Viracept

RSS

nelfinavir

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Viracept has not been renewed by the marketing-authorisation holder and is now withdrawn.

This EPAR was last updated on 10/06/2014

Authorisation details

Product details
Name
Viracept
Agency product number
EMEA/H/C/000164
Active substance
nelfinavir
International non-proprietary name (INN) or common name
nelfinavir
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AE04
Publication details
Marketing-authorisation holder
Roche Registration Ltd.
Revision
25
Date of issue of marketing authorisation valid throughout the European Union
22/01/1998
Contact address
Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Product information

23/01/2013 Viracept - EMEA/H/C/000164 - N/0121

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

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

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.

Assessment history

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