Table of contents
The marketing authorisation for Viracept has not been renewed by the marketing-authorisation holder and is now withdrawn.
Viracept : EPAR - Summary for the public (PDF/527.82 KB)
First published: 27/08/2008
Last updated: 10/06/2014
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Roche Registration Ltd.
|Date of issue of marketing authorisation valid throughout the European Union||
Roche Registration Limited
6 Falcon Way
Welwyn Garden City
23/01/2013 Viracept - EMEA/H/C/000164 - N/0121
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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).
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Antivirals for systemic use
Viracept is indicated in antiretroviral combination treatment of human-immunodeficiency-virus (HIV-1)-infected adults, adolescents and children of three years of age and older.
In protease-inhibitor (PI)-experienced patients, the choice of nelfinavir should be based on individual viral resistance testing and treatment history.
European Medicines Agency finalises review of medicines concerned by Roche pharmacovigilance inspection19/11/2013
European Medicines Agency starts infringement procedure to investigate Roche's alleged non-compliance with pharmacovigilance obligations23/10/2012
Studies assessed by the European Medicines Agency indicate no increased risk of developing cancer for patients who have taken Viracept contaminated with ethyl mesilate24/07/2008
European Medicines Agency agrees on action plan following the recall of Viracept and recommends suspension of the marketing authorisation21/09/2007