Isentress (raltegravir)
Accelerated assessment
- Region
- 🇪🇺 EU
- Active substance
- raltegravir
- Company
- Merck Sharp & Dohme B.V.
- Status
- Authorised
- Therapeutic area
- HIV Infections
- CHMP opinion
- Thu 15 Nov 2007
- EU approval
- Wed 19 Dec 2007
- Designations
- Accelerated assessment
- Application
- EMEA/H/C/000860
- ATC
- J05AJ01
- Official record
- www.ema.europa.eu
Indication
Isentress is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Raltegravir Viatris Application withdrawn · Viatris Limited
- 🇪🇺 Dutrebis Withdrawn · Merck Sharp Dohme Limited
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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.