sexta-feira, dezembro 15, 2006
TMC114 vem aí
CORK, Ireland--(BUSINESS WIRE)--Tibotec Pharmaceuticals, Ltd. announced today that the Committee for Human Medicinal Products (CHMP) in the European Union has granted a positive opinion recommending conditional approval of PREZISTA(tm) (darunavir, also known by the investigational compound number TMC114), an anti-HIV medication.
The CHMP is the committee responsible for the scientific assessment of products seeking one centralised marketing authorisation applicable throughout the European Union. Tibotec anticipates receiving the conditional marketing authorisation from the European Commission by early next year.
The proposed indication is: "PREZISTA, co-administered with 100 mg ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in highly pre-treated adult patients who failed more than one regimen containing a protease inhibitor (PI)." Darunavir is currently approved in the United States, Canada, Russia and Switzerland and is pending approval in other markets.
For further information, please visit www.tibotec.com.