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):
To the risk assessment procedure (available in German only)