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The marketing authorisation for Agenerase has been withdrawn at the request of the marketing authorisation holder.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 28/11/2008 21/06/2011
Agenerase : EPAR - Summary for the public ES = español 28/11/2008 21/06/2011
Agenerase : EPAR - Summary for the public CS = čeština 28/11/2008 21/06/2011
Agenerase : EPAR - Summary for the public DA = dansk 28/11/2008 21/06/2011
Agenerase : EPAR - Summary for the public DE = Deutsch 28/11/2008 21/06/2011
Agenerase : EPAR - Summary for the public ET = eesti keel 28/11/2008 21/06/2011
Agenerase : EPAR - Summary for the public EL = elliniká 28/11/2008 21/06/2011
Agenerase : EPAR - Summary for the public EN = English 28/11/2008 21/06/2011
Agenerase : EPAR - Summary for the public FR = français 28/11/2008 21/06/2011
Agenerase : EPAR - Summary for the public IT = italiano 28/11/2008 21/06/2011
Agenerase : EPAR - Summary for the public LV = latviešu valoda 28/11/2008 21/06/2011
Agenerase : EPAR - Summary for the public LT = lietuvių kalba 28/11/2008 21/06/2011
Agenerase : EPAR - Summary for the public HU = magyar 28/11/2008 21/06/2011
Agenerase : EPAR - Summary for the public MT = Malti 28/11/2008 21/06/2011
Agenerase : EPAR - Summary for the public NL = Nederlands 28/11/2008 21/06/2011
Agenerase : EPAR - Summary for the public PL = polski 28/11/2008 21/06/2011
Agenerase : EPAR - Summary for the public PT = português 28/11/2008 21/06/2011
Agenerase : EPAR - Summary for the public RO = română 28/11/2008 21/06/2011
Agenerase : EPAR - Summary for the public SK = slovenčina 28/11/2008 21/06/2011
Agenerase : EPAR - Summary for the public SL = slovenščina 28/11/2008 21/06/2011
Agenerase : EPAR - Summary for the public FI = suomi 28/11/2008 21/06/2011
Agenerase : EPAR - Summary for the public SV = svenska 28/11/2008 21/06/2011

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

More detail is available in the summary of product characteristics

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 BG = bălgarski 16/12/2009 21/06/2011
Agenerase : EPAR - Product Information ES = español 16/12/2009 21/06/2011
Agenerase : EPAR - Product Information CS = čeština 16/12/2009 21/06/2011
Agenerase : EPAR - Product Information DA = dansk 16/12/2009 21/06/2011
Agenerase : EPAR - Product Information DE = Deutsch 16/12/2009 21/06/2011
Agenerase : EPAR - Product Information ET = eesti keel 16/12/2009 21/06/2011
Agenerase : EPAR - Product Information EL = elliniká 16/12/2009 21/06/2011
Agenerase : EPAR - Product Information EN = English 16/12/2009 21/06/2011
Agenerase : EPAR - Product Information FR = français 16/12/2009 21/06/2011
Agenerase : EPAR - Product Information IT = italiano 16/12/2009 21/06/2011
Agenerase : EPAR - Product Information LV = latviešu valoda 16/12/2009 21/06/2011
Agenerase : EPAR - Product Information LT = lietuvių kalba 16/12/2009 21/06/2011
Agenerase : EPAR - Product Information HU = magyar 16/12/2009 21/06/2011
Agenerase : EPAR - Product Information MT = Malti 16/12/2009 21/06/2011
Agenerase : EPAR - Product Information NL = Nederlands 16/12/2009 21/06/2011
Agenerase : EPAR - Product Information PL = polski 16/12/2009 21/06/2011
Agenerase : EPAR - Product Information PT = português 16/12/2009 21/06/2011
Agenerase : EPAR - Product Information RO = română 16/12/2009 21/06/2011
Agenerase : EPAR - Product Information SK = slovenčina 16/12/2009 21/06/2011
Agenerase : EPAR - Product Information SL = slovenščina 16/12/2009 21/06/2011
Agenerase : EPAR - Product Information FI = suomi 16/12/2009 21/06/2011
Agenerase : EPAR - Product Information SV = svenska 16/12/2009 21/06/2011

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 BG = bălgarski 21/10/2005 21/06/2011
Agenerase : EPAR - All Authorised presentations ES = español 21/10/2005 21/06/2011
Agenerase : EPAR - All Authorised presentations CS = čeština 21/10/2005 21/06/2011
Agenerase : EPAR - All Authorised presentations DA = dansk 21/10/2005 21/06/2011
Agenerase : EPAR - All Authorised presentations DE = Deutsch 21/10/2005 21/06/2011
Agenerase : EPAR - All Authorised presentations ET = eesti keel 21/10/2005 21/06/2011
Agenerase : EPAR - All Authorised presentations EL = elliniká 21/10/2005 21/06/2011
Agenerase : EPAR - All Authorised presentations EN = English 21/10/2005 21/06/2011
Agenerase : EPAR - All Authorised presentations FR = français 21/10/2005 21/06/2011
Agenerase : EPAR - All Authorised presentations IT = italiano 21/10/2005 21/06/2011
Agenerase : EPAR - All Authorised presentations LV = latviešu valoda 21/10/2005 21/06/2011
Agenerase : EPAR - All Authorised presentations LT = lietuvių kalba 21/10/2005 21/06/2011
Agenerase : EPAR - All Authorised presentations HU = magyar 21/10/2005 21/06/2011
Agenerase : EPAR - All Authorised presentations NL = Nederlands 21/10/2005 21/06/2011
Agenerase : EPAR - All Authorised presentations PL = polski 21/10/2005 21/06/2011
Agenerase : EPAR - All Authorised presentations PT = português 21/10/2005 21/06/2011
Agenerase : EPAR - All Authorised presentations RO = română 21/10/2005 21/06/2011
Agenerase : EPAR - All Authorised presentations SK = slovenčina 21/10/2005 21/06/2011
Agenerase : EPAR - All Authorised presentations SL = slovenščina 21/10/2005 21/06/2011
Agenerase : EPAR - All Authorised presentations FI = suomi 21/10/2005 21/06/2011
Agenerase : EPAR - All Authorised presentations SV = svenska 21/10/2005 21/06/2011

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 (English only) 16/12/2009 21/06/2011
Agenerase : EPAR - Steps taken after authorisation when a cutoff date has been used (English only) 21/10/2005 21/06/2011

Initial marketing-authorisation documents

Name Language First published Last updated
Agenerase : EPAR - Scientific Discussion (English only) 21/10/2005 21/06/2011
Agenerase : EPAR - Procedural steps taken before authorisation (English only) 21/10/2005 21/06/2011

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Agenerase