Emtricitabine/Tenofovir disoproxil Mylan


emtricitabine / tenofovir disoproxil

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Emtricitabine/Tenofovir disoproxil Mylan. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Emtricitabine/Tenofovir disoproxil Mylan.

For practical information about using Emtricitabine/Tenofovir disoproxil Mylan, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 27/03/2019

Authorisation details

Product details
Emtricitabine/Tenofovir disoproxil Mylan
Agency product number
Active substance
  • emtricitabine
  • tenofovir disoproxil maleate
International non-proprietary name (INN) or common name
emtricitabine / tenofovir disoproxil
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Mylan S.A.S
Date of issue of marketing authorisation valid throughout the European Union
Contact address

117 Allee des Parcs

Product information

22/02/2019 Emtricitabine/Tenofovir disoproxil Mylan - EMEA/H/C/004050 - N/0007


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Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Emtricitabine/Tenofovir disoproxil Mylan is indicated in antiretroviral combination therapy for the treatment of HIV 1 infected adults.

Assessment history

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