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31 May 2017 EMA/701561/2013 CORRECTION 4* Patient Health Protection

List of trimetazidine containing medicinal products in the European Union Name of the product

Marketing Authorisation Holder

Country where product is authorised

Adexor

EGIS Pharmaceuticals PLC

Slovak Republic

Angitrim

PRO.MED.CS Praha a.s.

Slovak Republic

Apstar

Glenmark Pharmaceuticals s.r.o.

Bulgaria

Apstar 35 mg Comprimate Cu Eliberare Prelungită

Glenmark Pharmaceuticals s.r.o.

Romania

Apstar 35 mg Retard Tabletta

Glenmark Pharmaceuticals s.r.o.

Hungary

Apstar 35 mg Tablety S Predĺženým Uvoľňovaním

Glenmark Pharmaceuticals s.r.o.

Slovak Republic

Cyto-Protectin MR

Ethifarm Sp. z o.o.

Poland

Cyto-Protectin MR

Ethifarm Sp. z o.o.

Poland

Dilatan 20 mg, Comprimate Filmate, 20 mg

S.C. Terapia S.A.

Romania

Dilatan MR 35 mg, Comprimate Filmate Cu Eliberare Modificată, 35 mg

S.C. Terapia S.A.

Romania

Lupamadazine

Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda.

Portugal

Metazydyna

Pabianickie Zakłady Farmaceutyczne Polfa S.A.

Poland

Novazidine

Help Abee

Greece

Oxcardin 20 mg, Comprimate Filmate

Labormed Pharma S.A.

Romania

Oxcardin MR 35mg, Comprimate Filmate Cu Eliberare Modificată

Labormed Pharma S.A.

Romania

Portora

Glenmark Pharmaceuticals s.r.o.

Poland

Portora 35 mg Tablety S Prodlouženým Uvolňováním

Glenmark Pharmaceuticals s.r.o.

Czech Republic

Prectazidine MR

Medica AD

Bulgaria

Preductal

Les Laboratoires Servier

Poland

Rimetaze 20 mg

AJC Invest

France

Rimetaze 20 mg/ml

AJC Invest

France

Tranetiz

Venipharm

France

Trigemax

Venipharm

France

Trimductal

Sopharma AD

Bulgaria

Trimedal**

Zentiva, k.s.

Poland

Trimeductan MR

Przedsiębiorstwo Farmaceutyczne

Poland

Trimeluzine

Sandoz d.d.

Bulgaria

Trimetazidin Sandoz 35 mg

Sandoz s.r.o.

Czech Republic

Trimetazidin Servier 35 mg Filmsko Obložene Tablete S Prirejenim Sproščanjem

Servier Pharma d.o.o.

Slovenia

Trimetazidin Vim Spectrum 20 mg, Capsule

S.C. Vim Spectrum S.R.L.

Romania

Trimetazidina 20 mg, Drajeuri

S.C. Terapia S.A.

Romania

Trimetazidina Baldacci 20 mg Comprimidos

Helm Portugal, Lda.

Portugal

Trimetazidina Bluepharma 20 mg Comprimidos

Bluepharma Genéricos - Comércio de Medicamentos, S.A.

Portugal

Trimetazidina Bluepharma LP

Bluepharma Genéricos - Comércio de Medicamentos, S.A.

Portugal

Trimetazidina Itraxel

Sandoz Farmacêutica, Lda.

Portugal

Trimetazidina Jaba 20 mg Comprimidos Revestidos

Jaba Recordati, S.A.

Portugal Page 1

Name of the product

Marketing Authorisation Holder

Country where product is authorised

Trimetazidina Mepha LP

Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Portugal

Trimetazidina Vida

Vida - Produtos Farmacêuticos, S.A.

Portugal

Trimetazidina Zentiva

Sanofi-Aventis - Produtos Farmacêuticos, Lda.

Portugal

Trimetazidine

Servier Laboratories (Ireland) Ltd

Ireland

Trimetazidine - Ratiopharm

Ratiopharm GmbH

Bulgaria

Trimetazidine - Ratiopharm PR

Ratiopharm GmbH

Poland

Trimetazidine Actavis

Actavis France

France

Trimetazidine Almus

Biogaran

France

Trimetazidine Arrow 20 mg

Arrow Generiques

France

Trimetazidine Arrow 20 mg/ml

Arrow Generiques

France

Trimetazidine CLL Pharma

CLL Pharma

France

Trimetazidine Cristers

Cristers

France

Trimetazidine EG 20 mg

EG Labo - Laboratoires Eurogenerics

France

Trimetazidine EG 20 mg/ml

EG Labo - Laboratoires Eurogenerics

France

Trimetazidine EG 35 mg

EG Labo - Laboratoires Eurogenerics

France

Trimetazidine IGEN

Société Ipsor Generiques - IGEN

France

Trimetazidine Ipsor 20 mg

Laboratoires Ipsor

France

Trimetazidine Ipsor 20 mg/ml

Laboratoires Ipsor

France

Trimetazidine Isomed

Plus Pharmacie SA

France

Trimetazidine Isomed

Plus Pharmacie SA

France

Trimetazidine Milgen 20 mg

CLL Pharma

France

Trimetazidine Milgen 20 mg/ml

CLL Pharma

France

Trimetazidine Qualimed

Qualimed

France

Trimetazidine Qualimed 20 mg/ml

Qualimed

France

Trimetazidine Qualimed 35 mg

Qualimed

France

Trimetazidine Ratiopharm

Ratiopharm GmbH

France

Trimetazidine Ratiopharm 20 mg

Ratiopharm GmbH

France

Trimetazidine Ratiopharm 20 mg/ml

Ratiopharm GmbH

France

Trimetazidine Sandoz

Sandoz

France

Trimetazidine Sandoz 20 mg

Sandoz

France

Trimetazidine Sandoz 20 mg/ml

Sandoz

France

Trimetazidine Substipharm

Substipharm

France

Trimetazidine Teva 20 mg

Teva Sante

France

Trimetazidine Teva 35 mg

Teva Sante

France

Trimetazidine Winthrop 20 mg

Sanofi Aventis France

France

Trimetazidine Winthrop 20 mg/ml

Sanofi Aventis France

France

Trimetazidine Winthrop 35 mg**

Sanofi Aventis France

France

Trimetazidine Zydus 20 mg

Zydus France

France

Trimetazidine Zydus 20 mg/ml

Zydus France

France

Trimeveni

Venipharm

France

Vastarel

Les Laboratoires Servier

Cyprus Page 2

Name of the product

Marketing Authorisation Holder

Country where product is authorised

Vastarel

Les Laboratoires Servier

Denmark

Vastarel

Les Laboratoires Servier

Luxembourg

Vastarel MR

Les Laboratoires Servier

Cyprus

Vastarel MR

Les Laboratoires Servier

Malta

Zidin

Foinixfarm EPE

Greece

Zidmetin

Sandoz d.d

Lithuania

Zilutra**

Sanofi-Aventis - Produtos Farmacêuticos, Lda.

Portugal

*This annex was previously amended on 26 April 2017. ** These products were withdrawn, hence they have been removed from the list.

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