Stocrin

Withdrawn

This medicine's authorisation has been withdrawn

efavirenz

Overview

On 30 September 2025, the European Commission withdrew the marketing authorisation for Stocrin (efavirenz) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Merck Sharp & Dohme B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Stocrin 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 additional 5-year periods in 2004 and 2009. It was then granted unlimited validity in 2014. The product had not been marketed in the EU since 2025.

Stocrin : EPAR - Summary for the public

Stocrin : EPAR - Risk management plan summary

Product information

Stocrin : EPAR - Product Information

Stocrin : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Stocrin
• 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

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

Stocrin 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 Stocrin.

Authorisation details

• EMA product number:
  EMEA/H/C/000250
• Marketing authorisation holder:
  Merck Sharp & Dohme B.V.

  Waarderweg 39; 2031 BN Haarlem; The Netherlands

• Opinion adopted:
  24/02/1999
• Marketing authorisation issued:
  28/05/1999
• Withdrawal of marketing authorisation:
  30/09/2025
• Revision:
  49

Assessment history

Changes since initial authorisation of medicine

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

Stocrin-H-C-250-P45-56: EPAR - Assessment Report

Adopted Reference Number: EMA/807379/2012

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

Initial marketing authorisation documents

Stocrin : EPAR - Scientific Discussion

Stocrin : EPAR - Procedural steps taken before authorisation