Viracept
nelfinavir
Table of contents
Overview
The marketing authorisation for Viracept has not been renewed by the marketing-authorisation holder and is now withdrawn.
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
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
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.