19.07.2021 - Revocation of approval

Marketing authorizations for tetrazepam-containing drugs are being revoked because the risk-benefit ratio is unfavorable.

16.07.2019 - Ordering the suspension of authorizations in the framework of the implementation of the Commission decision

On 29 May 2013, the European Commission decided to suspend the marketing authorisations of medicinal products containing tetrazepam. In view of the suspension of the marketing authorisations of tetrazepam-containing medicines, the BfArM has ruled an extension of the suspension. In a notice dated 28 July 2017, the BfArM has ruled that the suspension will be extended for the time being until 31 July 2019.

In a notice dated 12.07.2019 the BfArM has again ruled an extension of the sespension of the marketing authorisations until 31.07.2021.

Further information

To the risk assessment procedure (available in German only)