Stocrin

RSS

efavirenz

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 12/08/2019

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
41
Date of issue of marketing authorisation valid throughout the European Union
28/05/1999
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

07/06/2019 Stocrin - EMEA/H/C/000250 - N/0120

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

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