Viracept

Withdrawn

This medicine's authorisation has been withdrawn

nelfinavir

Overview

The marketing authorisation for Viracept has not been renewed by the marketing-authorisation holder and is now withdrawn.

Viracept : EPAR - Summary for the public

Product information

Viracept : EPAR - Product Information

Latest procedure affecting product information: N/0121

23/01/2013

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).

Viracept : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Viracept
• Active substance:
  nelfinavir
• International non-proprietary name (INN) or common name:
  nelfinavir
• Therapeutic area (MeSH):
  HIV Infections
• Anatomical therapeutic chemical (ATC) code:
  J05AE04

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000164
• Marketing authorisation holder:
  Roche Registration Ltd.

  Roche Registration Limited; 6 Falcon Way; Shire Park; Welwyn Garden City; AL7 1TW; United Kingdom

• Marketing authorisation issued:
  22/01/1998
• Revision:
  25

Assessment history

Changes since initial authorisation of medicine

Viracept : EPAR - Procedural steps taken and scientific information after authorisation

Viracept-H-C-164-II-119 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/764761/2011

Viracept-H-C-164-II-120: EPAR - Assessment Report - Variation

Adopted

Viracept-H-C-164-Z-109 : EPAR - Assessment Report - Lifting of suspension

Reference Number: EMEA/CHMP/492059/2007

Viracept-H-C-164-A20-107 : EPAR - Scientific Conclusion - Article 20

Viracept : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Viracept : EPAR - Scientific Discussion

Viracept : EPAR - Procedural steps taken before authorisation