Agenerase

Withdrawn

This medicine's authorisation has been withdrawn

amprenavir

Overview

The marketing authorisation for Agenerase has been withdrawn at the request of the marketing authorisation holder.

Agenerase : EPAR - Summary for the public

Product information

Agenerase : EPAR - Product Information

Latest procedure affecting product information: II/0044

29/04/2011

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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).

Agenerase : EPAR - All Authorised presentations

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 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)

Authorisation details

• EMA product number:
  EMEA/H/C/000264
• Marketing authorisation holder:
  Glaxo Group Ltd.

  Glaxo Group Limited; Greenford Road; Greenford, Middx UB6 0NN; United Kingdom

• Marketing authorisation issued:
  20/10/2000
• Revision:
  18

Assessment history

Changes since initial authorisation of medicine

Agenerase : EPAR - Procedural steps taken and scientific information after authorisation

Agenerase : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Agenerase : EPAR - Procedural steps taken before authorisation

Agenerase : EPAR - Scientific Discussion