Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

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On 22 June 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, intended for the treatment of HIV infection. The applicant for this medicinal product is Mylan S.A.S.

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan contains as active substances the antiretrovirals efavirenz, emtricitabine and tenofovir disoproxil (ATC code: J05AR06). The medicine will be available as film-coated tablets (600 mg/200 mg/245 mg). Efavirenz is a non-competitive inhibitor of HIV reverse transcriptase while emtricitabine and tenofovir disoproxil are substrates and competitive inhibitors of HIV reverse transcriptase. After phosphorylation, they are incorporated into the viral DNA chain, resulting in chain termination.

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is a generic of Atripla which has been authorised in the EU since 13 December 2007. Studies have demonstrated the satisfactory quality of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, and its bioequivalence to the reference product Atripla.

The full indication is:

"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".

It is proposed that Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan be prescribed by physicians experienced in the management of HIV infection.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Name Language First published Last updated
CHMP summary of positive opinion for Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan (English only) 2017-06-23  

Key facts

Product details for Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
NameEfavirenz/Emtricitabine/Tenofovir disoproxil Mylan
INN or common name

efavirenz / emtricitabine / tenofovir disoproxil

Therapeutic area HIV Infections
Active substance

efavirenz / emtricitabine / tenofovir disoproxil maleate

Date opinion adopted22/06/2017
Company name

Mylan S.A.S.

StatusPositive
Application typeInitial authorisation

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