Biktarvy (bictegravir;emtricitabine;tenofovir alafenamide)
- Region
- 🇪🇺 EU
- Active substance
- bictegravir;emtricitabine;tenofovir alafenamide
- Company
- Gilead Sciences Ireland UC
- Status
- Authorised
- Therapeutic area
- HIV Infections
- CHMP opinion
- Thu 26 Apr 2018
- EU approval
- Thu 21 Jun 2018
- Application
- EMEA/H/C/004449
- ATC
- J05AR20
- Official record
- www.ema.europa.eu
Indication
Biktarvy is indicated for the treatment of human immunodeficiency virus 1 (HIV 1) infection in adults and paediatric patients at least 2 years of age and weighing at least 14 kg i without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.(see section 5.1)
Regulatory milestones
No milestones recorded in the last year.
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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.