The marketing authorisation for Agenerase has been withdrawn at the request of the marketing authorisation holder.
Agenerase : EPAR - Summary for the public (PDF/263.12 KB)
First published: 28/11/2008
Last updated: 21/06/2011
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Glaxo Group Ltd.
|Date of issue of marketing authorisation valid throughout the European Union||
29/04/2011 Agenerase - EMEA/H/C/000264 - II/0044
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Antivirals for systemic use
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)