The European Medicines Agency has been formally notified by Sanofi-aventis of its decision to withdraw its application for a centralised marketing authorisation for the medicine Mulsevo (semuloparin sodium), 20 mg, solution for injection. Mulsevo was intended to be used for the primary prophylaxis of venous thromboembolism (VTE) in cancer patients receiving chemotherapy for locally-advanced or metastatic solid tumours.

 

The application for the marketing authorisation for Mulsevo was submitted to the Agency on 29 September 2011. At the time of the withdrawal it was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP).

 

In its withdrawal letter, the company stated that it decided to withdraw all applications globally following comments by regulatory agencies.

 

Posted on the EMA website on 9 July 2012