Atripla

RSS

efavirenz / emtricitabine / tenofovir disoproxil

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Atripla has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 21/01/2022

Authorisation details

Product details
Name
Atripla
Agency product number
EMEA/H/C/000797
Active substance
  • efavirenz
  • emtricitabine
  • tenofovir disoproxil fumarate
International non-proprietary name (INN) or common name
  • efavirenz
  • emtricitabine
  • tenofovir disoproxil
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AR06
Publication details
Marketing-authorisation holder
Gilead Sciences Ireland UC
Revision
36
Date of issue of marketing authorisation valid throughout the European Union
13/12/2007
Contact address

IDA Business & Technology Park
Carrigtohill
County Cork
T45 DP77
Ireland

Product information

17/08/2021 Atripla - EMEA/H/C/000797 - IB/0150

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:

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

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.

Assessment history

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