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Flupirtine: PRAC recommends revoking the marketing authorisation of the painkiller Flupirtine

Date 2018.02.09
Active substance flupirtine

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