Viracept

Withdrawn

This medicine's authorisation has been withdrawn

nelfinavir

Overview

On 22 January 1998 the European Commission granted a marketing authorisation for the whole European Union to Roche Registration Limited for Viracept (nelfinavir), an antiretroviral agent of the protease inhibitor class. Viracept was indicated for use in antiretroviral combination treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children of 3 years of age and older. The marketing authorisation was valid for a 5-year period. It subsequently was renewed for additional 5-year periods in 2003 and 2008. Before the expiry of the last 5-year period of validity the Marketing Authorisation Holder did not apply to renew the marketing authorisation. 

Consequently, the marketing authorisation for Viracept expired on 23 January 2013. The European Public Assessment Report for Viracept is updated accordingly to reflect that the marketing authorisation is no longer valid.

Viracept : EPAR - Summary for the public

Product information

Viracept : EPAR - Product Information

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.

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

• Marketing authorisation issued:
  22/01/1998
• Withdrawal of marketing authorisation:
  23/01/2013
• 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

Adopted Reference 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