Vemlidy (tenofovir alafenamide)
- Region
- 🇪🇺 EU
- Active substance
- tenofovir alafenamide
- Company
- Gilead Sciences Ireland UC
- Status
- Authorised
- Therapeutic area
- Hepatitis B
- CHMP opinion
- Thu 10 Nov 2016
- EU approval
- Mon 09 Jan 2017
- Application
- EMEA/H/C/004169
- ATC
- J05AF13
- Official record
- www.ema.europa.eu
Indication
Vemlidy is indicated for the treatment of chronic hepatitis B (CHB) in adults and paediatric patients 6 years of age and older weighing at least 25 kg (see section 5.1).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Symtuza Authorised · Janssen-Cilag International
- 🇪🇺 Genvoya Authorised · Gilead Sciences Ireland UC
- 🇪🇺 Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatris Authorised · Viatris Limited
- 🇪🇺 Emtricitabine / Tenofovir alafenamide Viatris Authorised · Viatris Limited
- 🇪🇺 Biktarvy Authorised · Gilead Sciences Ireland UC
- 🇪🇺 Descovy Authorised · Gilead Sciences Ireland UC
- 🇪🇺 Odefsey Authorised · Gilead Sciences Ireland UC
Follow Vemlidy
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.