Meeting highlights from Europe's CHMP November 16-19, 2009

Following its November 16-19 meetings, the European Medicines Agency (EMEA) says it has reviewed further data on the centrally authorized pandemic vaccines, Celvapan (from Baxter International), Focetria (from Novartis) and Pandemrix (from GlaxoSmithKline). The Agency has reaffirmed that they have a positive balance of benefits and risks in the context of the current H1N1 infuenza pandemic.

Positive opinions for new medicines adopted

The Committee adopted positive opinions, recommending the granting of a marketing authorization, for the following new medicines

* Elonva (corifollitropin alfa), from NV Organon, intended for controlled ovarian stimulation for the development of multiple follicles in women participating in an Assisted Reproductive Technology program. The review of Elonva began on December 24, 2008, with an active review time of 205 days; and
* Urorec and Silodyx (silodosin), from Recordati Ireland, intended for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). The review for Urorec began on November 19, 2008, with an active review time of 205 days. The review for Silodyx began on July 26, 2009, with an active review time of 85 days and was aligned with that of Urorec.

Negative opinion for two medicines adopted

The Committee also adopted two negative opinions, recommending that the following medicines should not be granted a marketing authorization: