Agenerase

amprenavir

The marketing authorisation for Agenerase has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 21/06/2011 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

29/04/2011  Agenerase -EMEA/H/C/000264 -II/0044

Contents

• 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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Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic 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 naïve patients (see section 5.1)

Changes since initial authorisation of medicine

Initial marketing-authorisation documents