Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
efavirenz / emtricitabine / tenofovir disoproxil
Table of contents
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.
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Efavirenz/Emtricitabine/Tenofovir disoproxil Krka : EPAR - Summary for the public (PDF/95.85 KB)
First published: 20/02/2018
Last updated: 20/02/2018
EMA/9058/2018 -
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Efavirenz/Emtricitabine/Tenofovir disoproxil Krka : EPAR - Risk-management-plan summary (PDF/186.11 KB)
First published: 08/01/2019
Last updated: 17/03/2020
Authorisation details
Product details | |
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Name |
Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
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Agency product number |
EMEA/H/C/004274
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
HIV Infections
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Anatomical therapeutic chemical (ATC) code |
J05AR06
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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 | |
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Marketing-authorisation holder |
KRKA, d.d., Novo mesto
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Revision |
10
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Date of issue of marketing authorisation valid throughout the European Union |
08/02/2018
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Contact address |
Smarjeska cesta 6
8501 Novo mesto Slovenia |
Product information
15/06/2023 Efavirenz/Emtricitabine/Tenofovir disoproxil Krka - EMEA/H/C/004274 - IB/0016
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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.