BfArM - Federal Institute for Drugs and Medical Devices

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Flupirtine: restrictions in the use of flupirtine-containing medicines

Active substance: flupirtine

27.01.2014 - Notice within the graduated plan procedure ("Stufenplanverfahren")

In its notice of 18 December 2013, the Federal Institute for Drugs and Medical Devices has ruled the realisation of the implementing decision of the European Commission regarding medicinal products with the active substance flupirtine.

17.06.2013 - PRAC recommendation

The European Medicines Agency has concluded its review of medicinal products containing flupirtine and recommends restrictions in their use.

15.03.2013 - Procedure started

The European Medicines Agency (EMA) has initiated a review procedure regarding flupirtine. The procedure is based on a corresponding application by the BfArM.

Further Information

For details regarding the procedure please click on the following link to the European Medicines Agency (EMA):

Flupirtine-containing medicines

To the risk assessment procedure (available in German only)