Vitekta (elvitegravir)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- elvitegravir
- Company
- Gilead Sciences International Ltd
- Status
- Withdrawn
- Therapeutic area
- HIV Infections
- CHMP opinion
- Thu 19 Sep 2013
- EU approval
- Wed 13 Nov 2013
- Designations
- Additional monitoring
- Application
- EMEA/H/C/002577
- ATC
- J05AX11
- Official record
- www.ema.europa.eu
Indication
Vitekta co-administered with a ritonavir-boosted protease inhibitor and with other antiretroviral agents, is indicated for the treatment of human-immunodeficiency-virus-1 (HIV-1) infection in adults who are infected with HIV-1 without known mutations associated with resistance to elvitegravir.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Genvoya Authorised · Gilead Sciences Ireland UC
- 🇪🇺 Stribild Authorised · Gilead Sciences Ireland UC
Follow Vitekta
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.