Emtricitabine/Tenofovir disoproxil Krka


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 Krka. 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 Krka.

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

This EPAR was last updated on 17/08/2018

Authorisation details

Product details
Emtricitabine/Tenofovir disoproxil Krka
Agency product number
Active substance
  • emtricitabine
  • tenofovir disoproxil succinate
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 medicines.

Publication details
Marketing-authorisation holder
KRKA, d.d., Novo mesto
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Smarjeska cesta 6
8501 Novo mesto

Product information

25/07/2018 Emtricitabine/Tenofovir disoproxil Krka - EMEA/H/C/004215 - IAIN/0009


  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group


Therapeutic indication

Treatment of HIV-1 infection

Emtricitabine/tenofovir disoproxil Krka is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults.

Emtricitabine/Tenofovir disoproxil Krka is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years (see section 5.1

Pre-exposure prophylaxis (PrEP)

Emtricitabine/Tenofovir disoproxil Krka is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.

Assessment history

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