Emtricitabine/Tenofovir disoproxil Mylan (emtricitabine;tenofovir disoproxil)
- Region
- 🇪🇺 EU
- Active substance
- emtricitabine;tenofovir disoproxil
- Company
- Mylan Pharmaceuticals Limited
- Status
- Authorised
- Therapeutic area
- HIV Infections
- CHMP opinion
- Thu 13 Oct 2016
- EU approval
- Fri 16 Dec 2016
- Designations
- Generic
- Application
- EMEA/H/C/004050
- ATC
- J05AR03
- Official record
- www.ema.europa.eu
Indication
Treatment of HIV-1 infection: Emtricitabine/Tenofovir disoproxil Mylan is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults (see section 5.1). Emtricitabine/Tenofovir disoproxil Mylan is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, (see sections 4.2, 4.4 and 5.1). Pre-exposure prophylaxis (PrEP): Emtricitabine/Tenofovir disoproxil Mylan is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk (see sections 4.2, 4.4 and 5.1).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
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- 🇪🇺 Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan Authorised · Mylan Pharmaceuticals Limited
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- 🇪🇺 Emtricitabine/Tenofovir disoproxil Krka Authorised · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 Efavirenz/Emtricitabine/Tenofovir disoproxil Krka Authorised · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 Atripla Withdrawn · Gilead Sciences Ireland UC
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