In a notice dated 13 October 2016, the Federal Institute for Drugs and Medical Devices (BfArM) ruled the provisional suspension of a generic marketing authorisation that was based on a clinical trial conducted by the company Alkem Laboratories Ltd. in India. This is the realisation of the EU Commission's implementing decision of 8 September 2016.

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

Alkem