Symtuza (darunavir;cobicistat;emtricitabine;tenofovir alafenamide)
- Region
- 🇪🇺 EU
- Active substance
- darunavir;cobicistat;emtricitabine;tenofovir alafenamide
- Company
- Janssen-Cilag International
- Status
- Authorised
- Therapeutic area
- HIV Infections
- CHMP opinion
- Wed 19 Jul 2017
- EU approval
- Thu 21 Sep 2017
- Application
- EMEA/H/C/004391
- ATC
- J05AR22
- Official record
- www.ema.europa.eu
Indication
Symtuza is indicated for the treatment of human immunodeficiency virus type 1 (HIV 1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg). Genotypic testing should guide the use of Symtuza.
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.