Stocrin
efavirenz
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Stocrin. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Stocrin.
For practical information about using Stocrin, patients should read the package leaflet or contact their doctor or pharmacist.
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List item
Stocrin : EPAR - Summary for the public (PDF/83.19 KB)
First published: 30/04/2009
Last updated: 25/01/2018 -
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Stocrin : EPAR - Risk management plan summary (PDF/142.32 KB)
First published: 25/04/2023
Authorisation details
Product details | |
---|---|
Name |
Stocrin
|
Agency product number |
EMEA/H/C/000250
|
Active substance |
efavirenz
|
International non-proprietary name (INN) or common name |
efavirenz
|
Therapeutic area (MeSH) |
HIV Infections
|
Anatomical therapeutic chemical (ATC) code |
J05AG03
|
Publication details | |
---|---|
Marketing-authorisation holder |
Merck Sharp & Dohme B.V.
|
Revision |
49
|
Date of issue of marketing authorisation valid throughout the European Union |
28/05/1999
|
Contact address |
Waarderweg 39 |
Product information
14/04/2023 Stocrin - EMEA/H/C/000250 - II/130
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.