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\.
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.
Therapeutic Area (MeSH)
ATC Code
J05AG03
ATC Item
N/A
Pharmacotherapeutic Group
Antivirals for systemic use
Active Substance (Summary)
INN / Common Names
EMA Name
Stocrin
Medicine Name
Stocrin
Aliases
N/ANo risk management plan link.
