Delstrigo (doravirine;lamivudine;tenofovir disoproxil)
- Region
- 🇪🇺 EU
- Active substance
- doravirine;lamivudine;tenofovir disoproxil
- Company
- Merck Sharp & Dohme B.V.
- Status
- Authorised
- Therapeutic area
- HIV Infections
- CHMP opinion
- Thu 20 Sep 2018
- EU approval
- Thu 22 Nov 2018
- Application
- EMEA/H/C/004746
- ATC
- J05AR
- Official record
- www.ema.europa.eu
Indication
Delstrigo is indicated for the treatment of adults infected with HIV 1 without past or present evidence of resistance to the NNRTI class, lamivudine, or tenofovir. Delstrigo is also indicated for the treatment of adolescents aged 12 years and older weighing at least 35 kg who are infected with HIV-1 without past or present evidence of resistance to the NNRTI class, lamivudine, or tenofovir and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil.
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.