Emtricitabine/Tenofovir disoproxil Zentiva

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 Zentiva. 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 Zentiva.

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

This EPAR was last updated on 23/01/2018

Authorisation details

Product details
Name
Emtricitabine/Tenofovir disoproxil Zentiva
Agency product number
EMEA/H/C/004137
Active substance
emtricitabine, tenofovir disoproxil phosphate
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
Zentiva k.s.
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
09/11/2016
Contact address
U kabelovny 130
Dolni Mecholupy
102 37 Prague 10
Czech Republic

Product information

13/10/2017 Emtricitabine/Tenofovir disoproxil Zentiva - EMEA/H/C/004137 - IB/0002/G

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 Zentiva is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults (see section 5.1).

Emtricitabine/Tenofovir disoproxil Zentiva 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).

Assessment history

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