Agenerase

RSS

amprenavir

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Agenerase has been withdrawn at the request of the marketing authorisation holder.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

Authorisation details

Product details
Name
Agenerase
Agency product number
EMEA/H/C/000264
Active substance
amprenavir
International non-proprietary name (INN) or common name
amprenavir
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AE05
Publication details
Marketing-authorisation holder
Glaxo Group Ltd.
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
20/10/2000
Contact address
Glaxo Group Limited
Greenford Road
Greenford, Middx UB6 0NN
United Kingdom

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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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 nave patients (see section 5.1)

Assessment history

How useful was this page?

Add your rating