BfArM - Federal Institute for Drugs and Medical Devices

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Methadone-containing drugs, with povidone (as pharmaceutical excipient): severe side effects due to misuse

2014.07.25

Active substance: Methadone

25.07.2014 - CMDh position

The BfArM issues information on the unanimous consensus of the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) to suspend the marketing authorisation of oral methadone solutions containing high molecular weight povidone.

14.07.2014 - PRAC recommendation

The BfArM issues information on the PRAC recommendation within a European safety review according to Article 107i of Directive 2001/83/EC--European Community.

11.04.2014 - Procedure started

The BfArM issues information on the initiation of a European safety review according to Article 107i of Directive 2001/83/EC--European Community.

Further information

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

Methadone medicinal products for oral use containing povidone

To the risk assessment procedure (available in German only)