Sustiva

Withdrawn

This medicine's authorisation has been withdrawn

efavirenz

Overview

On 1 February 2024, the European Commission withdrew the marketing authorisation for Sustiva (efavirenz) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Bristol-Myers Squibb Pharma EEIG, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Sustiva was granted marketing authorisation in the EU on 28 May 1999 for treatment of HIV-1 infection. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2004, and in 2009. It was then granted unlimited validity in 2014. 

There are generic medicinal products of efavirenz authorised and marketed in the EU. 

The European Public Assessment Report (EPAR) for Sustiva is updated to indicate that the marketing authorisation is no longer valid.

Sustiva : EPAR - Summary for the public

Product information

Sustiva : EPAR - Product Information

Sustiva : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Sustiva
• Active substance:
  efavirenz
• International non-proprietary name (INN) or common name:
  efavirenz
• Therapeutic area (MeSH):
  HIV Infections
• Anatomical therapeutic chemical (ATC) code:
  J05AG03

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Sustiva is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older.

Sustiva has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm³, or after failure of protease-inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing Sustiva.

Authorisation details

• EMA product number:
  EMEA/H/C/000249
• Marketing authorisation holder:
  Bristol-Myers Squibb Pharma EEIG

  Plaza 254; Blanchardstown Corporate Park 2; Dublin 15; D15 T867; Ireland

• Opinion adopted:
  24/02/1999
• Marketing authorisation issued:
  28/05/1999
• Withdrawal of marketing authorisation:
  01/02/2024
• Revision:
  48

Assessment history

Changes since initial authorisation of medicine

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

Sustiva-H-C-PSUSA-00001200-201804 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/132484/2019

Sustiva-H-C-249-II-0126-G : EPAR - Scientific Discussion - Variation

AdoptedReference Number: EMA/260283/2015

CHMP post-authorisation summary of positive opinion for Sustiva

AdoptedReference Number: EMA/CHMP/104007/2015

Sustiva-H-C-249-P45-0056: EPAR - Assessment Report

AdoptedReference Number: EMA/815692/2012

Sustiva : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Sustiva : EPAR - Scientific Discussion

Sustiva : EPAR - Procedural steps taken before authorisation