Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2012 to 30 September 2012 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2012-10-26
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2012328EN.01000801.xml










26.10.2012   


EN


Official Journal of the European Union


C 328/8





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2012 to 30 September 2012

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

2012/C 328/02
—   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




17.9.2012


Nuflor 300 mg/ml


See Annex I


See Annex I


18.9.2012




28.9.2012


Yvidually and associated names


See Annex II


See Annex II


3.10.2012




11.9.2012


Mifepristone Linepharma and associated names


See Annex III


See Annex III


13.9.2012




10.9.2012


Zinacef and associated names


See Annex IV


See Annex IV


11.9.2012




3.9.2012


Trimetazidine


See Annex V


See Annex V


4.9.2012






(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, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES












Member State EU/EEA


Applicant


Name


Pharmaceutical form


Strength


Animal species


Route of administration




Belgium







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




The Netherlands






Nuflor 300 mg/ml solution for injection for cattle and sheep


Solution for injection


300 mg/ml


Cattle and sheep


Cattle – subcutaneous and intramuscular
Sheep – intramuscular




Denmark







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




The Netherlands






Nuflor 300 mg/ml solution for injection for cattle and sheep


Solution for injection


300 mg/ml


Cattle and sheep


Cattle – subcutaneous and intramuscular
Sheep – intramuscular




France







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




The Netherlands






Nuflor 300 mg/ml solution for injection for cattle and sheep


Solution for injection


300 mg/ml


Cattle and sheep


Cattle – subcutaneous and intramuscular
Sheep – intramuscular




Germany







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




The Netherlands






Nuflor 300 mg/ml solution for injection for cattle and sheep


Solution for injection


300 mg/ml


Cattle and sheep


Cattle – subcutaneous and intramuscular
Sheep – intramuscular




Greece







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




The Netherlands






Nuflor 300 mg/ml solution for injection for cattle and sheep


Solution for injection


300 mg/ml


Cattle and sheep


Cattle – subcutaneous and intramuscular
Sheep – intramuscular




Ireland







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




The Netherlands






Nuflor 300 mg/ml solution for injection for cattle and sheep


Solution for injection


300 mg/ml


Cattle and sheep


Cattle – subcutaneous and intramuscular
Sheep – intramuscular




Italy







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




The Netherlands






Nuflor 300 mg/ml solution for injection for cattle and sheep


Solution for injection


300 mg/ml


Cattle and sheep


Cattle – subcutaneous and intramuscular
Sheep – intramuscular




Luxembourg







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




The Netherlands






Nuflor 300 mg/ml solution for injection for cattle and sheep


Solution for injection


300 mg/ml


Cattle and sheep


Cattle – subcutaneous and intramuscular
Sheep – intramuscular




The Netherlands







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




The Netherlands






Nuflor 300 mg/ml solution for injection for cattle and sheep


Solution for injection


300 mg/ml


Cattle and sheep


Cattle – subcutaneous and intramuscular
Sheep – intramuscular




Portugal







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




The Netherlands






Nuflor 300 mg/ml solution for injection for cattle and sheep


Solution for injection


300 mg/ml


Cattle and sheep


Cattle – subcutaneous and intramuscular
Sheep – intramuscular




Spain







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




The Netherlands






Nuflor 300 mg/ml solution for injection for cattle and sheep


Solution for injection


300 mg/ml


Cattle and sheep


Cattle – subcutaneous and intramuscular
Sheep – intramuscular




United Kingdom







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




The Netherlands






Nuflor 300 mg/ml solution for injection for cattle and sheep


Solution for injection


300 mg/ml


Cattle and sheep


Cattle – subcutaneous and intramuscular
Sheep – intramuscular







ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES











Member State EU/EEA


Applicant


Invented Name


Strength


Pharmaceutical form


Route of administration




Austria







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Delivrie 0,02 mg/3 mg Filmtabletten


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




Belgium







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Yvidually


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




Bulgaria







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Flexyess


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




Cyprus







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Flexyess


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




Czech Republic







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Flexyess


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




Denmark







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Delivrie


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




Estonia







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Yvidually


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




Finland







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Flexyess


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




France







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Flexyess


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




Germany







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Flexyess


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




Greece







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Flexyess


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




Hungary







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Flexyess


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




Iceland







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Delivrie


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




Ireland







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Delivrie


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




Italy







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Yvidually


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




Latvia







Bayer Pharma AG




Müllerstrasse 170-178




D-13353, Berlin




Germany






Yvidually 0,02 mg/3 mg apvalkotās tabletes


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




Lithuania







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Flexyess


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




Luxembourg







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Delivrie


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




Malta







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Flexyess


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




The Netherlands







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Yvidually


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




Norway







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Flexyess


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




Poland







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Flexyess


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




Portugal







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Flexyess


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




Romania







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Yvidually


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




Slovak Republic







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Flexyess


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




Slovenia







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Flexyess


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




Spain







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Delivrie


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




Sweden







Bayer B.V.




Energieweg 1,




3641 RT Mijdrecht




the Netherlands






Delivrie


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use




United Kingdom







Bayer plc, Bayer House Strawberry Hill




Newbury, Berkshire RG14 1JA




United Kingdom






Delivrie


ethinylestradiol: 0.02 mg
Drospirenone: 3 mg


film-coated tablet


Oral use







ANNEX III

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












Member State EU/EEA


Marketing authorisation holder


Applicant


Name


Strength


Pharmaceutical form


Route of administration




Denmark







Linepharma France,




140 bis rue de Rennes 75006 Paris




France






 


Mifepriston
Linepharma


200 mg


Tablet


Oral use




Finland







Linepharma France,




140 bis rue de Rennes 75006 Paris




France






 


Mifepristone Linepharma


200 mg


Tablet


Oral use




France


 







Linepharma France,




140 bis rue de Rennes 75006 Paris




France






Mifepristone
Linepharma
200 mg comprimé


200 mg


Tablet


Oral use




Iceland







Linepharma France,




140 bis rue de Rennes 75006 Paris




France






 


Mifepristone
Linepharma
200 mg Tafla


200 mg


Tablet


Oral use




Norway







Linepharma France,




140 bis rue de Rennes 75006 Paris




France






 


Mifepristone
Linepharma


200 mg


Tablet


Oral use




Sweden







Linepharma France,




140 bis rue de Rennes 75006 Paris




France






 


Mifepristone
Linepharma


200 mg


Tablet


Oral use




United Kingdom


 







Linepharma France,




140 bis rue de Rennes 75006 Paris




France






Mifepristone
Linepharma
200 mg tablet


200 mg


Tablet


Oral use







ANNEX IV

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


Invented name


Strength


Pharmaceutical Form


Route of administration


Content
(concentration)




Austria







GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,




A-1140 Wien




AUSTRIA






Curocef 1 500 mg - Trockenstechampullen


1,5 g


Powder for Injection or Infusion


Intravenous Use


Injection: 1,5 g/15 ml
Infusion: 1,5 g/15 ml + 50 ml or 100 ml




Austria







GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,




A-1140 Wien




AUSTRIA






Curocef 1 500 mg - Trockensubstanz zur Infusionsbereitung


1,5 g


Powder for Infusion


Intravenous Use


1,5 g/15 ml + 50 ml or 100 ml




Austria







GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,




A-1140 Wien




AUSTRIA






Curocef 250 mg - Trockenstechamupllen


250 mg


Powder for Injection


Intramuscular Use or Intravenous Use


250 mg/1 ml or 250 mg/2-5 ml




Austria







GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,




A-1140 Wien




AUSTRIA






Curocef 750 mg - Trockenstechampullen


750 mg


Powder for Injection


Intramuscular Use or Intravenous Use


750 mg/3 ml or 750 mg/6-10 ml




Belgium







GlaxoSmithKline s.a./n.v.




Rue du Tilleul 13




1332 Genval




BELGIUM






Zinacef


1,5 g


Powder for Solution for Infusion


Intravenous Use


1,5 g 50 ml




Belgium







GlaxoSmithKline s.a./n.v.




Rue du Tilleul 13




1332 Genval




BELGIUM






Zinacef


1,5 g


Powder for Solution for Injection


Intravenous Use


1,5 g 15 ml




Belgium







GlaxoSmithKline s.a./n.v.




Rue du Tilleul 13




1332 Genval




BELGIUM






Zinacef


750 mg


Powder for Solution for Injection


Intravenous Use


750 mg 6 ml




Bulgaria







Glaxo Group Ltd.,




Greenford, Middlesex UB6 0NN




UNITED KINGDOM






Zinacef


1,5 g


Powder for Solution for Injection


Intravenous Use


1,5 g 15 ml




Bulgaria







Glaxo Group Ltd.,




Greenford, Middlesex UB6 0NN




UNITED KINGDOM






Zinacef


750 mg


Powder for Solution for Injection


Intravenous Use


750 mg 6 ml




Bulgaria







Glaxo Group Ltd.,




Greenford, Middlesex UB6 0NN




UNITED KINGDOM






Zinacef


750 mg


Powder for Solution for Injection


Intramuscular Use


750 mg 3 ml




Cyprus







Glaxo Group Limited




Berkeley Avenue




Greenford




Middlex UB6 0NN




UNITED KINGDOM






Zinacef


1,5 g


Powder for Infusion


Intravenous Use


1,5 g 50 ml




Cyprus







Glaxo Group Limited




Berkeley Avenue




Greenford




Middlex UB6 0NN




UNITED KINGDOM






Zinacef


1,5 g


Powder for Injection


Intravenous Use


1,5 g 15 ml




Cyprus







Glaxo Group Limited




Berkeley Avenue




Greenford




Middlex UB6 0NN




UNITED KINGDOM






Zinacef


750 mg


Powder for Infusion


Intravenous Use


750 mg 6 ml




Cyprus







Glaxo Group Limited




Berkeley Avenue




Greenford




Middlex UB6 0NN




UNITED KINGDOM






Zinacef


750 mg


Powder for Injection


Intramuscular Use


750 mg 3 ml




Czech Republic







Glaxo Group Ltd.,




Glaxo Welcome House, Berkeley avenue, Greenford, Middlesex UB6 0NN




ENGLAND






Zinacef 1,5 g


1,5 g


Powder for Injection


Intravenous Use


1,5 g 50 ml




Czech Republic







Glaxo Group Ltd.,




Glaxo Welcome House, Berkeley avenue, Greenford, Middlesex UB6 0NN




ENGLAND






Zinacef 1,5 g


1,5 g


Powder for Injection


Intravenous Use


1,5 g 15 ml




Czech Republic







Glaxo Group Ltd.,




Glaxo Welcome House, Berkeley avenue, Greenford, Middlesex UB6 0NN




ENGLAND






Zinacef 750 mg


750 mg


Powder for Injection


Intramuscular Use


750 mg 3 ml




Czech Republic







Glaxo Group Ltd.,




Glaxo Welcome House, Berkeley avenue, Greenford, Middlesex UB6 0NN




ENGLAND






Zinacef 750 mg


750 mg


Powder for Injection


Intravenous Use


750 mg 6 ml




Denmark







GlaxoSmithKline Pharma A/S




Nykaer 68, 2605 Broendby




DENMARK






Zinacef


1,5 g


Powder for Solution for Infusion


Intravenous Use


1,5 g 50 ml




Denmark







GlaxoSmithKline Pharma A/S




Nykaer 68, 2605 Broendby




DENMARK






Zinacef


1,5 g


Powder for Solution for Injection


Intravenous Use


1,5 g 15 ml




Denmark







GlaxoSmithKline Pharma A/S




Nykaer 68, 2605 Broendby




DENMARK






Zinacef


250 mg


Powder for Solution for Injection


Intramuscular Use


250 mg 1 ml




Denmark







GlaxoSmithKline Pharma A/S




Nykaer 68, 2605 Broendby




DENMARK






Zinacef


250 mg


Powder for Solution for Injection


Intravenous Use


250 mg 2 ml




Denmark







GlaxoSmithKline Pharma A/S




Nykaer 68, 2605 Broendby




DENMARK






Zinacef


750 mg


Powder for Solution for Infusion


Intramuscular Use


750 mg 3 ml




Denmark







GlaxoSmithKline Pharma A/S




Nykaer 68, 2605 Broendby




DENMARK






Zinacef


750 mg


Powder for Solution for Injection


Intravenous Use


750 mg 6 ml




Estonia







Glaxo Group Ltd,




Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN




UNITED KINGDOM






Zinacef


1,5 g


Powder for solution for injection


Intravenous use, intramuscular use


1,5 g




Estonia







Glaxo Group Ltd, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN




UNITED KINGDOM






Zinacef


750 mg


Powder for solution for injection


Intravenous use, intramuscular use


750 mg




Finland







GlaxoSmithKline Oy




P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, FINLAND






Zinacef


1,5 g


Powder for solution/suspension for injection/infusion


Intravenous Use


1,5 g/15 ml




Finland







GlaxoSmithKline Oy




P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, FINLAND






Zinacef


1,5 g


Powder for solution/suspension for injection/infusion


Intravenous Use


1,5 g/50-100 ml




Finland







GlaxoSmithKline Oy




P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, FINLAND






Zinacef


250 mg


Powder for solution/suspension for injection


Intramuscular Use


250 mg/2 ml




Finland







GlaxoSmithKline Oy




P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, FINLAND






Zinacef


250 mg


Powder for solution/suspension for injection/infusion


Intravenous Use


250 mg/2 ml




Finland







GlaxoSmithKline Oy




P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, FINLAND






Zinacef


750 mg


Powder for solution/suspension for injection


Intramuscular Use


750 mg/3 ml




Finland







GlaxoSmithKline Oy




P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, FINLAND






Zinacef


750 mg


Powder for solution/suspension for injection


Intravenous Use


750 mg/6 ml




France







Laboratoire GlaxoSmithKline




100, route de Versailles – 78163 Marly-le-Roi Cedex




FRANCE






Zinnat


1,5 g


Powder for solution for Infusion


Intravenous Use


1,5 g 50 ml




France







Laboratoire GlaxoSmithKline




100, route de Versailles – 78163 Marly-le-Roi Cedex




FRANCE






Zinnat


250 mg


Powder for solution for Injection


Intravenous Use and Intramuscular use
(Only one MA for 250 mg strength)


250 mg




France







Laboratoire GlaxoSmithKline




100, route de Versailles – 78163 Marly-le-Roi Cedex




FRANCE






Zinnat


750 mg


Powder and solvent for suspension for Injection


Intramuscular Use


750 mg




France







Laboratoire GlaxoSmithKline




100, route de Versailles – 78163 Marly-le-Roi Cedex




FRANCE






Zinnat


750 mg


Powder for solution for Injection


Intravenous Use and Intramuscular use


750 mg




Greece







GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,




152 32 Halandri, Athens




GREECE






Zinacef


1,5 g


Powder for Infusion


Intravenous Use


1,5 g/VIAL




Greece







GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,




152 32 Halandri, Athens




GREECE






Zinacef


250 mg


Powder for Injection


Intravenous Use Intramuscular Use


250 mg/VIAL




Greece







GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,




152 32 Halandri, Athens




GREECE






Zinacef


750 mg


Powder for Injection


Intravenous Use Intramuscular Use


750 mg/VIAL




Hungary







GlaxoSmithKline Kft.




1124 Bp, Csörsz u. 43.




HUNGARY






Zinacef


1,5 g


Powder for Injection


Intravenous Use


1,5 g




Hungary







GlaxoSmithKline Kft.




1124 Bp, Csörsz u. 43.




HUNGARY






Zinacef


250 mg


Solution for injection


Intravenous Use


250 mg + 1 x 2 ml solvent




Hungary







GlaxoSmithKline Kft.




1124 Bp, Csörsz u. 43.




HUNGARY






Zinacef


250 mg


Powder for Injection


Intramuscular Use


250 mg




Hungary







GlaxoSmithKline Kft.




1124 Bp, Csörsz u. 43.




HUNGARY






Zinacef


750 mg


Solution for injection


Intravenous Use


750 mg + 1 x 6 ml solvent




Hungary







GlaxoSmithKline Kft.




1124 Bp, Csörsz u. 43.




HUNGARY






Zinacef


750 mg


Powder for Injection


Intramuscular Use


750 mg




Iceland







GlaxoSmithKline ehf.




Thverholt 14




105 Reykjavík.




ICELAND






Zinacef


1,5 g


Powder for Infusion


Intravenous Use


1,5 g 50 ml




Iceland







GlaxoSmithKline ehf.




Thverholt 14




105 Reykjavík.




ICELAND






Zinacef


1,5 g


Powder for Injection


Intravenous Use


1,5 g 15 ml




Iceland







GlaxoSmithKline ehf.




Thverholt 14




105 Reykjavík.




ICELAND






Zinacef


750 mg


Powder for Infusion


Intramuscular Use


750 mg 3 ml




Iceland







GlaxoSmithKline ehf.




Thverholt 14




105 Reykjavík.




ICELAND






Zinacef


750 mg


Powder for Injection


Intravenous Use


750 mg 6 ml




Ireland







GlaxoSmithKline (Ireland) Limited




Stonemasons Way,




Rathfarnham,




Dublin 16




IRELAND






Zinacef


1,5 g


Powder for injection or solution for infusion


Intravenous Use


1,5 g




Ireland







GlaxoSmithKline (Ireland) Limited




Stonemasons Way,




Rathfarnham,




Dublin 16




IRELAND






Zinacef


250 mg


Powder for solution or suspension for injection


Intravenous or Intramuscular Use


250 mg




Ireland







GlaxoSmithKline (Ireland) Limited




Stonemasons Way,




Rathfarnham,




Dublin 16




IRELAND






Zinacef


750 mg


Powder for solution for injection


Intravenous or IntramuscularUse


750 mg




Italy







GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –




37135 Verona




ITALY






Curoxim


250 mg


Powder and solvent for suspension for Injection


Intramuscular Use


250 mg/ml




Italy







GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –




37135 Verona




ITALY






Curoxim


500 mg


Powder and solvent for suspension for Injection


Intramuscular Use


500 mg/2 ml




Italy







GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –




37135 Verona




ITALY






Curoxim


750 mg


Powder and solvent for suspension for Injection


Intramuscular Use


750 mg/3 ml




Italy







GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –




37135 Verona




ITALY






Curoxim


1 g


Powder and solvent for suspension for Injection


Intravenous Use


1 g/10 ml




Italy







GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –




37135 Verona




ITALY






Curoxim


1 g


Powder and solvent for suspension for Injection


Intramuscular Use


1 g/4 ml




Italy







GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –




37135 Verona




ITALY






Curoxim


2 g


Powder for solution for Infusion


Intravenous Use


2 g




Italy







GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –




37135 Verona




ITALY






Curoxim


1,5 g


Powder for solution for Infusion


Intravenous Use


1,5 g




Italy







GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –




37135 Verona




ITALY






Curoxim


750 mg


Powder for solution for Infusion


Intravenous Use


750 mg




Lithuania







Glaxo Operations UK Limited, Greenford, Middlesex,




UB6 0HE,




UNITED KINGDOM






Zinacef


1,5 g


Powder for Injection


Intravenous Use/Intramuscular Use


 




Lithuania







Glaxo Operations UK Limited, Greenford, Middlesex,




UB6 0HE,




UNITED KINGDOM






Zinacef


250 mg


Powder and Solvant for Solution for Injection


Intravenous Us/Intramuscular Use


 




Lithuania







Glaxo Operations UK Limited, Greenford, Middlesex,




UB6 0HE,




UNITED KINGDOM






Zinacef


750 mg


Powder and Solvant for Solution for Injection


Intravenous Use/Intramuscular Use


 




Luxembourg







GLAXOSMITHKLINE PHARMACEUTICALS SA




2-4-6, AVENUE PASCAL B-1330 WAVRE






Zinacef


1,5 g


Powder for Solution for Infusion


Intravenous Use


1,5 g 50 ml




Luxembourg







GLAXOSMITHKLINE PHARMACEUTICALS SA




2-4-6, AVENUE PASCAL B-1330 WAVRE






Zinacef


1,5 g


Powder for Solution for Injection


Intravenous Use


1,5 g 15 ml




Luxembourg







GLAXOSMITHKLINE PHARMACEUTICALS SA




2-4-6, AVENUE PASCAL B-1330 WAVRE






Zinacef


750 mg


Powder for Solution for Injection


Intravenous Use


750 mg 6 ml




Luxembourg







GLAXOSMITHKLINE PHARMACEUTICALS SA




2-4-6, AVENUE PASCAL B-1330 WAVRE






Zinacef


750 mg


Powder for Solution for Infusion


Intravenous Use


750 mg 50 ml




Luxembourg







GLAXOSMITHKLINE PHARMACEUTICALS SA




2-4-6, AVENUE PASCAL B-1330 WAVRE






Zinacef


750 mg


Powder for Solution for Injection


Intramuscular Use


750 mg 3 ml




Malta







Glaxo Operations UK Limited




Glaxo Wellcome House




Berkeley Avenue




Greenford




Middlesex UB6 0HE




UNITED KINGDOM






Zinacef


250 mg


Powder for suspension for Injection


Intravenous Use


250 mg 2 ml




Malta







Glaxo Operations UK Limited




Glaxo Wellcome House




Berkeley Avenue




Greenford




Middlesex UB6 0HE




UNITED KINGDOM






Zinacef


250 mg


Powder for suspension for Injection


Intramuscular Use


250 mg 1 ml




Malta







Glaxo Operations UK Limited




Glaxo Wellcome House




Berkeley Avenue




Greenford




Middlesex UB6 0HE




UNITED KINGDOM






Zinacef


750 mg


Powder for suspension for Injection


Intravenous Use


750 mg 6 ml




Malta







Glaxo Operations UK Limited




Glaxo Wellcome House




Berkeley Avenue




Greenford




Middlesex UB6 0HE




UNITED KINGDOM






Zinacef


750 mg


Powder for suspension for Injection


Intramuscular Use


750 mg 3 ml




Netherlands







Glaxo Smith Kline B.V.




Huis ter Heideweg 62




3705 LZ ZEIST




NETHERLANDS






Zinacef


1,5 g


Powder for suspension for Injection


Intravenous Use


1,5 g 15 ml




Netherlands







Glaxo Smith Kline B.V.




Huis ter Heideweg 62




3705 LZ ZEIST




NETHERLANDS






Zinacef


1,5 g


Powder for suspension for Infusion


Intravenous Use


1,5 g 100 ml




Netherlands







Glaxo Smith Kline B.V.




Huis ter Heideweg 62




3705 LZ ZEIST




NETHERLANDS






Zinacef


250 mg


Powder for suspension for Injection


Intravenous Use Intrarmuscular Use


250 mg 2 ml (intravenous)
250 mg 1 ml (intramuscular)




Netherlands







Glaxo Smith Kline B.V.




Huis ter Heideweg 62




3705 LZ ZEIST




NETHERLANDS






Zinacef


750 mg


Powder for suspension for Injection


Intravenous Use Intrarmuscular Use


750 mg 6 ml (intravenous)
750 mg 3 ml (intramuscular)




Norway







GlaxoSmithKline AS




Forskningsveien 2A




Postboks 180 Vinderen




0319 Oslo




NORWAY






Zinacef


1,5 g


Powder for Infusion


Intravenous Use


1,5 g 50 ml




Norway







GlaxoSmithKline AS




Forskningsveien 2A




Postboks 180 Vinderen




0319 Oslo




NORWAY






Zinacef


1,5 g


Powder for Injection


Intravenous Use


1,5 g 15 ml




Norway







GlaxoSmithKline AS




Forskningsveien 2A




Postboks 180 Vinderen




0319 Oslo




NORWAY






Zinacef


250 mg


Powder for Injection


Intermuscular Use


250 mg 1 ml




Norway







GlaxoSmithKline AS




Forskningsveien 2A




Postboks 180 Vinderen




0319 Oslo




NORWAY






Zinacef


250 mg


Powder for Injection


Intravenous Use


250 mg 2 ml




Norway







GlaxoSmithKline AS




Forskningsveien 2A




Postboks 180 Vinderen




0319 Oslo




NORWAY






Zinacef


750 mg


Powder for Injection


Intravenous Use


750 mg 6 ml




Norway







GlaxoSmithKline AS




Forskningsveien 2A




Postboks 180 Vinderen




0319 Oslo




NORWAY






Zinacef


750 mg


Powder for Injection


Intermuscular Use


750 mg 3 ml




Poland







GlaxoSmithKline Export Ltd. 980 Great West Road




Brentford, Middlesex, TW8 9GS




UNITED KINGDOM






Zinacef


1,5 g


Powder for solution for injection and infusion


Intravenous Use


1,5 g/15 ml
1,5 g/50-100 ml
1,5 g (Monovial)




Poland







GlaxoSmithKline Export Ltd. 980 Great West Road




Brentford, Middlesex, TW8 9GS




UNITED KINGDOM






Zinacef


750 mg


Powder for suspension for injection or solution for injection and infusion


Intramuscular Use, Intravenous Use


750 mg/3 ml IM
750 mg/6 ml IV
750 mg IV (Monovial)




Portugal







GlaxoWellcome Farmacêutica Lda




Rua Dr António Loureiro Borges no3




Arquiparque – Miraflores




1495-131 Algés




PORTUGAL






Curoxime


750 mg


Powder and solvent for solution for injection


Intravenous Use


750 mg 6 ml




Portugal







GlaxoWellcome Farmacêutica Lda




Rua Dr António Loureiro Borges no3




Arquiparque – Miraflores




1495-131 Algés




PORTUGAL






Curoxime


750 mg


Powder and solvent for solution for injection


Intramuscular Use


750 mg 3 ml




Romania







Glaxo Operations UK Limited, GlaxoSmithKline House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN,




UNITED KINGDOM






Zinacef


750 mg


Powder for Injection


Intravenous Use


750 mg 6 ml




Romania







Glaxo Operations UK Limited, GlaxoSmithKline House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN,




UNITED KINGDOM






Zinacef


750 mg


Powder for Injection


Intramuscular Use


750 mg 3 ml




Slovenia







GSK d.o.o., Ljubljana




Cvetkova ulica 29




SI-1000 Ljubljana




SLOVENIA






Zinacef 1 500 mg prašek za raztopino za injiciranje ali infundiranje


1,5 g


Powder for Solution for injection or Infusion


Intravenous Use


1,5 g 15 ml/
1,5 g 50 ml




Slovenia







GSK d.o.o., Ljubljana Cvetkova ulica 29SI-1000 Ljubljana




SLOVENIA






Zinacef 750 mg prašek za raztopino za injiciranje ali infundiranje


750 mg


Powder for solution for injection or infusion


Intramuscular Use/Intravenous Use


750 mg/3 ml 750 mg 6 ml




Sweden







GlaxoSmithKline AB




Box 516




169 29 Solna




SWEDEN






Zinacef


 


Powder for solution for Infusion


Intravenous Use


 




Sweden







GlaxoSmithKline AB




Box 516




169 29 Solna




SWEDEN






Zinacef


 


Powder for solution for Injection


Intravenous Use


 




Sweden







GlaxoSmithKline AB




Box 516




169 29 Solna




SWEDEN






Zinacef


 


Powder for Solution/Suspension for Injection


Intramuscular Use


 




United Kingdom







Glaxo Operations UK Ltd,




Stockley Park West, Uxbridge, Middlesex, UB11 1BT






Zinacef


1,5 g


Powder for Injection


Intravenous Use and intramuscular use


 




United Kingdom







Glaxo Operations UK Ltd,




Stockley Park West, Uxbridge, Middlesex, UB11 1BT






Zinacef


250 mg


Powder for Injection


Intravenous Use and intramuscular use


 




United Kingdom







Glaxo Operations UK Ltd,




Stockley Park West, Uxbridge, Middlesex, UB11 1BT






Zinacef


750 mg


Powder for Injection


Intravenous Use and intramuscular use


 







ANNEX V

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
EU/EEA


Marketing authorisation holder


Product name


Strength


Pharmaceutical form


Route of administration




Austria







Servier Austria GmbH




Mariahilfer Straße 20/5




Vienna 1070




Austria






Vastarel 35 mg - Filmtabletten mit veränderter Wirkstofffreisetzung


35 mg


Modified-release film-coated tablet


Oral use




Bulgaria







Les Laboratoires Servier,




50, rue Carnot




92284 Suresnes cedex




France






Preductal MR


35 mg


Modified-release tablet


Oral use




Bulgaria







Medica AD




Industrial area




Sandanski 2800




Bulgaria






Prectazidine MR


35 mg


Modified-release tablet


Oral use




Bulgaria







Actavis Group PTC ehf.,




Reykjavikurvegi 76-78




220 Hafnarfjordur




Iceland






Vascotasin


35 mg


Modified-release tablet


Oral use




Bulgaria







ratiopharm GmbH




Graf-Arco-Strasse 3




89079 Ulm




Germany






Trimetazidine-ratiopharm


35 mg


Modified-release tablet


Oral use




Bulgaria







S.C. Labormed Pharma S.A.




44 B, Theodor Pallady, sector 3 Bucharest




Romania






Predozone


20 mg


Coated tablet


Oral use




Bulgaria







Sopharma AD




16 Iliensko shosse str.




1220 Sofia




Bulgaria






Trimductal


20 mg


Film-coated tablet


Oral use




Bulgaria







Mylan S.A.S.




117 Allee des Parcs 69800 Saint Priest




France






Trimetazigen MR


35 mg


Prolonged - release tablet


Oral use




Bulgaria







Glenmark Pharmaceuticals s.r.o.




Hvezdova 1716/2b




Prague 4, 140 78




Czech Republic






Apstar


35 mg


Modified-release tablet


Oral use




Bulgaria







Gedeon Richter Plc.




Gyomroi ut 19-21




H- 1103 Budapest




Hungary






Moduxin MR


35 mg


Prolonged release tablets


Oral use




Bulgaria







Sandoz d.d.




Verovskova 57




1000 Ljubljana




Slovenia






Trimeluzine


35 mg


Modified-release tablet


Oral use




Cyprus







Les Laboratoires Servier




50, rue Carnot




92284 Suresnes cedex




France






VASTAREL 20 mg


20 mg


Film-coated tablet


Oral use




Cyprus







Les Laboratoires Servier




50, rue Carnot




92284 Suresnes cedex




France






VASTAREL


20 mg/ml


Oral drops


Oral use




Cyprus







Les Laboratoires Servier




50, rue Carnot




92284 Suresnes cedex




France






VASTAREL MR


35 mg


Modified-release film-coated tablet


Oral use




Czech Republic







Les Laboratoires Servier




50, rue Carnot




92284 Suresnes cedex




France






PREDUCTAL MR


35 mg


Modified-release tablet


Oral use




Czech Republic







Actavis Group PTC ehf., Hafnarfjördur




Reykjavikurvegur 76-78




220 Hafnarfjördur




Iceland






TRIMETAZIDIN ACTAVIS 35 MG


35 mg


Modified-release tablet


Oral use




Czech Republic







Mylan S.A.S




117 Alleé des Parcs




69 800, Saint-Priest




France






TRIMETAZIDIN MYLAN 35 MG


35 mg


Prolonged-release tablet


Oral use




Czech Republic







SANDOZ s.r.o.




U Nákladového nádraží 10




130 00 Prague




Czech Republic






TRIMETAZIDIN SANDOZ 35 MG


35 mg


Prolonged-release tablet


Oral use




Czech Republic







Glenmark Pharmaceuticals s.r.o




Hvezdova 1716/2b




Prague 4, 140 78




Czech Republic






PORTORA 35 MG TABLETY S PRODLOUŽENÝM UVOLŇOVÁNÍM


35 mg


Prolonged-release tablet


Oral use




Czech Republic







Teva Pharmaceuticals CR, s.r.o.




Radlická 3185/1c




150 00 Prague 5




Czech Republic






TRIMETAZIDIN TEVA RETARD 35 MG


35 mg


Prolonged-release tablet


Oral use




Denmark







Les Laboratoires Servier




50, rue Carnot




92284 Suresnes cedex




France






Vastarel


20 mg


Film-coated tablet


Oral use




Estonia







Les Laboratoires Servier




50, rue Carnot




92284 Suresnes cedex




France






TRIMETAZIDINE MR SERVIER


35 mg


Modified-release tablet


Oral use




Estonia







Les Laboratoires Servier




50, rue Carnot




92284 Suresnes cedex




France






PREDUCTAL MR


35 mg


Modified-release tablet


Oral use




Estonia







Actavis Group PTC ehf Reykjavikurvegi 76-78




220 Hafnarfjördur




Island






TRIMETAZIDINE ACTAVIS


35 mg


Modified-release tablet


Oral use




Estonia







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




The Netherlands






TRIMETAZIDINE TEVA 35 MG


35 mg


Film-coated tablet


Oral use




Estonia







Sandoz d.d.




Verovskova 57




SI-1000 Ljubljana




Slovenia






ZIDMETIN


35 mg


Prolonged-release tablet


Oral use




France







BIOGARAN




15, boulevard Charles de Gaulle




92707 Colombes Cedex




France






TRIMETAZIDINE ALMUS


20 mg


Film-coated tablet


Oral use




France







BIOGARAN




15, boulevard Charles de Gaulle




92707 Colombes Cedex




France






TRIMETAZIDINE BIOGARAN


20 mg


Film-coated tablet


Oral use




France







BIOGARAN




15, boulevard Charles de Gaulle




92707 Colombes Cedex




France






TRIMETAZIDINE BIOGARAN


20 mg/ml


Oral solution


Oral use




France







BIOGARAN




15, boulevard Charles de Gaulle




92707 Colombes Cedex




France






TRIMETAZIDINE BIOGARAN


35 mg


Modified-release film-coated tablet


Oral use




France







CRISTERS




22 quai Gallieni




92150 Suresnes




France






TRIMETAZIDINE CRISTERS


20 mg


Film-coated tablet


Oral use




France







QUALIMED




117, allée des Parcs




69800 Saint-Priest




France






TRIMETAZIDINE QUALIMED


20 mg/ml


Oral drops, solution


Oral use




France







QUALIMED




117, allée des Parcs




69800 Saint-Priest




France






TRIMETAZIDINE QUALIMED


35 mg


Modified-release film-coated tablet


Oral use




France







Les Laboratoires Servier




50, rue Carnot




92284 Suresnes cedex




France






VASTAREL


20 mg


Film-coated tablet


Oral use




France







Les Laboratoires Servier




50, rue Carnot




92284 Suresnes cedex




France






VASTAREL


20 mg/ml


Oral drops, solution


Oral use




France







Les Laboratoires Servier




50, rue Carnot




92284 Suresnes cedex




France






VASTAREL


35 mg


Modified-release film-coated tablet


Oral use




France







VENIPHARM




4, bureaux de la Colline




92213 Saint-Cloud




France






TRANETIZ


35 mg


Modified-release film-coated tablet


Oral use




France







VENIPHARM




4, bureaux de la Colline




92213 Saint-Cloud




France






TRIGEMAX


35 mg


Modified-release film-coated tablet


Oral use




France







BIOGARAN




15, boulevard Charles de Gaulle




92707 Colombes Cedex




France






TRIMETAZIDINE BGR


35 mg


Modified-release film-coated tablet


Oral use




France







CLL PHARMA




Nice Premier - Arénas




455, Promenade des Anglais




06299 Nice Cedex 03 France






TRIMETAZIDINE CLL PHARMA


35 mg


Modified-release film-coated tablet


Oral use




France







SOCIÉTÉ IPSOR GENERIQUES - IGEN




18, avenue des Champs-Elysées




75008 Paris




France






TRIMETAZIDINE IGEN


20 mg/ml


Oral drops, solution


Oral use




France







LABORATOIRES IPSOR




18 Avenue des Champs Elysees




75008 Paris




France






TRIMETAZIDINE IPSOR


20 mg


Film-coated tablet


Oral use




France







LABORATOIRES IPSOR




18 Avenue des Champs Elysees




75008 Paris




France






TRIMETAZIDINE IPSOR


20 mg/ml


Oral drops, solution


Oral use




France







PLUS PHARMACIE SA




26, boulevard Paul Vaillant-Couturier




94200 Ivry-sur-Seine France






TRIMETAZIDINE ISOMED


35 mg


Modified-release film-coated tablet


Oral use




France







CLL PHARMA




Nice Premier - Arénas




455, Promenade des Anglais




06299 Nice Cedex 03 France






TRIMETAZIDINE MILGEN


20 mg


Film-coated tablet


Oral use




France







CLL PHARMA




Nice Premier - Arénas




455, Promenade des Anglais




06299 Nice Cedex 03 France






TRIMETAZIDINE MILGEN


20 mg/ml


Oral drops, solution


Oral use




France







RATIOPHARM GMBH




Graf Arco Strasse 3




89079 Ulm




Germany






TRIMETAZIDINE RATIOPHARM


35 mg


Modified-release film-coated tablet


Oral use




France







SUBSTIPHARM




8, rue Bellini




75116 Paris




France






TRIMETAZIDINE SUBSTIPHARM


20 mg/ml


Oral drops, solution


Oral use




France







ZYDUS FRANCE




25, rue des Peupliers




ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers




92000 Nanterre




France






TRIMETAZIDINE ZYDUS


20 mg


Film-coated tablet


Oral use




France







ZYDUS FRANCE




25, rue des Peupliers




ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers




92000 Nanterre




France






TRIMETAZIDINE ZYDUS


20 mg/ml


Oral solution


Oral use




France







VENIPHARM




4, bureaux de la Colline




92213 Saint-Cloud




France






TRIMEVENI


35 mg


Modified-release film-coated tablet


Oral use




France







TEVA SANTE




Le Palatin 1




1 cours du Triangle




92936 Paris la Défense Cedex




France






TRIMETAZIDINE TEVA


20 mg/ml


Oral solution


Oral use




France







TEVA SANTE




Le Palatin 1




1 cours du Triangle




92936 Paris la Défense Cedex




France






TRIMETAZIDINE TEVA


20 mg


Film-coated tablet


Oral use




France







TEVA SANTE




Le Palatin 1




1 cours du Triangle




9296 Paris la Défense Cedex




France






TRIMETAZIDINE TEVA


35 mg


Modified-release film-coated tablet


Oral use




France







SANOFI AVENTIS FRANCE




1-13, boulevard Romain Rolland




75014 Paris




France






TRIMETAZIDINE WINTHROP


20 mg


Film-coated tablet


Oral use




France







SANOFI AVENTIS FRANCE




1-13, boulevard Romain Rolland




75014 Paris




France






TRIMETAZIDINE WINTHROP


20 mg/ml


Oral solution


Oral use




France







SANOFI AVENTIS FRANCE




1-13, boulevard Romain Rolland




75014 Paris




France






TRIMETAZIDINE WINTHROP


35 mg


Modified-release film coated tablet


Oral use




France







AJC INVEST




6, rue de la Rochefoucauld




16000 Angoulême




France






RIMETAZE


20 mg


Film coated tablet


Oral use




France







AJC INVEST




6, rue de la Rochefoucauld




16000 Angoulême




France






RIMETAZE


20 mg/ml


Oral solution


Oral use




France







MYLAN SAS




117, allée des Parcs




69800 Saint-Priest




France






TRIMETAZIDINE MYLAN


20 mg


Film coated tablet


Oral use




France







MYLAN SAS




117, allée des Parcs




69800 Saint-Priest




France






TRIMETAZIDINE MYLAN


20 mg/ml


Oral solution


Oral use




France







MYLAN SAS




117, allée des Parcs




69800 Saint-Priest




France






TRIMETAZIDINE MYLAN


35 mg


Modified-release film-coated tablet


Oral use




France







SANDOZ




49, avenue Georges Pompidou




92300 Levallois-Perret




France






TRIMETAZIDINE SANDOZ


20 mg


Film coated tablet


Oral use




France







SANDOZ




49, avenue Georges Pompidou




92300 Levallois-Perret




France






TRIMETAZIDINE SANDOZ


20 mg/ml


Oral solution


Oral use




France







ACTAVIS France La Boursidière Centre d'Affaires 92357 Le Plessis Robinson




France






TRIMETAZIDINE ACTAVIS


20 mg


Film coated tablet


Oral use




France







QUALIMED




117, allée des Parcs




69800 Saint-Priest




France






TRIMETAZIDINE QUALIMED


20 mg


Film coated tablet


Oral use




France







PLUS PHARMACIE SA




26, boulevard Paul Vaillant-Couturier




94200 Ivry-sur-Seine




France






TRIMETAZIDINE ISOMED


20 mg


Coated tablet


Oral use




France







EG LABO - LABORATOIRES EUROGENERICS




‘Le Quintet’ - bâtiment A




12, rue Danjou




92517 Boulogne Billancourt Cedex




France






TRIMETAZIDINE EG


20 mg


Film coated tablet


Oral use




France







EG LABO - LABORATOIRES EUROGENERICS




‘Le Quintet’ - bâtiment A




12, rue Danjou




92517 Boulogne Billancourt Cedex




France






TRIMETAZIDINE EG


20 mg/ml


Oral solution


Oral use




France







EG LABO - LABORATOIRES EUROGENERICS




‘Le Quintet’ - bâtiment A




12, rue Danjou




92517 Boulogne Billancourt Cedex




France






TRIMETAZIDINE EG


35 mg


Modified-release film-coated tablet


Oral use




France







ARROW GENERIQUES




26, avenue Tony Garnier




69007 Lyon




France






TRIMETAZIDINE ARROW


20 mg


Film coated tablet


Oral use




France







ARROW GENERIQUES




26, avenue Tony Garnier




69007 Lyon




France






TRIMETAZIDINE ARROW


20 mg/ml


Oral solution


Oral use




France







RATIOPHARM GMBH




Graf Arco Strasse 3




89079 Ulm




Germany






TRIMETAZIDINE RATIOPHARM


20 mg


Coated tablet


Oral use




France







RATIOPHARM GMBH




Graf Arco Strasse 3




89079 Ulm




Germany






TRIMETAZIDINE RATIOPHARM


20 mg/ml


Oral solution


Oral use




France







SANDOZ




49, avenue Georges Pompidou




92300 Levallois-Perret




France






TRIMETAZIDINE SANDOZ


35 mg


modified-release film-coated tablet


Oral use




Germany







ratiopharm GmbH




Graf-Arco-Str. 3




89079 Ulm




Germany






Trimetazidin-ratiopharm 35 mg Retardtabletten


35 mg


Prolonged release tablet


Oral use




Germany







Mepha Investigacao, Desenvolvimento e Fabricacao Farmaceutica, Lda.




Lagoas Park, Edificio 5A, Piso 2




2740-298 Porto Salvo




Portugal






Mephatrim 35 mg Retardtabletten


35 mg


Prolonged release tablet


Oral use




Greece







HELP ABEE, Valaoritou 10




Metamorfosi Attikis 14452




Greece






NOVAZIDINE


20 mg/ml


Oral drops, solution


Oral use




Greece







FOINIXFARM EPE




Dervenakion 38 & Sachini




Gerakas 15344




Greece






ZIDIN


20 mg/ml


Oral drops, solution


Oral use




Greece







SERVIER HELLAS PHARMACEUTICALS Ltd, Ethnikis Antistaseos 72 & Agamemnonos




Greece






VASTAREL


20 mg/tab


Film-coated tablet


Oral use




Greece







SERVIER HELLAS PHARMACEUTICALS Ltd, Ethnikis Antistaseos 72 & Agamemnonos




Greece






VASTAREL


20 mg/ml


Oral drops, solution


Oral use




Greece







SERVIER HELLAS PHARMACEUTICALS Ltd, Ethnikis Antistaseos 72 & Agamemnonos




Greece






VASTAREL


35 mg/tab


Controlled release tablet


Oral use




Hungary







Richter Gedeon nyrt.




Gyömrői út 19-21.




1103 Budapest




Hungary






Moduxin MR


35 mg


Prolonged-release tablet


Oral use




Hungary







Les Laboratoires Servier,




50, rue Carnot




92284 Suresnes cedex




France






Preductal MR


35 mg


Modified-release film-coated tablet


Oral use




Hungary







EGIS Gyógyszergyár nyrt.




Keresztúri út 30-38.




1106 Budapest




Hungary






Adexor MR


35 mg


Modified-release film-coated tablet


Oral use




Hungary







Glenmark Pharmaceuticals s.r.o




Hvezdova 1716/2b




Prague 4, 140 78




Czech Republic






APSTAR 35 mg retard tabletta


35 mg


Prolonged-release tablet


Oral use




Hungary







ratiopharm GmbH




Graf-Arco-Strasse 3




89079 Ulm




Germany






TRIMETAZIDIN- RATIOPHARM 35 mg retard tabletta


35 mg


Prolonged-release tablet


Oral use




Hungary







Mylan S.A.S




117 Allee des Parcs




69800 Saint Priest




France






TRIMETAZIDINE MYLAN 35 mg retard tabletta


35 mg


Prolonged-release tablet


Oral use




Hungary







Actavis Group PTC ehf., Hafnarfjördur




Reykjavikurvegur 76-78




220 Hafnarfjördur




Iceland






VASCOTASIN 35 mg módosított hatóanyagleadású tabletta


35 mg


modified release tablet


Oral use




Hungary







Sandoz Hungária Kft.




1114 Budapest




Bartók Béla út 43-47.




Magyarország




Hungary






TRIMETAZIDINE SANDOZ 35 mg retard tabletta


35 mg


Prolonged-release tablet


Oral use




Ireland







Servier Laboratories (Ireland) Ltd




First Floor, Block 2




West Pier BusinessCampus




Old Dunleary Road,




Dun Laoghaire




Dublin




Ireland






Vastarel


20 mg


Film-coated tablet


Oral use




Ireland







Servier Laboratories (Ireland) Ltd




First Floor, Block 2




West Pier BusinessCampus




Old Dunleary Road,




Dun Laoghaire




Dublin




Ireland






Trimetazidine


35 mg


Prolonged-release film-coated tablet


Oral use




Ireland







Servier Laboratories (Ireland) Ltd




First Floor, Block 2




West Pier BusinessCampus




Old Dunleary Road,




Dun Laoghaire




Dublin




Ireland






Vastarel


35 mg


Prolonged-release film-coated tablet


Oral use




Italy







Istituto Farmaco Biologico Stroder S.R.L.




Via di Ripoli, 207V - 50126 Firenze




Italy






VASTAREL


20 mg


Coated tablet


Oral use




Latvia







Gedeon Richter Plc.




H-1103 Budapest




Gyömrői út 19-21




Hungary






Moduxin 35 mg ilgstošās darbības tabletes


35 mg


Prolonged-release tablet


Oral use




Latvia







Actavis Group PTC ehf., Reykjavikurvegi 76-78,




220 Hafnarfjorður




Iceland






Trimetazidine Actavis 35 mg ilgstošās darbības tabletes


35 mg


Modified-release tablet


Oral use




Latvia







Les Laboratoires Servier




50, rue Carnot




92284 Suresnes cedex




France






Preductal MR 35 mg ilgstošās darbības apvalkotās tabletes


35 mg


Modified-release tablet


Oral use




Latvia







Les Laboratoires Servier




50, rue Carnot




92284 Suresnes cedex




France






Trimetazidine MR Servier 35 mg ilgstošās darbības apvalkotās tabletes


35 mg


Modified-release tablet


Oral use




Latvia







Teva Pharma B.V.




Computerweg 10, 3542 DR Ultrecht




The Netherlands






Trimetazidine Teva 35 mg ilgstošās darbības tabletes


35 mg


Prolonged-release tablet


Oral use




Latvia







Sandoz d.d




Verovskova 57,




SI-1000 Ljubljana




Slovenia






Zidmetin 35 mg ilgstošās darbības tabletes


35 mg


Modified-release tablet


Oral use




Lithuania







Sandoz d.d




Verovskova 57,




SI-1000 Ljubljana




Slovenia






Zidmetin


35 mg


Prolonged-release tablet


Oral use




Lithuania







Les Laboratoires Servier,




50, rue Carnot




92284 Suresnes cedex




France






Preductal MR


35 mg


Modified-release film-coated tablet tablet


Oral use




Lithuania







Les Laboratoires Servier,




50, rue Carnot




92284 Suresnes cedex




France






Trimetazidine MR Servier


35 mg


Modified-release film-coated tablet tablet


Oral use




Lithuania







Teva Pharma B.V.




Computerweg 10 3542 DR Ultrecht




The Netherlands






Trimetazidine-Teva


35 mg


Prolonged-release tablet


Oral use




Lithuania







Actavis Group PTC ehf., Reykjavikurvegi 76-78




220 Hafnarfjorður




Iceland






Trimetazidine Actavis


35 mg


Modified-release tablet


Oral use




Luxembourg







Les Laboratoires Servier,




50, rue Carnot




92284 Suresnes cedex




France






Vastarel-20


20 mg


Coated tablet


Oral use




Luxembourg







Les Laboratoires Servier,




50, rue Carnot




92284 Suresnes cedex




France






Vastarel


20 mg/ml


Drops


Oral use




Luxembourg







Les Laboratoires Servier




50, rue Carnot




92284 Suresnes cedex




France






Vastarel-35


35 mg


Prolonged-release tablet


Oral use




Malta







Les Laboratoires Servier,




50, rue Carnot




92284 Suresnes cedex




France






VASTAREL 20 mg


20 mg


Film-coated tablet


Oral use




Malta







Les Laboratoires Servier,




50, rue Carnot




92284 Suresnes cedex




France






VASTAREL MR


35 mg


Modified release film coated tablet


Oral use




Poland







Ethifarm Sp. z o. o.




ul. Hiacyntowa 39




60-175 Poznań




Poland






Cyto-Protectin MR


35 mg


Prolonged-release tablet


Oral use




Poland







Przedsiębiorstwo Farmaceutyczne




LEK-AM Sp. z o.o.




Ostrzykowizna 14A




05-170 Zakroczym




Poland






Trimeductan MR


35 mg


Prolonged-release tablet


Oral use




Poland







Pabianickie Zakłady Farmaceutyczne Polfa S.A.




Marszałka J. Piłsudskiego 5, 95-200 Pabianice




Poland






Metazydyna


20 mg


Film-coated tablet


Oral use




Poland







Les Laboratoires Servier,




50, rue Carnot




92284 Suresnes cedex




France






Preductal


20 mg


Film-coated tablet


Oral use




Poland







ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.




ul. Annopol 6B




03-236 Warszawa




Poland






Preductal MR


35 mg


Modified-release film-coated tablet


Oral use




Poland







Gedeon Richter Polska Sp. z o.o.




Graniczna str. 35




05-825 Grodzisk Mazowiecki




Poland






Protevasc SR


35 mg


Modified-release film-coated tablet


Oral use




Poland







ratiopharm GmbH




Graf-Arco-Strasse 3




Ulm, 89079




Germany






Trimetaratio


20 mg


Film-coated tablet


Oral use




Poland







ratiopharm GmbH




Graf-Arco-Strasse 3




Ulm, 89079




Germany






Trimetazidine-ratiopharm PR


35 mg


Prolonged-release tablet


Oral use




Poland







Ethifarm Sp. z o. o.




ul. Hiacyntowa 39




60-175 Poznań




Poland






Cyto-Protectin MR


35 mg


Prolonged-release tablet


Oral use




Poland







Glenmark Pharmaceuticals s.r.o.




Hvezdova 1716/2b




Praga 4




CZ-140 78




Czech Republic






Portora


35 mg


Prolonged-release tablet


Oral use




Poland







Zentiva, k.s.




U kabelovny 130




Praga 10, Dolni Mecholupy




10237 Dolni Mecholupy




Czech Republic






Trimedal


35 mg


Prolonged-release tablet


Oral use




Poland







Sandoz GmbH




Biochemiestrasse 10




A-6250 Kundl




Austria






Dimesar


35 mg


Prolonged-release tablet


Oral use




Portugal


Servier Portugal - Especialidades Farmacêuticas, Lda. Av. António Augusto de Aguiar, 128 1069-133 Lisboa Portugal


Vastarel


20 mg


Coated tablets


Oral use




Portugal


Servier Portugal - Especialidades Farmacêuticas, Lda. Av. António Augusto de Aguiar, 128 1069-133 Lisboa Portugal


Vastarel


20 mg/ml


Oral solution


Oral use




Portugal


Sanofi-Aventis - Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park, Edifício 7 - 3o Piso 2740-244 Porto Salvo Portugal


Trimetazidina Zentiva


20 mg


Coated tablets


Oral use




Portugal


Labesfal - Laboratórios Almiro, S.A. Zona Industrial do Lagedo 3465-157 Santiago de Besteiros Portugal


Trimetazidina Labesfal 20 mg Comprimidos Revestidos


20 mg


Coated tablets


Oral use




Portugal


Mylan, Lda. Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqo 1499-016 Algés Portugal


Trimetazidina Mylan


20 mg


Coated tablets


Oral use




Portugal


Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal


Trimetazidina Generis 20 mg Comprimidos Revestidos


20 mg


Coated tablets


Oral use




Portugal


Servier Portugal - Especialidades Farmacêuticas, Lda. Av. António Augusto de Aguiar, 128 1069-133 Lisboa Portugal


Vastarel LM


35 mg


Modified-release tablet


Oral use




Portugal


Bluepharma Genéricos - Comércio de Medicamentos, S.A. São Martinho do Bispo 3045-016 Coimbra Portugal


Trimetazidina Bluepharma 20 mg Comprimidos


20 mg


Coated tablets


Oral use




Portugal


Vida - Produtos Farmacêuticos, S.A. Rua da Estação, 42 - Vala do Carregado 2600-726 Castanheira do Ribatejo Portugal


Trimetazidina Vida


20 mg


Coated tablets


Oral use




Portugal


Helm Portugal, Lda. Estrada Nacional n.o 10, Km 140, 260 2695-066 Bobadela - Loures Portugal


Trimetazidina Baldacci 20 mg Comprimidos


20 mg


Coated tablets


Oral use




Portugal


Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park, Edifício 5 A - Piso 2 2740-298 Porto Salvo Portugal


Trimetazidina Mepha 20 mg Comprimidos Revestidos


20 mg


Coated tablets


Oral use




Portugal


Jaba Recordati, S. A. Lagoas Park, Edificio 5, Torre C, Piso 3 2740-298 Porto Salvo Portugal


Trimetazidina Jaba 20 mg Comprimidos revestidos


20 mg


Coated tablets


Oral use




Portugal


Teva Pharma - Produtos Farmacêuticos, Lda Lagoas Park, Edifício 1 - 3o 2740-264 Porto Salvo Portugal


Trimetazidina Teva


20 mg


Coated tablets


Oral use




Portugal







Les Laboratoires Servier




50, rue Carnot




92284 Suresnes cedex




France






Tacirel LM


35 mg


Modified-release tablet


Oral use




Portugal


Cinfa Portugal, Lda. Av.Tomás Ribeiro, 43 - Bloco 1, 4o B - Edifício Neopark 2790-221 Carnaxide Portugal


Trimetazidina Cinfa 20 mg Comprimidos revestidos por película


20 mg


Film-coated tablets


Oral use




Portugal


Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. Rua Quinta do Pinheiro - Edifício Tejo - 6o Piso 2790-143 Carnaxide Portugal


Trimetazidina Ratiopharm


20 mg


Film-coated tablets


Oral use




Portugal


Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. Rua Quinta do Pinheiro - Edifício Tejo - 6o Piso 2790-143 Carnaxide Portugal


Trimetazidina Ratiopharm


35 mg


Prolonged-release tablets


Oral use




Portugal


Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal


Trimetazidina Generis


35 mg


Prolonged-release tablets


Oral use




Portugal


Teva Pharma - Produtos Farmacêuticos, Lda Lagoas Park, Edifício 1 - 3o 2740-264 Porto Salvo Portugal


Trimetazidina Teva


35 mg


Prolonged-release tablets


Oral use




Portugal


Labesfal - Laboratórios Almiro, S.A. Zona Industrial do Lagedo 3465-157 Santiago de Besteiros Portugal


Trimetazidina Labesfal


35 mg


Prolonged-release tablets


Oral use




Portugal


Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2o - Escritório 15 2710-693 Sintra Portugal


Trimetazidina Sandoz


35 mg


Prolonged-release tablets


Oral use




Portugal


Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park, Edifício 5 A - Piso 2 2740-298 Porto Salvo Portugal


Trimetazidina Mepha LP


35 mg


Prolonged-release tablets


Oral use




Portugal


Bluepharma Genéricos - Comércio de Medicamentos, S.A. São Martinho do Bispo 3045-016 Coimbra Portugal


Trimetazidina Bluepharma LP


35 mg


Prolonged-release tablets


Oral use




Portugal


Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2o - Escritório 15 2710-693 Sintra Portugal


Trimetazidina Itraxel


35 mg


Prolonged-release tablets


Oral use




Portugal







Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.o 11 - 3o, Sala 31 - Miraflores




1495-139 Algés




Portugal






Lupamadazine


35 mg


Prolonged-release tablets


Oral use




Portugal


Mylan, Lda. Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqo 1499-016 Algés Portugal


Trimetazidina Mylan


35 mg


Prolonged-release tablets


Oral use




Portugal


Sanofi-Aventis - Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park, Edifício 7 - 3o Piso 2740-244 Porto Salvo Portugal


Zilutra


35 mg


Prolonged-release tablets


Oral use




Romania







MYLAN S.A.S.




117, Allée des Parcs




69800 Saint Priest




France






Trimetazidina Mylan


35 mg


Prolonged-release tablet


Oral use




Romania







S.C. TERAPIA S.A.




Str. Fabricii nr. 124




Cluj Napoca




România






DILATAN MR 35 mg, comprimate filmate cu eliberare modificată, 35 mg


35 mg


Prolonged-release tablet


Oral use




Romania







S.C. TERAPIA S.A.




Str. Fabricii nr. 124




Cluj Napoca




România






DILATAN 20 mg, comprimate filmate, 20 mg


20 mg


Film-coated tablet


Oral use




Romania







S.C. VIM SPECTRUM S.R.L., Șos. Sighișoarei nr. 409, Sat Corunca, Com. Livezeni




Jud. Mureș




România






TRIMETAZIDIN VIM SPECTRUM 20 mg, capsule


20 mg


Capsule


Oral use




Romania







Les Laboratoires Servier,




50, rue Carnot




92284 Suresnes cedex




France






PREDUCTAL MR 35 mg, comprimate filmate cu eliberare modificată


35 mg


Modified-release tablet


Oral use




Romania







Les Laboratoires Servier,




50, rue Carnot




92284 Suresnes cedex




France






PREDUCTAL 20 mg, comprimate filmate


20 mg


Film-coated tablet


Oral use




Romania







GEDEON RICHTER




ROMÂNIA S. A.




Str. Cuza - Vodă nr. 99 – 105




Târgu – Mureș




România






MODUXIN MR 35 mg, comprimate filmate cu eliberare prelungită


35 mg


Prolonged-release tablet


Oral use




Romania







GEDEON RICHTER




ROMÂNIA S. A.




Str. Cuza - Vodă nr. 99 – 105




Târgu – Mureș




România






MODUXIN 20 mg, comprimate filmate


20 mg


Film-coated tablet


Oral use




Romania







S.C. TERAPIA S.A.




Str. Fabricii nr. 124




Cluj Napoca




România






TRIMETAZIDINA 20 mg, drajeuri


20 mg


Coated tablet


Oral use




Romania







LABORMED PHARMA S.A. Bd. Theodor Pallady nr. 44B




sector 3, București




România






TRIMETAZIDINĂ LPH 35 mg, comprimate filmate cu eliberare modificată


35 mg


Modified-release tablet


Oral use




Romania







LABORMED PHARMA S.A. Bd. Theodor Pallady nr. 44B




sector 3, București




România






TRIMETAZIDINĂ LPH 20 mg, comprimate filmate


20 mg


Film-coated tablet


Oral use




Romania







LABORMED PHARMA S.A.




Bd. Theodor Pallady nr. 44B




sector 3, București




România






Oxcardin 20 mg, comprimate filmate


20 mg


Film-coated tablet


Oral use




Romania







LABORMED PHARMA S.A.




Bd. Theodor Pallady nr. 44B




sector 3, București




România






Oxcardin MR 35 mg, comprimate filmate cu eliberare modificată


35 mg


Modified-release tablet


Oral use




Romania







GLENMARK PHARMACEUTICALS s.r.o.




Hvezdova 1716/2b, Prague 4, 140 78




Czech Republic






APSTAR 35 mg comprimate cu eliberare prelungită


35 mg


Prolonged-release tablet


Oral use




Romania







S.C.SANDOZ S.R.L.




Str. Livezeni nr. 7A




540472 Târgu Mureș




România






TRIMELUZINE 35 mg comprimate cu eliberare prelungită


35 mg


Prolonged-release tablet


Oral use




Slovak Republic







ratiopharm GmbH




Graf-Arco-Strasse 3




89079 Ulm




Germany






Trimetazidin-ratiopharm 20 mg


20 mg


Film-coated tablet


Oral use




Slovak Republic







ratiopharm GmbH




Graf-Arco-Strasse 3




89079 Ulm




Germany






Trimetazidin ratiopharm retard 35 mg


35 mg


Modified-release film-coated tablet


Oral use




Slovak Republic







PRO.MED.CS PRAHA a.s. Telčská 1




140 00 Praha




Czech Republic






Angitrim


20 mg


Film-coated tablet


Oral use




Slovak Republic







EGIS Pharmaceuticals PLC




Keresztúri út 30-38, 1106 Budapest




Hungary






Adexor


20 mg


Film-coated tablet


Oral use




Slovak Republic







Les Laboratoires Servier,




50, rue Carnot




92284 Suresnes cedex




France






PREDUCTAL MR


35 mg


Modified-release film-coated tablet


Oral use




Slovak Republic







Mylan S.A.S




117, Allée des Parcs




69800 Saint Priest




France






Trimetazidin Mylan 35 mg


35 mg


Prolonged-release tablet


Oral use




Slovak Republic







Deml Group s.r.o.




Jeneweinova 51a




617 00 Brno




Czech Republic






Trimetazidin - DemlGroup PR 35 mg


35 mg


Prolonged-release film-coated tablet


Oral use




Slovak Republic







Actavis Group PTC ehf Reykjavkurvegi 76-78




220 Hafnarfiroi




Iceland






Vascotazin 35 mg


35 mg


Modified-release tablet


Oral use




Slovak Republic







Glenmark Pharmaceuticals s.r.o.




Hvezdova 1716/2b 140 78 Praha 4




Czech Republic






Apstar 35 mg tablety s predĺženým uvoľňovaním


35 mg


Prolonged-release tablet


Oral use




Slovenia







Servier Pharma d.o.o.




Pot k sejmiscu 33




SI-1231 Ljubljana Crnuce




Slovenia






PREDUCTAL MR 35 mg filmsko oblozene tablete s prirejenim sproscanjem


35 mg


Modified-release film-coated tablet


Oral use




Slovenia







Servier Pharma d.o.o.




Pot k sejmiscu 33




SI-1231 Ljubljana Crnuce




Slovenia






TRIMETAZIDIN SERVIER 35 mg filmsko obložene tablete s prirejenim sproščanjem


35 mg


Modified-release film-coated tablet


Oral use




Spain







LABORATORIOS DAVUR, S.L.




C/Teide, 4- planta baja




Polígono Empresarial La Marina




28703 San Sebastian de los Reyes (MADRID)




Spain






TRIMETAZIDINA DAVUR 20 mg comprimidos recubiertos EFG


20 mg


Film-coated tablet


Oral use




Spain







RIMAFAR, S.L.




Polígono Industrial Malpica Calle C, No 4




50016 ZARAGOZA




Spain






TRIMETAZIDINA RIMAFAR 20 mg comprimidos recubiertos EFG


20 mg


Film-coated tablet


Oral use




Spain







RATIOPHARM ESPAÑA, S.A. Avda. Burgos, 16 D-5a planta




28036 MADRID




Spain






TRIMETAZIDINA RATIOPHARM 20 mg comprimidos recubiertos con película EFG


20 mg


Film-coated tablet


Oral use




Spain







DANVAL, S.A.




Avda. de los Madroños, 33




28043 Madrid




Spain






IDAPTAN 20 mg comprimidos recubiertos con película


20 mg


Film-coated tablet


Oral use




Spain







DANVAL, S.A.




Avda. de los Madroños, 33




28043 Madrid




Spain






IDAPTAN 20 mg/ml solución oral


20 mg/ml


Oral solution


Oral use




Spain







LABORATORIOS CINFA, S.A.




C/Olaz-Chipi, 10




Polígono Industrial Areta




31620 Huarte (PAMPLONA)




Spain






TRIMETAZIDINA CINFA 20 mg comprimidos recubiertos con película EFG


20 mg


Film-coated tablet


Oral use




Spain







PENSA PHARMA, S.A.U.




C/Jorge Comín (Médico Pediatra)




3-bajos




46015 Valencia




Spain






TRIMETAZIDINA PENSA 20 mg comprimidos recubiertos con película EFG


20 mg


Film-coated tablet


Oral use