Emtricitabine/Tenofovir disoproxil Krka d.d.

RSS

emtricitabine / tenofovir disoproxil

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Emtricitabine/Tenofovir disoproxil Krka d.d. 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 d.d.

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

This EPAR was last updated on 06/08/2018

Authorisation details

Product details
Name
Emtricitabine/Tenofovir disoproxil Krka d.d.
Agency product number
EMEA/H/C/004686
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
J05AR03
Generic

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
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
28/04/2017
Contact address
Smarjeska cesta 6
8501 Novo mesto
Slovenia

Product information

25/07/2018 Emtricitabine/Tenofovir disoproxil Krka d.d. - EMEA/H/C/004686 - IAIN/0006

Contents

  • 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

ANTIVIRALS FOR SYSTEMIC USE

Therapeutic indication

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

Emtricitabine/Tenofovir disoproxil Krka d.d. 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.

Assessment history

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