Marketing authorisations based on studies conducted by the company Micro Therapeutic Research Labs in India: Suspension of marketing authorisation
Active substance several
In a notice dated 13 July 2017, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the provisional suspension of generic marketing authorisations based on clinical trials conducted by the company Micro Therapeutic Research Labs in India. This is the realisation of the EU Commission's implementing decision of 23 June 2017.
To the risk assessment procedure (available in German only)
For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):
Micro Therapeutic Research