Dutrebis (lamivudine;raltegravir potassium)
- Region
- 🇪🇺 EU
- Active substance
- lamivudine;raltegravir potassium
- Company
- Merck Sharp Dohme Limited
- Status
- Withdrawn
- Therapeutic area
- HIV Infections
- EU approval
- Thu 26 Mar 2015
- Application
- EMEA/H/C/003823
- ATC
- J05AR16
- Official record
- www.ema.europa.eu
Indication
Dutrebis is indicated in combination with other anti?retroviral medicinal products for the treatment of human immunodeficiency virus (HIV?1) infection in adults, adolescents, and children from the age of 6 years and weighing at least 30 kg without present or past evidence of viral resistance to antiviral agents of the InSTI (Integrase Strand Transfer Inhibitor) and NRTI (Nucleoside Reverse Transcriptase Inhibitor) classes (see sections 4.2, 4.4 and 5.1).
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.