Meeting highlights from the Committee for Medicinal Products for Human Use, 16 to 19 Mar 2009: Initial evaluation - positive opinions.

At its meeting of 16 to 19 Mar 2009, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions, recommending the granting of a marketing authorisation, for the following medicines: Ellaone (ulipristal acetate), from Laboratoire HRA Pharma, indicated for emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure. EMEA review began on 25 Jun 2008, with an active review time of 203 days. Modigraf (tacrolimus), from Astellas Pharma Europe BV, indicated for the prophylaxis and treatment of transplant rejection in adult and paediatric kidney, liver or heart allograft …