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Emtricitabine / Tenofovir alafenamide Viatris (emtricitabine;tenofovir alafenamide)

Generic
Region
🇪🇺 EU
Active substance
emtricitabine;tenofovir alafenamide
Company
Viatris Limited
Status
Authorised
Therapeutic area
HIV Infections
CHMP opinion
Thu 22 May 2025
EU approval
Fri 18 Jul 2025
Designations
Generic
Application
EMEA/H/C/006469
ATC
J05AR17
Official record
www.ema.europa.eu

Indication

Emtricitabine/Tenofovir alafenamide Viatris is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus type 1 (HIV-1).

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

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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.