The European Medicines Agency (EMA) has confirmed its earlier recommendation to suspend a number of medicines for which authorisation in the European Union (EU) was primarily based on clinical studies conducted at Hyderabad-based GVK Biosciences.
This is the outcome of a re-examination requested by marketing authorisation holders for seven of the medicines concerned, according to a released issued by the agency on Friday.
As a result of this decision, around 700 pharmaceutical forms and strengths of medicines studied at the Hyderabad site remain recommended for suspension. For around 300 other pharmaceutical forms and strengths, sufficient supporting data from other sources had been provided; these medicines will therefore remain on the market in the EU.
The recommendation to suspend these medicines was first given by EMA’s Committee for Medicinal Products for Human Use (CHMP) in January 2015 following an inspection of GVK Biosciences’ site at Hyderabad by the French medicines agency (ANSM). Business Line
