Atripla
Withdrawn
This medicine's authorisation has been withdrawn
efavirenz / emtricitabine / tenofovir disoproxil
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 15 November 2021, the European Commission withdrew the marketing authorisation for Atripla (efavirenz / emtricitabine / tenofovir disoproxil) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Gilead Sciences Ireland UC, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Atripla was granted marketing authorisation in the EU on 13 December 2007 for treatment of HIV-1 infection. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2012.
The European Public Assessment Report (EPAR) for Atripla is updated to indicate that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
IB/0150
17/08/2021
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).
Product details
- Name of medicine
- Atripla
- 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
Pharmacotherapeutic group
Antivirals for systemic useTherapeutic 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.
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