Apretude (cabotegravir)
- Region
- 🇪🇺 EU
- Active substance
- cabotegravir
- Company
- ViiV Healthcare B.V.
- Status
- Authorised
- Therapeutic area
- HIV Infections
- CHMP opinion
- Thu 20 Jul 2023
- EU approval
- Fri 15 Sep 2023
- Application
- EMEA/H/C/005756
- ATC
- J05AJ04
- Official record
- www.ema.europa.eu
Indication
Apretude is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents, weighing at least 35 kg (see sections 4.2, 4.4 and 5.1).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Vocabria Authorised · ViiV Healthcare B.V.
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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.