27 September 2017 EMA/68528/2014 CORRECTION 4* Patient Health Protection

List of flupirtine-containing medicinal products in the European Union Name of the product

Marketing Authorisation Holder

Country where product is authorised

Katadolon

Teva Pharma B.V.

Estonia

Flupirtinmaleat AbZ 100 mg Kapseln

AbZ-Pharma GmbH

Germany

Flupirtinmaleat AL 100 mg Hartkapseln

Aliud Pharma GmbH

Germany

Awegal inject

AWD.pharma GmbH & Co. KG

Germany

Katadolon inject

AWD.pharma GmbH & Co. KG

Germany

Katadolon Kinderzäpfchen

AWD.pharma GmbH & Co. KG

Germany

Katadolon Zäpfchen

AWD.pharma GmbH & Co. KG

Germany

Trancopal Dolo

AWD.pharma GmbH & Co. KG

Germany

Trancopal Dolo Suppositorien

AWD.pharma GmbH & Co. KG

Germany

Katadolon S long

AWD.pharma GmbH & Co. KG

Germany

Katadolon

AWD.pharma GmbH & Co. KG

Germany

Trancolong

AWD.pharma GmbH & Co. KG

Germany

Katadolon retard

AWD.pharma GmbH & Co. KG

Germany

Flupirtinmaleat Winthrop 400 mg Retardtabletten

AWD.pharma GmbH & Co. KG

Germany

Flupirtinmaleat-CT 100 mg Hartkapsel

CT Arzneimittel GmmbH

Germany

Flupin 100 mg Hartkapseln

CT Arzneimittel GmmbH

Germany

Dolokadin einmal täglich

Dr. Kade Pharmazeutische

Germany

Flupigamma 100 mg Hartkapseln

Hormosan Pharma GmbH

Germany

Flupirtinmaleat-Hormosan 100 mg Hartkapseln

Hormosan Pharma GmbH

Germany

Flupigil 100 mg Hartkapseln

MEDA Pharma GmbH & Co. KG

Germany

Flupigil 100 mg Hartkapseln

MEDA Pharma GmbH & Co. KG

Germany

Flupirtinmaleat Midas 100 mg Hartkapseln

Midas Pharma GmbH

Germany

Flupirtinmaleat-ratiopharm 100 mg Hartkapsel

ratiopharm GmbH

Germany

Miflumal 100 mg Hartkapseln

ratiopharm GmbH

Germany

Flupirtinmaleat Vitapharma 100 mg Hartkapseln

Vitapharma Generics GmbH

Germany

Flupivil 100 mg Hartkapseln

Vitapharma Generics GmbH

Germany

Flupirtinmaleat Viatris 100 mg Hartkapseln

Vitapharma Generics GmbH

Germany

Flupirtinmaleat Winthrop 100 mg Hartkapseln

Winthrop Arzneimittel GmbH

Germany

Efiret **

MEDA PHARMA S.p.A.

Italy

Katadolon 100 mg hard capsules

Teva Pharma B.V.

Latvia

Katadolon

Teva Pharma B.V.

Lithuania

Katadolon

Teva Pharmaceuticals Polska Sp. z o.o.

Poland

Metanor

Meda Pharma - Produtos Farmacêuticos, S.A.

Portugal

Katadolon

TEVA Pharmaceuticals

Slovak Republic

* This annex was previously amended on 28 June 2017. ** The marketing authorisation of Efiret has been withdrawn, therefore it has been removed from this list.

Page 1

Flupirtine-containing medicinal products - European Medicines Agency

Name of the product. Marketing Authorisation Holder. Country where product is authorised. Katadolon. Teva Pharma B.V.. Estonia. Flupirtinmaleat AbZ 100 mg Kapseln. AbZ-Pharma GmbH. Germany. Flupirtinmaleat AL 100 mg Hartkapseln. Aliud Pharma GmbH. Germany. Awegal inject. AWD.pharma GmbH & Co. KG.

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