Viracept
Withdrawn
This medicine's authorisation has been withdrawn
nelfinavir
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
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European Public Assessment Report for Viracept is updated accordingly to reflect that the marketing authorisation is no longer valid.
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).
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 useTherapeutic 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.
News on Viracept
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