml solution


Dental solution


Dental use (supra-gingival to the hard tissue only)


100 mg/ml







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


Marketing Authorisation Holder


Product name


Strength


Pharmaceutical form


Route of administration




AT - Austria







A.Menarini Industrie Farmaceutiche Riunite s.r.l.




1-3 Via Sette Santi




50131 Firenze




Italy






Fastum Gel


25 mg/g


Gel


Cutaneous use




AT - Austria







Cyathus Exquirere Pharmaforschungs GmbH




Rudolfsplatz 2/1/8




1010 Wien




Austria






Ketospray 10 % - Spray


100 mg/g
metered dose: 20 mg/0,2 ml


Cutaneous spray, solution


Cutaneous use




AT - Austria







sanofi-aventis GmbH




SATURN Tower, Leonard-Bernstein-Straße 10




1220 Wien




Austria






Profenid 2,5 % - Gel


25 mg/g


Gel


Cutaneous use




BE - Belgium







Aktuapharma N.V




Ambachtenlaan 13E




3001 Leuven




Belgium






Fastum gel 2,5 %


25 mg/g


Gel


Cutaneous use




BE - Belgium







Menarini Benelux N.V




Belgicastraat 4




1930 Zaventem




Belgium






Fastum 2,5 %


25 mg/g


Gel


Cutaneous use




BE - Belgium







Menarini Benelux N.V




Belgicastraat 4




1930 Zaventem




Belgium






Fastum gel 2,5 %


25 mg/g


Gel


Cutaneous use




BE - Belgium







Pharmapartner NV




Bleyveldstraat 19




3320 Hoegaarden




Belgium






Fastum gel


25 mg/g


Gel


Cutaneous use




BG - Bulgaria







VET PROM JSCO




26, ‘Otez Paissij’ street




2400 Radomir




Bulgaria






Ketoprofen Vetprom


2,5 %


Gel


Cutaneous use




BG - Bulgaria







A.MENARINI Industrie Farmaceutiche Riunite s.r.l., (Menarini Group),




Via Sette Santi 3,




50131 Florence,




Italy






Fastum


2,5 %


Gel


Cutaneous use




BG - Bulgaria







Cyathus Exquirere Pharmaforschungs GmbH,




Rudolfsplatz 2/1/8,




1010 Vienna,




Austria






Ketospray


0,1 %


Cutaneous spray, solution


Cutaneous use




BG - Bulgaria







Actavis




29, Atanas Dukov str.




1407 Sofia




Bulgaria






Topogel


2,5 %


Gel


Cutaneous use




BG - Bulgaria







Sanofi-aventis Bulgaria EOOD




103, Alexander Stamboliiski Bld.




Office Building Sofia Tower




Sofia 1303




Bulgaria






Profenid


2,5 %


Gel


Cutaneous use




BG - Bulgaria







Sopharma AD,




16 Iliensko Shousse Street




1220 Sofia




Bulgaria






Ketoprofen Sopharma


2,5 %


Gel


Cutaneous use




CY - Cyprus







A. Menarini Industrie Farmaceutiche Riunite SRL,




Via Delle Sette Santi 3




50131 Florence




Italy






FASTUM GEL 2,5 %


2,5 %


Gel


Cutaneous Use




CZ - Czech Republic







A. Menarini Industrie Farmaceutiche Riunite S.r.l.




Via Sette Santi 3,




50131 Florencie




Italy






FASTUM GEL


25 mg (2,5 %)/gm


Gel


Cutaneous Use




CZ - Czech Republic







CYATHUS Exquirere Pharmaforschungs GmbH,




Rudolfsplatz 2/8,




1010 Vienna,




Austria






PRONTOFLEX 10 %


100 mg/ml


Cutaneous spray, solution


Cutaneous Use




CZ - Czech Republic







Hisamitsu UK Limited




500 Chiswick High Road




London W4 5RG




United Kingdom






KEPLAT


20 mg


Medicated plaster


Cutaneous Use




CZ - Czech Republic







Lek Pharmaceuticals d.d.




Verovskova 57




SI-1000 Ljubljana




Slovenia






KETONAL 5 % KRÉM


50 mg/g


Cream


Cutaneous Use




CZ - Czech Republic







sanofi-aventis s.r.o.,




Evropská 846/176a, 160 00




Prague 6




Czech Republic






PROFENID GEL


25 mg/g


Gel


Cutaneous Use




DE - Germany







HEXAL AG




Industriestr. 25




D-83607 Holzkirchen,




Germany






Advel Schmerzgel 2,5 % Gel


25 mg/g


Gel


Cutaneous use




DE - Germany







Kreussler & Co. GmbH Chemische Fabrik




Rheingaustr. 87-93




D-65203 Wiesbaden




Germany






Phardol Schmerz-Gel


25 mg/g


Gel


Cutaneous use




DE - Germany







Madaus GmbH




Colonia-Allee 15




D-51067 Köln




Germany






Reparil SchmerzGel


25 mg/g


Gel


Cutaneous use




DE - Germany







McNeil GmbH & Co. oHG




Johnson & Johnson Platz 2




D-41470 Neuss,




Germany






Dolormin Schmerzgel mit Ketoprofen 2,5 %


25 mg/g


Gel


Cutaneous use




DE - Germany







TEOFARMA S.R.L.




Via F.IIi Cervi 8




I-27010 Valle Salimbene (PV)




Italy






Effekton Gel mit Ketoprofen


25 mg/g


Gel


Cutaneous use




DK - Denmark







A. Menarini Industrie Farmaceutiche Riunite S.r.l.




Via Sette Santi 3




IT-50131 Firenze




Italy






Fastum Gel


2,5 %


Gel


Cutaneous use




DK - Denmark







Antula Healthcare AB




Östermalmsgatan 19




SE-11426 Stockholm




Sweden






Zon


2,5 %


Gel


Cutaneous use




DK - Denmark







Nordic Drugs AB,




P.O. 30035, Geijersgatan 2A




SE-21618 Limhamn




Sweden






Ketospray


100 mg/g


Cutaneous spray, solution


Cutaneous use




DK - Denmark







Sanofi-Aventis




Slotsmarken 13




DK-2970 Hørsholm




Denmark






Orudis


25 mg/g


Gel


Cutaneous use




EE - Estonia







Sandoz d.d.




Verovskova 57




1000 Ljubljana




Slovenia






KETONAL


25 mg/1 mg


Gel


Cutaneous use




EE - Estonia







AS Grindeks




Krustpils 53




LV-1057 Riga




Latvia






BEGSAN


25 mg/1 mg


Gel


Cutaneous use




EE - Estonia







Lorenzo Pharma OÜ




Koidu 20-19




10136 Tallinn




Estonia






PRONTOFLEX


100 mg/1 g


Cutaneous spray, solution


Cutaneous use




EE - Estonia







A. Menarini Industrie Farmaceutiche Riunite s.r.l.




Via Sette Santi 3




Florence




Italy






FASTUM


25 mg/1 g


Gel


Cutaneous use




EE - Estonia







Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2




11317 Tallinn




Estonia






PROFENID


25 mg/1 g


Gel


Cutaneous use




EL - Greece







Uni-Pharma, Kleon Tsetis, Pharmaceutical Laboratories ABEE




14 Km National Highway




Athens-Lamia




Kifissia 14564




Greece






DRASTIREL


2,5 %


Cream


Cutaneous use




EL - Greece







Guidotti Hellas AE




An. Damvergi 7




Athens 10445




Greece






MENARIL


2,5 %


Gel


Cutaneous use




ES - Spain







LABORATORIOS MILO, S.A.




Los Angeles, 60. Pol. Ind. Centrovía




La Muela. 50196 Zaragoza




Spain






Arcental crema


10 mg/g


Cream


Cutaneous use




ES - Spain







Laboratorios Menarini,




S.A. Alfonso XII, 587




08918 Badalona (Barcelona)




Spain






Fastum gel


25 mg/g


Gel


Cutaneous use




ES - Spain







Pierre Fabre Ibérica S.A.




Ramón Trías Fargas, 7-11




08005 Barcelona




Spain






Extraplus gel


25 mg/g


Gel


Cutaneous use




ES - Spain







Sanofi Aventis S.A.




Josep Plá, 2




08019 Barcelona




Spain






Orudis gel


25 mg/g


Gel


Cutaneous use




FI - Finland







Antula Healthcare AB,




Östermalmsgatan 19




11426 Stockholm




Sweden






ZON


2,5 %


Gel


Cutaneous use




FI - Finland







Orion Oyj,




Orionintie 1




02101 Espoo




Finland






KETORIN


2,5 %


Gel


Cutaneous use




FI - Finland







sanofi-aventis Oy,




Huopalahdentie 24




00351 Helsinki




Finland






ORUDIS


2,5 %


Gel


Cutaneous use




FR - France







Arrow Generiques




26 Avenue Tony Garnier




69 007 Lyon




France






KETOPROFENE ARROW


2,5 %


Gel, 60 g tube


Cutaneous use




FR - France







Biogaran




15 Boulevard Charles de Gaulle




92 700 Colombes




France






KETOPROFENE BIOGARAN


2,5 %


Gel, 60 g tube


Cutaneous use




FR - France







Biogaran




15 Boulevard Charles de Gaulle




92 700 Colombes




France






KETOPROFENE BGR


2,5 %


Gel, 60 g tube


Cutaneous use




FR - France







Biogaran




15 Boulevard Charles de Gaulle




92 700 Colombes




France






KETOPROFENE BGR


2,5 %


Gel, 120 g tube


Cutaneous use




FR - France







Biogaran




15 Boulevard Charles de Gaulle




92 700 Colombes




France






KETOPROFENE BGR


2,5 %


Gel, 120 g measuring tube


Cutaneous use




FR - France







Cediat Mediffusion




11 bis rue du Colisée




75 008 PARIS




France






KETOPROFENE MEDIFFUSION


2,5 %


Gel, 60 g tube


Cutaneous use




FR - France







Cediat Mediffusion




11 bis rue du Colisée




75 008 PARIS




France






KETOPROFENE MEDIFFUSION


2,5 %


Gel, 120 g tube


Cutaneous use




FR - France







EG LABO




Laboratoires EuroGenerics




‘Le Quintet’ Bât.A




12 rue Danjou




92 517 Boulogne




Billancourt Cedex




France






KETOPROFENE EG


2,5 %


Gel, 60 g tube


Cutaneous use




FR - France







EG LABO




Laboratoires EuroGenerics




‘Le Quintet’ Bât.A




12 rue Danjou




92 517 Boulogne Billancourt Cedex




France






KETOPROFENE EG


2,5 %


Gel, 120 g tube


Cutaneous use




FR - France







EG LABO




Laboratoires EuroGenerics




‘Le Quintet’ Bât.A




12 rue Danjou




92 517 Boulogne Billancourt Cedex




France






KETOPROFENE EG


2,5 %


Gel, 120 g tube (HDPE)


Cutaneous use




FR - France







MENARINI France




1/7, rue du Jura




Zone Silic - Rungis




91320 WISSOUS




France






KETUM


2,5 %


Gel, 50 g aluminium tube


Cutaneous use




FR - France







MENARINI France




1/7, rue du Jura




Zone Silic - Rungis




91320 WISSOUS




France






KETUM


2,5 %


Gel, 60 g aluminium tube


Cutaneous use




FR - France







MENARINI France




1/7, rue du Jura




Zone Silic - Rungis




91320 WISSOUS




France






KETUM


2,5 %


Gel, 70 g aluminium tube


Cutaneous use




FR - France







MENARINI France




1/7, rue du Jura




Zone Silic - Rungis




91320 WISSOUS




France






KETUM


2,5 %


Gel, 60 g polyethylen polypropylen polyacetal tube


Cutaneous use




FR - France







MENARINI France




1/7, rue du Jura




Zone Silic - Rungis




91320 WISSOUS




France






KETUM


2,5 %


Gel, 120 g polyethylen polypropylen polyacetal tube


Cutaneous use




FR - France







MENARINI France




1/7, rue du Jura




Zone Silic - Rungis




91320 WISSOUS




France






KETUM


2,5 %


Gel, 70 g polyethylen polypropylen polyacetal tube


Cutaneous use




FR - France







MENARINI France




1/7, rue du Jura




Zone Silic - Rungis




91320 WISSOUS




France






KETOPROFENE MENARINI


2,5 %


Gel, 50 g aluminium tube


Cutaneous use




FR - France







MENARINI France




1/7, rue du Jura




Zone Silic - Rungis




91320 WISSOUS




France






KETOPROFENE MENARINI


2,5 %


gel, 60 g aluminium tube


Cutaneous use




FR - France







MENARINI France




1/7, rue du Jura




Zone Silic - Rungis




91320 WISSOUS




France






KETOPROFENE MENARINI


2,5 %


gel, 70 g aluminium tube


Cutaneous use




FR - France







Mylan SAS




117 allée des Parcs




69 800 Saint Priest




France






KETOPROFENE MYLAN


2,5 %


gel, 60 g tube


Cutaneous use




FR - France







Mylan SAS




117 allée des Parcs




69 800 Saint Priest




France






KETOPROFENE MYLAN


2,5 %


gel, 120 g tube


Cutaneous use




FR - France







Mylan SAS




117 allée des Parcs




69 800 Saint Priest




France






KETOPROFENE MYLAN


2,5 %


gel, 60 g measuring tube


Cutaneous use




FR - France







Mylan SAS




117 allée des Parcs




69 800 Saint Priest




France






KETOPROFENE MYLAN


2,5 %


gel, 120 g measuring tube


Cutaneous use




FR - France







Mylan SAS




117 allée des Parcs




69 800 Saint Priest




France






KETOPROFENE MYLAN PHARMA


2,5 %


gel, 60 g tube


Cutaneous use




FR - France







Mylan SAS




117 allée des Parcs




69 800 Saint Priest




France






KETOPROFENE MYLAN PHARMA


2,5 %


gel, 120 g tube


Cutaneous use




FR - France







Mylan SAS




117 allée des Parcs




69 800 Saint Priest




France






KETOPROFENE QUALIHEALTH


2,5 %


gel, 60 g tube


Cutaneous use




FR - France







Mylan SAS




117 allée des Parcs




69 800 Saint Priest




France






KETOPROFENE QUALIHEALTH


2,5 %


gel, 120 g tube


Cutaneous use




FR - France







Qualimed




117 allée des Parcs




69 800 SAINT PRIEST




France






KETOPROFENE QUALIMED


2,5 %


gel, 60 g tube


Cutaneous use




FR - France







Qualimed




117 allée des Parcs




69 800 SAINT PRIEST




France






KETOPROFENE QUALIMED


2,5 %


gel, 120 g tube


Cutaneous use




FR - France







Qualimed




117 allée des Parcs




69 800 SAINT PRIEST




France






KETOPROFENE QUALIMED


2,5 %


gel, 60 g measuring tube


Cutaneous use




FR - France







Qualimed




117 allée des Parcs




69 800 SAINT PRIEST




France






KETOPROFENE QUALIMED


2,5 %


gel, 120 g measuring tube


Cutaneous use




FR - France







RPG Ranbaxy




Pharmacie Génériques




4, Place Louis Armand




75012 PARIS




France






KETOPROFENE RPG


2,5 %


gel, 60 g tube


Cutaneous use




FR - France







Ratiopharm




19 boulevard Paul Vaillant Couturier




94 200 IVRY sur Seine




France






KETOPROFENE RATIOPHARM


2,5 %


gel, 60 g tube


Cutaneous use




FR - France







Ratiopharm




19 boulevard Paul Vaillant Couturier




94 200 IVRY sur Seine




France






KETOPROFENE RATIOPHARM


2,5 %


gel, 120 g tube


Cutaneous use




FR - France







Ratiopharm




19 boulevard Paul Vaillant Couturier




94 200 IVRY sur Seine




France






KETOPROFENE RATIO


2,5 %


gel, 60 g tube


Cutaneous use




FR - France







Ratiopharm




19 boulevard Paul Vaillant Couturier




94 200 IVRY sur Seine




France






KETOPROFENE RATIO


2,5 %


gel, 120 g tube


Cutaneous use




FR - France







Ratiopharm




19 boulevard Paul Vaillant Couturier




94 200 IVRY sur Seine




France






KETOPROFENE RATIO


2,5 %


gel, 120 g measuring tube


Cutaneous use




FR - France







Sandoz




49 Avenue Georges Pomidou




92 300 Levallois Perret




France






KETOPROFENE SANDOZ


2,5 %


gel, 60 g tube


Cutaneous use




FR - France







Sandoz




49 Avenue Georges Pomidou




92 300 Levallois Perret




France






KETOPROFENE SANDOZ


2,5 %


gel, 120 g tube


Cutaneous use




FR - France







Sandoz




49 Avenue Georges Pomidou




92 300 Levallois Perret




France






KETOPROFENE SANDOZ


2,5 %


gel, 120 g measuring tube


Cutaneous use




FR - France







Sanofi Aventis France




1-13 Boulevard Romain Rolland




75 014 PARIS




France






TOPREC


2,5 %


gel, 60 g tube


Cutaneous use




FR - France







Sanofi Aventis France




1-13 Boulevard Romain Rolland




75 014 PARIS




France






KETOPROFEN E WINTHROP


2,5 %


gel, 60 g tube


Cutaneous use




FR - France







Societe Agipharma




40 rue des Bergers




75 015 Paris




France






KETOPROFENE AGIPHARMA


2,5 %


gel, 60 g tube


Cutaneous use




FR - France







Societe Agipharma




40 rue des Bergers




75 015 Paris




France






KETOPROFENE AGIPHARMA


2,5 %


gel, 120 g tube


Cutaneous use




FR - France







Laboratoire Teva Sante




Le Palatin 1




1 cours du Triangle




92 936 Paris La Défense Cedex




France






KETOPROFENE TEVA


2,5 %


gel, 60 g tube


Cutaneous use




FR - France







Laboratoire Teva Sante




Le Palatin 1




1 cours du Triangle




92 936 Paris La Défense Cedex




France






KETOPROFENE TEVA SANTE


2,5 %


gel, 60 g tube


Cutaneous use




FR - France







Laboratoire Teva Sante




Le Palatin 1




1 cours du Triangle




92 936 Paris La Défense Cedex




France






KETOPROFENE TEVA SANTE


2,5 %


gel, 120 g tube


Cutaneous use




FR - France







Laboratoire Teva Sante




Le Palatin 1




1 cours du Triangle




92 936 Paris La Défense Cedex




France






KETOPROFENE TEVA SANTE


2,5 %


gel, 120 g measuring tube


Cutaneous use




FR - France







Zydus France




25 rue des Peupliers/ZAC Les Hautes Pâtures




Parc d'acticité des Peupliers




92 000 Nanterre




France






KETOPROFENE ZYDUS


2,5 %


gel, 60 g tube


Cutaneous use




HU - Hungary







A. Menarini Industrie Farnaceutiche Riunite s.r.l.




Via Sette Santi 3,




50131 Florence




Italy






FASTUM


25 mg/g


Gel


Cutaneous use




HU - Hungary







Goodwill Pharma Kft.




Cserzy Mihály u. 32




6724 Szeged




Hungary






KETOSPRAY


100 mg/g


Cutaneous spray, solution


Cutaneous use




HU - Hungary







Hisamitsu UK Ltd.




500 Chiswick High Road




London W4 5RG




United Kingdom






KEPLAT


20 mg


Medicated plaster


Transdermal use




HU - Hungary







sanofi-aventis zrt.




Tó u. 1-5




1045 Budapest




Hungary






ALGOFLEX GEL


25 mg/g


Gel


Cutaneous use




IE - Ireland







A. Menarini Srl




1-3 Via Sette Santi




P.O.Box 412




Florence




Italy






Fastum 2,5 % w/w Gel


2,5 % w/w


Gel


Cutaneous use




IE - Ireland







Sanofi-Aventis Ireland Ltd.




Citywest Business Campus




Dublin 24




Ireland






Orugesic 2,5 % w/w Gel


2,5 % w/w


Gel


Cutaneous use




IE - Ireland







Sanofi-Aventis Ireland Ltd.




Citywest Business Campus




Dublin 24




Ireland






Oruvail 2,5 % w/w Gel


2,5 % w/w


Gel


Cutaneous use




IS - Iceland







Sanofi-aventis Norge AS,




Strandveien 15, Box 133




1325 Lysaker




Norway






Orudis


25 mg/g


Gel


Cutaneous use




IT - Italy







A.Menarini




Ind.Farm.Riun.Srl




Via Sette Santi, 3




50131 - Firenze




Italy






Fastum


2,5 %


Gel


Cutaneous use




IT - Italy







A.Menarini




Ind.Farm.Riun.Srl




Via Sette Santi, 3




50131 - Firenze




Italy






Fastum


2,5 %


Cutaneous spray, solution


Cutaneous use




IT - Italy







Almus Srl




Via Cesarea, 11/10




16121 Genova




Italy






Ketoprofene Almus


5 %


Gel


Cutaneous use




IT - Italy







Bayer S.p.A.




Viale Certosa, 130




20156 Milano




Italy






Lasonil


2,5 %


Gel


Cutaneous use




IT - Italy







Bayer S.p.A.




Viale Certosa, 130




20156 Milano




Italy






Lasoartro


5 %


Cream


Cutaneous use




IT - Italy







Crinos S.p.A.




Via Pavia, 6




20136 Milano




Italy






Hiruflog


5 %


Gel


Cutaneous use




IT - Italy







Dompè Farmaceutici S.p.A.




Via San Martino, 12-12/A




20122 Milano




Italy






Artrosilene


5 %


Gel


Cutaneous use




IT - Italy







Dompè Farmaceutici S.p.A.




Via San Martino, 12-12/A




20122 Milano




Italy






Artrosilene


15 %


Cutaneous foam


Cutaneous use




IT - Italy







Dompè S.p.A.




Via Campo di Pile




67100 L'Aquila




Italy






Oki


15 %


Gel


Cutaneous use




IT - Italy







Eg S.p.A.




Via Domenico Scarlatti, 31




20124 Milano




Italy






Ketoprofene Eurogenerici


5 %


Gel


Cutaneous use




IT - Italy







Hisamitsu UK Limited




500 Chiswick Higth Road




London




United Kingdom






Keplat


20 mg


Medicated plaster


Cutaneous use




IT - Italy







I.B.I.Giovanni Lorenzini SpA




Via Fossignano, 2




04011 Aprilia (LT)




Italy






Ibifen


5 %


Gel


Cutaneous use




IT - Italy







I.B.I.Giovanni Lorenzini SpA




Via Fossignano, 2




04011 Aprilia (LT)




Italy






Ibifen


5 %


Cutaneous solution


Cutaneous use




IT - Italy







Italfarmaco S.p.A.




Viale Fulvio Testi, 330




20126 Milano




Italy






Flexen


2,5 %


Gel


Cutaneous use




IT - Italy







Italfarmaco S.p.A.




Viale Fulvio Testi, 330




20126 Milano




Italy






Flexen


5 %


Gel


Cutaneous use




IT - Italy







Ratiopharm Italia Srl




Centro Direzionale Milanofiori




20131 Assago (MI)




Italy






Ketoprofene Ratiopharm Italia


2,5 %


Gel


Cutaneous use




IT - Italy







Sandoz S.p.A.




Largo Boccioni, 1




21040 Origgio (VA),




Italy






Ketoprofene Sandoz


5 %


Cream


Cutaneous use




IT - Italy







Sanofi-Aventis S.p.A.




Viale Bodio, 37/B




20158 Milano




Italy






Liotondol


2,5 %


Gel


Cutaneous use




IT - Italy







Sanofi-Aventis S.p.A.




Viale Bodio, 37/B




20158 Milano




Italy






Orudis


2,5 %


Gel


Cutaneous use




IT - Italy







Sanofi-Aventis S.p.A.




Viale Bodio, 37/B




20158 Milano




Italy






Orudis


5 %


Gel


Cutaneous use




IT - Italy







Sanofi-Aventis S.p.A.




Viale Bodio, 37/B




20158 Milano




Italy






Orudis


1 %


Cream


Cutaneous use




IT - Italy







Sanofi-Aventis S.p.A.




Viale Bodio, 37/B




20158 Milano




Italy






Orudis


2,5 %


Cream


Cutaneous use




IT - Italy







Teikoku Pharma UK Ltd




7 Floor, Central House




Ballard Lane, Finchley




London




United Kingdom






Ketofarm


5 %


Gel


Cutaneous use




IT - Italy







Teva Italia Srl




Via Messina, 38




20154 Milano




Italy






Ketoprofene Teva


5 %


Gel


Cutaneous use




LT - Lithuania







A. Menarini Industrie Farmaceutiche Riunite s.r.l. 3




Via Sette Santi Florence




Italy






Fastum


25 mg/g


Gel


Cutaneous use




LT - Lithuania







GlaxoSmithKline Lietuva UAB




A. Goštauto 40A




LT-01112 Vilnius




Lithuania






Spinax


25 mg/g


Gel


Cutaneous use




LT - Lithuania







Sandoz d.d.




Verovskova 57




1000 Ljubljana




Slovenia






Ketonal


25 mg/g


Gel


Cutaneous use




LT - Lithuania







Sandoz d.d.,




Verovskova 57




1000 Ljubljana




Slovenia






Ketonal


50 mg/g


Cream


Cutaneous use




LT - Lithuania







UAB MRA




Totorių 20-9




LT-01121 Vilnius




Lithuania






Ketospray


100 mg/g


Cutaneous spray, solution


Cutaneous use




LU - Luxembourg







MENARINI BENELUX SA




Belgicastraat 4




B- 1930 Zaventem




Belgium






FASTUM


0,025


Gel


Cutaneous use




LV - Latvia







A. Menarini Industrie Farmaceutiche Riunite s.r.l. (Menarini Group),




Via Sette Santi 3




Florence, I - 50131




Italy






Fastum 2,5 % gel


25 mg/g


Gel


Cutaneous use




LV - Latvia







GlaxoSmithKline Latvia SIA




Bruņinieku iela 5




Rīga, LV-1001




Latvia






Spinax 25 mg/g gel


25 mg/g


Gel


Cutaneous use




LV - Latvia







Sandoz d.d.




Verovškova 57




Ljubljana Sl - 1000




Slovenia






Ketonal 2,5 % gel


25 mg/g


Gel


Cutaneous use




LV - Latvia







Sanofi-aventis Latvia SIA,




Kr.Valdemāra 33-8




Rīga, LV-1010




Latvia






Profenid 25 mg/g gel


25 mg/g


Gel


Cutaneous use




MT - Malta







A. Menarini industrie farmaceutici riunite S.R.L.




Via Sette Santi, 3




50131, Florence




Italy






Fastum gel 2,5 % w/w


0,025


Gel


Cutaneous Use




MT - Malta







A. Menarini industrie farmaceutici riunite S.R.L.




Via Sette Santi, 3




50131, Florence




Italy






Fastum gel 2,5 % w/w Dispenser


0,025


Gel


Cutaneous Use




MT - Malta







Dompé Farmaceutici SPA




Via San Martino 12




20122, Milan




Italy






Artrosilene 15 % cutaneous foam


15 g/100 ml


Cutaneous foam


Cutaneous Use




MT - Malta







Dompé Farmaceutici SPA




Via San Martino 12




20122, Milan




Italy






Artrosilene 5 % gel


5 g/100 g


Gel


Cutaneous Use




MT - Malta







Sanofi Aventis Malta ltd.




Triq Kanonku K. Pirotta




Bkara BKR1114




Malta






Profenid gel 2,5 % w/w


0,025


Gel


Cutaneous Use




NO - Norway







Antula Healthcare AB




Östermalmsgatan 19,




114 26 Stockholm




Sverige






Zon


2,5 %


Gel


Cutaneous use




NO - Norway







Sanofi-Aventis




Strandveien 15




1366 Lysaker




Norway






Orudis


2,5 %


Gel


Cutaneous use




PL - Poland







A.Menarini Pharmaceutical Industries Group Ltd.




3 Via Sette Santi




I-50 131 Florence




Italy






Fastum


25 mg/g


Gel


Cutaneous use




PL - Poland







GlaxoSmithKline Pharmaceuticals S.A




Grunwaldzka st. 189




60-322 Poznań




Poland






Ketoprom


25 mg/g


Gel


Cutaneous use




PL - Poland







Hisamitsu UK Limited




500 Chiswick High Road




London W4 5RG UK




United Kingdom






Keplat


20 mg


medicated plaster


Transdermal use




PL - Poland







Medagro International Sp.z o.o.




83 Podleśna St.,




05-552 Łazy k.




Warszawy




Poland






Ketospray Forte


100 mg/g


cutaneous spray, solution


Cutaneous use




PL - Poland







Medana Pharma S.A.




10 Władysława Łokietka st.




98-200 Sieradz




Poland






Ultrafastin


25 mg/g


Gel


Cutaneous use




PL - Poland







Sandoz GmbH




Biochemiestrasse 10




A-6250 Kundl




Austria






Ketonal Lek


25 mg/g


Gel


Cutaneous use




PL - Poland







Sanofi-Aventis France




boulevard Romain Rolland 1-13




F-75014 Paris




France






Profenid Gel


25 mg/g


Gel


Cutaneous use




PL - Poland







Zakłady Farmaceutyczne ‘UNIA’ Spółdzielnia Pracy




ul. Chłodna 56/60




00-872 Warsaw




Poland






Ketopronil


25 mg/g


Gel


Cutaneous use




PT - Portugal







A. Menarini Portugal - Farmacêutica, S.A.




Quinta da Fonte - Rua dos Malhões, 1 - Edifício D. Manuel I, Piso 2A




2770-071 Paço D'Arcos




Portugal






Fastum


25 mg/g


Gel


Cutaneous use




PT - Portugal







Hisamitsu UK Ltd.




500 Chiswick High Road




W4 5RG UK London




United Kingdom






Keplat


20 mg


Medicated plaster


Transdermal use




PT - Portugal







Laboratórios Vitória, S.A.




Rua Elias Garcia




28 - Venda Nova




2700-327 Amadora




Portugal






Profenid


25 mg/g


Gel


Cutaneous use




RO - Romania







A. Menarini Industrie Farmaceutiche Riunite S.R.L.




Via Sette Santi 3




Firenze




Italy






FASTUM GEL, gel, 2,5 %


25 mg/g


Gel


Cutaneous use




RO - Romania







CSC Pharmaceuticals Handels GmbH




Heiligenstadter Strasse 395 b




1190-Viena




Austria






KETOSPRAY 50 mg/ml, spray cutanat soluție


50 mg/ml


Cutaneous spray, solution


Cutaneous use




RO - Romania







Cyathus Exquirere PharmaforschungsGmbH




Rudolfsplatz 2/1/8




A-1010 Viena




Austria






KETOSpray 10 %, spray cutanat, soluție


100 mg/ml


Cutaneous spray, solution


Cutaneous use




RO - Romania







Laboratoires Aventis




46, quai de la Rapee




75012 Paris Cedex 12




France






PROFENID GEL, 2,5 %


25 mg/g


Gel


Cutaneous use




RO - Romania







LEK Pharmaceuticals D.D.,




Verovskova 57




1526 Ljublijana




Slovenia






KETONAL 2,5 % gel


25 mg/g


Gel


Cutaneous use




RO - Romania







Ozone Laboratories SRL,




Calea Rahovei nr. 266-268




Corp 60, Etaj 1, Sector 5




București




Romania






KETOPROFEN 25 mg/g GEL


25 mg/g


Gel


Cutaneous use




RO - Romania







S.C. Antibiotice S.A.




Str. Valea Lupului Nr. 1




Iași, jud. Iași




România






RUBIFEN 2,5 %,gel


25 mg/g


Gel


Cutaneous use




RO - Romania







S.C. Fiterman Pharma S.R.L.




Str. Moara de Foc nr. 35,




Iași 700520




România






KETOPROFEN MK, gel, 2,5 %


25 mg/g


Gel


Cutaneous use




RO - Romania







S.C. HYPERION S.A.




B-dul Independenței nr. 18




Bloc Y1, Etj. 8, Ap.4




Cod 700099, Iași




România






KETOPROFEN HYPERION 25 mg/g gel


25 mg/g


Gel


Cutaneous use




RO - Romania







S.C. Slavia Pharm S.R.L.,




Str. Știrbei Vodă nr. 53-55, sector 1




București,




România






KETOPROFEN SLAVIA 25 mg/g gel


25 mg/g


Gel


Cutaneous use




RO - Romania







S.C. Terapia S.A.,




Str. Fabricii, nr. 124




Cluj Napoca




România






KETOPROFEN, 25 mg/g, gel


25 mg/g


Gel


Cutaneous use




SE - Sweden







ACO Hud AB




Box 622




194 26 Upplands Väsby




Sweden






Ketoflex


2,5 %


Gel


Cutaneous use




SE - Sweden







Antula Healthcare AB, , Östermalmsgatan 19




114 26 Stockholm




Sweden






Zon


2,5 %


Gel


Cutaneous use




SE - Sweden







Meda AB,




Box 906




170 09 Solna




Sweden






Siduro


2,5 %


Gel


Cutaneous use




SE - Sweden







sanofi-aventis AB




Box 14142




167 14 Bromma




Sweden






Orudis


2,5 %


Gel


Cutaneous use




SI - Slovenia







Galex, d.d.




Tišinska ulica 29g




SI-9000 Murska Sobota,




Slovenia






Prontoflex 100 mg/g dermalno pršilo, raztopina


100 mg/g


Cutaneos spray, solution


Cutaneous use




SI - Slovenia







Lek farmacevtska družba, d.d., Verovškova 57




SI-1000 Ljubljana




Slovenia






Ketonal 25 mg/g gel


25 mg/g


Gel


Cutaneous use




SI - Slovenia







Lek farmacevtska družba, d.d., Verovškova 57




SI-1000 Ljubljana




Slovenia






Ketonal 50 mg/g krema


50 mg/g


Cream


Cutaneous use




SI - Slovenia







Menarini Industrie Farmaceutiche Riunite s.r.l.,




Via Sette Santi 3




Firenze I-50131




Italy






Fastum 25 mg/g gel


25 mg/g


Gel


Cutaneous use




SK - Slovakia







A. Menarini Industrie Farmaceutiche Riunite s.r.l.




Via Sette Santi 3




50131 Florence




Italy






FASTUM GEL


2,5 %


Gel


Cutaneous use




SK - Slovakia







Herbacos-Bofarma, s.r.o.




Štrossova 239




530 03 Pardubice




Czech Republic






KETOPROFEN BCH


2,5 %


Gel


Cutaneous use




SK - Slovakia







NTC Pharma, s.r.o.




Strečnianska 13




851 05 Bratislava




Slovakia






KETOSPRAY 10 %


100 mg / 1 ml


Cutaneous spray, solution


Cutaneous use




SK - Slovakia







Sandoz Pharmaceuticals d.d. Verovškova 57




1000 Ljubljana




Slovenia






Ketonal 2,5 % gél


2,5 %


Gel


Cutaneous use




UK - United Kingdom







A Menarini Industrie Farmaceutiche Riunite SRL




Via Sette Sante 3




50131 Florence




Italy






POWERGEL 2,5 % GEL


2,5 % W/W


Gel


Cutaneous use




UK - United Kingdom







A Menarini Industrie Farmaceutiche Riunite SRL




Via Sette Sante 3




50131 Florence




Italy






FASTUM GEL


2,5 % W/W


Gel


Cutaneous use




UK - United Kingdom







May & Baker Limited




50 King's Hill Avenue




King's Hill, West Malling




Kent ME19 4AH




United Kingdom






ORUVAIL GEL 2,5 %


2,5 % W/W


Gel


Cutaneous use




UK - United Kingdom







Pinewood Laboratories Limited Ballymacarbry




Clonmel, CO Tipperary




Ireland






KETOPROFEN 2,5 % W/W GEL


2,5 % W/W


Gel


Cutaneous use




UK - United Kingdom







Pliva Pharma Limited




Vision House, Bedford Road Petersfield




Hampshire GU32 3QB




United Kingdom






KETOPROFEN 2,5 % W/W GEL


2,5 % W/W


Gel


Cutaneous use




UK - United Kingdom







Tillomed Laboratories Limited




3 Howard Road




Eaton Socon, ST. Neots, Cambridgeshire PE19 8ET




United Kingdom






TILOKET GEL 2,5 %


2,5 % W/W


Gel


Cutaneous use