Agenerase
Withdrawn
This medicine's authorisation has been withdrawn
amprenavir
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Agenerase has been withdrawn at the request of the marketing authorisation holder.
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)
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