Emtricitabine/Tenofovir disoproxil Mylan


emtricitabine / tenofovir disoproxil

This medicine is authorised for use in the European Union.


Emtricitabine/Tenofovir disoproxil Mylan is an HIV medicine that is used in combination with at least one other HIV medicine to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). In addition, it may be used in adolescents with HIV who are resistant to first-line treatments or who cannot take them because of side effects.

Emtricitabine/Tenofovir disoproxil Mylan is also used to help prevent sexually transmitted HIV-1 infection in adults and adolescents who are at high risk of being infected (pre-exposure prophylaxis or PrEP). It should be used in combination with safer sex practices, such as use of condoms.

Emtricitabine/Tenofovir disoproxil Mylan contains two active substances, emtricitabine and tenofovir disoproxil. It is a ‘generic medicine’. This means that it contains the same active substances and works in the same way as a ‘reference medicine’ already authorised in the EU called Truvada.

This EPAR was last updated on 27/07/2023

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 Pharmaceuticals Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Mylan Pharmaceuticals Limited
Damastown Industrial Park
Dublin 15

Product information

05/07/2023 Emtricitabine/Tenofovir disoproxil Mylan - EMEA/H/C/004050 - IB/0024/G

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic 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).

Assessment history

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