EATG » Highlights from the CHMP November meeting

Highlights from the CHMP November meeting

At its November meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended for approval two generic versions of darunavir – Darunavir Krka and Darunavir Krka d.d. for the treatment of HIV infection.

Summary of opinion for Darunavir Krka is available here.
Summary of opinion for Darunavir Krka d.d. is available here.

CHMP also recommended an extension of therapeutic indications for Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) with marketing authorisation holder Gilead Sciences International Limited.

Summary of opinion for Genvoya is available here.

Source:
EMA
News categories: HIV treatment, EMA/FDA