Rezolsta (darunavir;cobicistat)
- Region
- 🇪🇺 EU
- Active substance
- darunavir;cobicistat
- Status
- Authorised
- Therapeutic area
- HIV Infections
- EU approval
- Wed 19 Nov 2014
- Application
- EMEA/H/C/002819
- ATC
- J05AR14
- Official record
- www.ema.europa.eu
Indication
Rezolsta is indicated, in combination with other antiretroviral medicinal products, for the treatment of human immunodeficiency virus 1 (HIV 1) infection in adults and paediatric patients (aged 6 years and older, weighing at least 25 kg). Genotypic testing should guide the use of Rezolsta.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Symtuza Authorised · Janssen-Cilag International
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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.