Updated on 10 July 2012
Singapore: Sanofi-aventis has notified European Medicines Agency 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 they have decided to withdraw all applications globally following comments by regulatory agencies.