Ziagen (abacavir)
- Region
- 🇪🇺 EU
- Active substance
- abacavir
- Company
- ViiV Healthcare B.V.
- Status
- Authorised
- Therapeutic area
- HIV Infections
- CHMP opinion
- Thu 25 Mar 1999
- EU approval
- Thu 08 Jul 1999
- Application
- EMEA/H/C/000252
- ATC
- J05AF06
- Official record
- www.ema.europa.eu
Indication
Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children. The demonstration of the benefit of Ziagen is mainly based on results of studies performed with a twice daily regimen, in treatment-naïve adult patients on combination therapy. Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Abacavir should not be used in patients known to carry the HLA-B*5701 allele.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Trizivir Withdrawn · ViiV Healthcare BV
- 🇪🇺 Triumeq Authorised · ViiV Healthcare B.V.
- 🇪🇺 Kivexa Authorised · ViiV Healthcare BV
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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.