Atripla

Withdrawn

This medicine's authorisation has been withdrawn

efavirenz / emtricitabine / tenofovir disoproxil

Overview

The marketing authorisation for Atripla has been withdrawn at the request of the marketing-authorisation holder.

Atripla : EPAR - Medicine overview

Atripla : EPAR - Risk-management-plan summary

Product information

Atripla : EPAR - Product Information

Latest procedure affecting product information: IB/0150

17/08/2021

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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).

Atripla : EPAR - All Authorised presentations

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 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.

Authorisation details

• EMA product number:
  EMEA/H/C/000797
• Marketing authorisation holder:
  Gilead Sciences Ireland UC

  IDA Business & Technology Park; Carrigtohill; County Cork; T45 DP77; Ireland

• Marketing authorisation issued:
  13/12/2007
• Revision:
  36

Assessment history

Changes since initial authorisation of medicine

Atripla : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Atripla : EPAR - Scientific Discussion

Atripla : EPAR - Procedural steps taken before authorisation