Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan (efavirenz;emtricitabine;tenofovir disoproxil)
- Region
- 🇪🇺 EU
- Active substance
- efavirenz;emtricitabine;tenofovir disoproxil
- Company
- Mylan Pharmaceuticals Limited
- Status
- Authorised
- Therapeutic area
- HIV Infections
- CHMP opinion
- Thu 22 Jun 2017
- EU approval
- Tue 05 Sep 2017
- Designations
- Generic
- Application
- EMEA/H/C/004240
- ATC
- J05AR06
- Official record
- www.ema.europa.eu
Indication
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. It is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan prior to initiation of their first antiretroviral treatment regimen. The demonstration of the benefit of efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavirenz/emtricitabine/tenofovir disoproxil (see section 5.1). No data are currently available from clinical studies with efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in heavily pretreated patients. No data are available to support the combination of efavirenz/emtricitabine/tenofovir disoproxil and other antiretroviral agents.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva Authorised · Zentiva k.s.
- 🇪🇺 Efavirenz/Emtricitabine/Tenofovir disoproxil Krka Authorised · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 Atripla Withdrawn · Gilead Sciences Ireland UC
Follow Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.