Agenerase
Withdrawn
This medicine's authorisation has been withdrawn
amprenavir
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 20 October 2000 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Agenerase (amprenavir). Agenerase had been approved in combination with other antiretroviral agents for the treatment of protease inhibitor (PI) experienced HIV-1 infected adults and children above the age of 4 years.
The marketing authorisation holder (MAH) responsible for Agenerase was Glaxo Group Ltd. The European Commission was notified by letter dated 17 December 2009 of the MAH’s decision to voluntarily withdraw the marketing authorisation for Agenerase for commercial reasons. Agenerase had not been marketed anywhere in the European Union since the end of 2008.
On 29 April 2010 the European Commission issued a decision to withdraw the marketing authorisation for Agenerase. Pursuant to this decision the European Public Assessment Report for Agenerase is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:II/0044
29/04/2011
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
- Agenerase
- Active substance
- amprenavir
- International non-proprietary name (INN) or common name
- amprenavir
- Therapeutic area (MeSH)
- HIV Infections
- Anatomical therapeutic chemical (ATC) code
- J05AE05
Pharmacotherapeutic group
Antivirals for systemic useTherapeutic indication
Agenerase, in combination with other antiretroviral agents, is indicated for the treatment of protease inhibitor (PI) experienced HIV-1 infected adults and children above the age of 4 years. Agenerase capsules should normally be administered with low dose ritonavir as a pharmacokinetic enhancer of amprenavir (see sections 4.2 and 4.5). The choice of amprenavir should be based on individual viral resistance testing and treatment history of patients (see section 5.1).
The benefit of Agenerase boosted with ritonavir has not been demonstrated in PI nave patients (see section 5.1)
Assessment history
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