Juluca (dolutegravir;rilpivirine)
- Region
- 🇪🇺 EU
- Active substance
- dolutegravir;rilpivirine
- Company
- ViiV Healthcare B.V.
- Status
- Authorised
- Therapeutic area
- HIV Infections
- CHMP opinion
- Thu 22 Mar 2018
- EU approval
- Wed 16 May 2018
- Application
- EMEA/H/C/004427
- ATC
- J05AR
- Official record
- www.ema.europa.eu
Indication
Juluca is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor.
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.