Sustiva

Withdrawn

This medicine's authorisation has been withdrawn

efavirenz

Overview

The marketing authorisation for Sustiva has been withdrawn at the request of the marketing-authorisation holder.

Sustiva : EPAR - Summary for the public

Product information

Sustiva : EPAR - Product Information

Latest procedure affecting product information: N/0161

23/05/2023

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).

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

• Marketing authorisation issued:
  28/05/1999
• 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