Name of the product. Marketing Authorisation Holder. Country where product is authorised. Katadolon. Teva Pharma B.V.. E
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 ** The marketing authorisation of Efiret has been withdrawn, therefore it has been removed from this list.
