08.02.2023 - Realisation of the EU Commission's implementing decision

Following the recommendation of the Coordination Group on Mutual Recognition Procedures and Decentralised Procedures - Human (CMDh) on the revocation of marketing authorisations and prior to the final decision of the European Commission, all marketing authorisation holders of medicinal products containing amfepramone in Germany have declared a voluntary surrender of their marketing authorisations as of 01 December 2022.

19.01.2023 - European Commission final decision

The European Commission made its final legally binding decision on January 13, 2023, resulting in the revocation of national authorizations. This decision, addressed to the EU member states, is valid in all EU member states. This concludes the European risk assessment procedure under Article 31 of Directive 2001/83/EC on medicinal products containing amfepramone.

11.11.2022 - CMDh position

EMA's Co-Ordination Group confirms recommendation to withdraw marketing authorizations of amfepramone-containing drugs

Concerning the risk evaluation for Amfepramon, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) agreed with the PRAC recommendation and adopted its position by majority on 10 November 2022.

28.10.2022 - PRAC recommendation after re-examination

EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines

EMA’s safety committee (PRAC) has confirmed its recommendation to withdraw the marketing authorisations for amfepramone obesity medicines. This follows a re-examination of its previous recommendation of June 2022, which was requested by the companies that market these medicines.

13.06.2022 - PRAC recommendation

EMA recommends withdrawal of marketing authorisation for amfepramone medicines

EMA’s safety committee (PRAC) has recommended the withdrawal of EU marketing authorisations for amfepramone obesity medicines.

12.02.2021 - Procedure started

Review of amfepramone medicines started

EMA has started a review of obesity medicines that contain amfepramone. These medicines are authorised in some EU countries as treatment for patients with obesity (body mass index of at least 30 kg/m2) in whom other weight-reduction methods have not worked on their own. Amfepramone medicines are authorised to be used for 4 to 6 weeks and no longer than 3 months.

Further information

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