Agenerase

amprenavir

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The marketing authorisation for Agenerase has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Agenerase : EPAR - Summary for the public BG = bălgarski 2008-11-28 2011-06-21
Agenerase : EPAR - Summary for the public ES = español 2008-11-28 2011-06-21
Agenerase : EPAR - Summary for the public CS = čeština 2008-11-28 2011-06-21
Agenerase : EPAR - Summary for the public DA = dansk 2008-11-28 2011-06-21
Agenerase : EPAR - Summary for the public DE = Deutsch 2008-11-28 2011-06-21
Agenerase : EPAR - Summary for the public ET = eesti keel 2008-11-28 2011-06-21
Agenerase : EPAR - Summary for the public EL = elliniká 2008-11-28 2011-06-21
Agenerase : EPAR - Summary for the public EN = English 2008-11-28 2011-06-21
Agenerase : EPAR - Summary for the public FR = français 2008-11-28 2011-06-21
Agenerase : EPAR - Summary for the public IT = italiano 2008-11-28 2011-06-21
Agenerase : EPAR - Summary for the public LV = latviešu valoda 2008-11-28 2011-06-21
Agenerase : EPAR - Summary for the public LT = lietuvių kalba 2008-11-28 2011-06-21
Agenerase : EPAR - Summary for the public HU = magyar 2008-11-28 2011-06-21
Agenerase : EPAR - Summary for the public MT = Malti 2008-11-28 2011-06-21
Agenerase : EPAR - Summary for the public NL = Nederlands 2008-11-28 2011-06-21
Agenerase : EPAR - Summary for the public PL = polski 2008-11-28 2011-06-21
Agenerase : EPAR - Summary for the public PT = português 2008-11-28 2011-06-21
Agenerase : EPAR - Summary for the public RO = română 2008-11-28 2011-06-21
Agenerase : EPAR - Summary for the public SK = slovenčina 2008-11-28 2011-06-21
Agenerase : EPAR - Summary for the public SL = slovenščina 2008-11-28 2011-06-21
Agenerase : EPAR - Summary for the public FI = suomi 2008-11-28 2011-06-21
Agenerase : EPAR - Summary for the public SV = svenska 2008-11-28 2011-06-21

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

Authorisation details

Product details

Product details for Agenerase
NameAgenerase
Agency product numberEMEA/H/C/000264
Active substance

amprenavir

International non-proprietary name (INN) or common name

amprenavir

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code J05AE05

Publication details

Publication details for Agenerase
Marketing-authorisation holder

Glaxo Group Ltd.

Revision18
Date of issue of marketing authorisation valid throughout the European Union20/10/2000

Contact address:

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

Product information

Product information

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

Name Language First published Last updated
Agenerase : EPAR - Product Information SV = svenska 2009-12-16 2011-06-21
Agenerase : EPAR - Product Information SV = svenska 2009-12-16 2011-06-21
Agenerase : EPAR - Product Information SV = svenska 2009-12-16 2011-06-21
Agenerase : EPAR - Product Information SV = svenska 2009-12-16 2011-06-21
Agenerase : EPAR - Product Information SV = svenska 2009-12-16 2011-06-21
Agenerase : EPAR - Product Information SV = svenska 2009-12-16 2011-06-21
Agenerase : EPAR - Product Information SV = svenska 2009-12-16 2011-06-21
Agenerase : EPAR - Product Information SV = svenska 2009-12-16 2011-06-21
Agenerase : EPAR - Product Information SV = svenska 2009-12-16 2011-06-21
Agenerase : EPAR - Product Information SV = svenska 2009-12-16 2011-06-21
Agenerase : EPAR - Product Information SV = svenska 2009-12-16 2011-06-21
Agenerase : EPAR - Product Information SV = svenska 2009-12-16 2011-06-21
Agenerase : EPAR - Product Information SV = svenska 2009-12-16 2011-06-21
Agenerase : EPAR - Product Information SV = svenska 2009-12-16 2011-06-21
Agenerase : EPAR - Product Information SV = svenska 2009-12-16 2011-06-21
Agenerase : EPAR - Product Information SV = svenska 2009-12-16 2011-06-21
Agenerase : EPAR - Product Information SV = svenska 2009-12-16 2011-06-21
Agenerase : EPAR - Product Information SV = svenska 2009-12-16 2011-06-21
Agenerase : EPAR - Product Information SV = svenska 2009-12-16 2011-06-21
Agenerase : EPAR - Product Information SV = svenska 2009-12-16 2011-06-21
Agenerase : EPAR - Product Information SV = svenska 2009-12-16 2011-06-21
Agenerase : EPAR - Product Information SV = svenska 2009-12-16 2011-06-21

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.


Name Language First published Last updated
Agenerase : EPAR - All Authorised presentations SV = svenska 2005-10-21 2011-06-21
Agenerase : EPAR - All Authorised presentations SV = svenska 2005-10-21 2011-06-21
Agenerase : EPAR - All Authorised presentations SV = svenska 2005-10-21 2011-06-21
Agenerase : EPAR - All Authorised presentations SV = svenska 2005-10-21 2011-06-21
Agenerase : EPAR - All Authorised presentations SV = svenska 2005-10-21 2011-06-21
Agenerase : EPAR - All Authorised presentations SV = svenska 2005-10-21 2011-06-21
Agenerase : EPAR - All Authorised presentations SV = svenska 2005-10-21 2011-06-21
Agenerase : EPAR - All Authorised presentations SV = svenska 2005-10-21 2011-06-21
Agenerase : EPAR - All Authorised presentations SV = svenska 2005-10-21 2011-06-21
Agenerase : EPAR - All Authorised presentations SV = svenska 2005-10-21 2011-06-21
Agenerase : EPAR - All Authorised presentations SV = svenska 2005-10-21 2011-06-21
Agenerase : EPAR - All Authorised presentations SV = svenska 2005-10-21 2011-06-21
Agenerase : EPAR - All Authorised presentations SV = svenska 2005-10-21 2011-06-21
Agenerase : EPAR - All Authorised presentations SV = svenska 2005-10-21 2011-06-21
Agenerase : EPAR - All Authorised presentations SV = svenska 2005-10-21 2011-06-21
Agenerase : EPAR - All Authorised presentations SV = svenska 2005-10-21 2011-06-21
Agenerase : EPAR - All Authorised presentations SV = svenska 2005-10-21 2011-06-21
Agenerase : EPAR - All Authorised presentations SV = svenska 2005-10-21 2011-06-21
Agenerase : EPAR - All Authorised presentations SV = svenska 2005-10-21 2011-06-21
Agenerase : EPAR - All Authorised presentations SV = svenska 2005-10-21 2011-06-21
Agenerase : EPAR - All Authorised presentations SV = svenska 2005-10-21 2011-06-21

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)

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Agenerase : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2009-12-16 2011-06-21
Agenerase : EPAR - Steps taken after authorisation when a cutoff date has been used SV = svenska 2005-10-21 2011-06-21

Initial marketing-authorisation documents

Name Language First published Last updated
Agenerase : EPAR - Procedural steps taken before authorisation SV = svenska 2005-10-21 2011-06-21
Agenerase : EPAR - Scientific Discussion SV = svenska 2005-10-21 2011-06-21

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Agenerase