Viracept
nelfinavir
Table of contents
Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Viracept has not been renewed by the marketing-authorisation holder and is now withdrawn.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
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Pharmacotherapeutic group
Pharmacotherapeutic group
Antivirals for systemic use
Therapeutic indication
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.