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Triumeq (abacavir;dolutegravir;lamivudine)

Region

🇪🇺 EU

Active substance

abacavir;dolutegravir;lamivudine

Company

ViiV Healthcare B.V.

Status

Authorised

Therapeutic area

HIV Infections

CHMP opinion

Thu 26 Jun 2014

EU approval

Sun 31 Aug 2014

Application

EMEA/H/C/002754

ATC

J05AR13

Official record

www.ema.europa.eu

Indication

Triumeq is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infected children of at least 3 months of age weighing at least 6 kg to less than 25 kg (see sections 4.4 and 5.1). Before initiating treatment with abacavir-containing products, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin (see section 4.4). Abacavir should not be used in patients known to carry the HLA-B*5701 allele. Triumeq is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infected adults, adolescents and children weighing at least 25 kg (see sections 4.4 and 5.1). Before initiating treatment with abacavir-containing products, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin (see section 4.4). Abacavir should not be used in patients known to carry the HLA-B*5701 allele.

Regulatory milestones

No milestones recorded in the last year.

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.