Efavirenz/Emtricitabine/Tenofovir disoproxil Krka

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efavirenz / 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 Efavirenz/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 the medicine.

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

This EPAR was last updated on 20/02/2018

Authorisation details

Product details
Name
Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
Agency product number
EMEA/H/C/004274
Active substance
  • efavirenz
  • emtricitabine
  • tenofovir disoproxil succinate
International non-proprietary name (INN) or common name
efavirenz / emtricitabine / tenofovir disoproxil
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AR06
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 and hybrid medicines.

Publication details
Marketing-authorisation holder
KRKA, d.d., Novo mesto
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
07/02/2018
Contact address
Smarjeska cesta 6
8501 Novo mesto
Slovenia

Product information

08/02/2018 Efavirenz/Emtricitabine/Tenofovir disoproxil Krka - EMEA/H/C/004274 - -

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

Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. It is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in Efavirenz/Emtricitabine/Tenofovir disoproxil Krka prior to initiation of their first antiretroviral treatment regimen.

The demonstration of the benefit of efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavirenz/emtricitabine/tenofovir disoproxil.

No data are currently available from clinical studies with efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in heavily pretreated patients.

No data are available to support the combination of efavirenz/emtricitabine/tenofovir disoproxil and other antiretroviral agents.

Assessment history

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