25.08.2014 - Notice within the graduated plan procedure ("Stufenplanverfahren")

By decision of 22 August 2014, the Federal Institute for Drugs and Medical Devices (BfArM) implements the corresponding implementing decision of the EU Commission of 23 June 2014 on zolpidem-containing medicinal products. The Implementing Decision contains amendments to the SPC and package leaflet.

28.04.2014 - Confirmation of the PRAC recommendation by the CMDh

The BfArM informs about the confirmation of the recommendation of the PRAC by the CMDh within the European risk assessment procedure according to article 31 of the directive 2001/83/EC.

07.03.2014 - PRAC recommendation

The BfArM provides information on the recommendation of the PRAC in the context of the European risk assessment procedure in accordance with Article 31 of Directive 2001/83/EC. The procedure was initiated by Italy, the rapporteur was the Netherlands and the co-rapporteur was Italy.

12.08.2013 - Procedure started

The BfArM issues information on the initiation of a European safety review according to Article 31 of Directive 2001/83/EC.

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)