efavirenz / emtricitabine / tenofovir disoproxil
Table of contents
The marketing authorisation for Atripla has been withdrawn at the request of the marketing-authorisation holder.
Atripla : EPAR - Medicine overview (PDF/675 KB)
First published: 21/10/2009
Last updated: 21/01/2022
Atripla : EPAR - Risk-management-plan summary (PDF/865.7 KB)
First published: 14/05/2019
Last updated: 21/01/2022
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Gilead Sciences Ireland UC
|Date of issue of marketing authorisation valid throughout the European Union||
IDA Business & Technology Park
17/08/2021 Atripla - EMEA/H/C/000797 - IB/0150
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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).
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Antivirals for systemic use
Atripla is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil fumarate. It is indicated for the treatment of human-immunodeficiency-virus-1 (HIV-1) infection in adults 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 Atripla prior to initiation of their first antiretroviral treatment regimen.
The demonstration of the benefit of Atripla 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 Atripla.
No data are currently available from clinical studies with Atripla in treatment-naive or in heavily pretreated patients.
No data are available to support the combination of Atripla and other antiretroviral agents.