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Flupirtine: Implementation of revocation of marketing authorisation

Date 2018.05.24
Active substance flupirtine

24.05.2018 - Implementation of the CMDh position through a national graduated plan procedure (Stufenplanverfahren)

In its notices and/or ascertainment decision of 26 April 2018, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the unanimous CMDh position of 21 March 2018.

23.03.2018 - CMDh position

The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has confirmed the recommendation of the European Medicines Agency (EMA) to revoke the marketing authorisation of the pain medicine flupirtine due to the risk of serious liver injury.

09.02.2018 - PRAC recommendation

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended revoking the marketing authorisations of painkillers containing flupirtine.

27.10.2017 - Procedure started

The European Medicines Agency (EMA) has again initiated a review procedure regarding medicinal products containing flupirtine for pain relief. The medicinal products are still being administered without sufficient consideration of the restrictions introduced and cases of serious liver damage have continued to be reported.

To the risk assessment procedure (available in German only)

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

Flupirtine-containing medicines