Pifeltro (doravirine)
- Region
- 🇪🇺 EU
- Active substance
- doravirine
- 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/004747
- ATC
- J05AG06
- Official record
- www.ema.europa.eu
Indication
Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with HIV 1 without past or present evidence of resistance to the NNRTI class.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Delstrigo Authorised · Merck Sharp & Dohme B.V.
- 🇺🇸 Idvynso Approved · Msd
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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.