Provenge

autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor (sipuleucel-T)

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The marketing authorisation for Provenge has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Provenge : EPAR - Summary for the public BG = bălgarski 2013-10-03 2015-05-19
Provenge : EPAR - Summary for the public ES = español 2013-10-03 2015-05-19
Provenge : EPAR - Summary for the public CS = čeština 2013-10-03 2015-05-19
Provenge : EPAR - Summary for the public DA = dansk 2013-10-03 2015-05-19
Provenge : EPAR - Summary for the public DE = Deutsch 2013-10-03 2015-05-19
Provenge : EPAR - Summary for the public ET = eesti keel 2013-10-03 2015-05-19
Provenge : EPAR - Summary for the public EL = elliniká 2013-10-03 2015-05-19
Provenge : EPAR - Summary for the public EN = English 2013-10-03 2015-05-19
Provenge : EPAR - Summary for the public FR = français 2013-10-03 2015-05-19
Provenge : EPAR - Summary for the public IT = italiano 2013-10-03 2015-05-19
Provenge : EPAR - Summary for the public LV = latviešu valoda 2013-10-03 2015-05-19
Provenge : EPAR - Summary for the public LT = lietuvių kalba 2013-10-03 2015-05-19
Provenge : EPAR - Summary for the public HU = magyar 2013-10-03 2015-05-19
Provenge : EPAR - Summary for the public MT = Malti 2013-10-03 2015-05-19
Provenge : EPAR - Summary for the public NL = Nederlands 2013-10-03 2015-05-19
Provenge : EPAR - Summary for the public PL = polski 2013-10-03 2015-05-19
Provenge : EPAR - Summary for the public PT = português 2013-10-03 2015-05-19
Provenge : EPAR - Summary for the public RO = română 2013-10-03 2015-05-19
Provenge : EPAR - Summary for the public SK = slovenčina 2013-10-03 2015-05-19
Provenge : EPAR - Summary for the public SL = slovenščina 2013-10-03 2015-05-19
Provenge : EPAR - Summary for the public FI = suomi 2013-10-03 2015-05-19
Provenge : EPAR - Summary for the public SV = svenska 2013-10-03 2015-05-19
Provenge : EPAR - Summary for the public HR = Hrvatski 2013-10-03 2015-05-19

This EPAR was last updated on 19/05/2015 .

More detail is available in the summary of product characteristics

Authorisation details

Product details

Product details for Provenge
NameProvenge
Agency product numberEMEA/H/C/002513
Active substance

autologous peripheral-blood mononuclear cells including a minimum of 50 million autologous CD54+ cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor

International non-proprietary name (INN) or common name

autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor (sipuleucel-T)

Therapeutic area Prostatic Neoplasms
Anatomical therapeutic chemical (ATC) code L03AX17
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Provenge
Marketing-authorisation holder

Dendreon UK Ltd

Revision1
Date of issue of marketing authorisation valid throughout the European Union06/09/2013

Contact address:

Dendreon UK Ltd
41 Chalton Street 
London NW1 1JD 
United Kingdom

Product information

Product information

06/05/2015  Provenge -EMEA/H/C/002513

Name Language First published Last updated
Provenge : EPAR - Product Information HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - Product Information HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - Product Information HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - Product Information HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - Product Information HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - Product Information HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - Product Information HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - Product Information HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - Product Information HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - Product Information HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - Product Information HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - Product Information HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - Product Information HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - Product Information HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - Product Information HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - Product Information HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - Product Information HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - Product Information HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - Product Information HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - Product Information HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - Product Information HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - Product Information HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - Product Information HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - Product Information HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - Product Information HR = Hrvatski 2013-10-03 2015-05-19

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
Provenge : EPAR - All Authorised presentations HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - All Authorised presentations HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - All Authorised presentations HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - All Authorised presentations HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - All Authorised presentations HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - All Authorised presentations HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - All Authorised presentations HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - All Authorised presentations HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - All Authorised presentations HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - All Authorised presentations HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - All Authorised presentations HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - All Authorised presentations HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - All Authorised presentations HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - All Authorised presentations HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - All Authorised presentations HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - All Authorised presentations HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - All Authorised presentations HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - All Authorised presentations HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - All Authorised presentations HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - All Authorised presentations HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - All Authorised presentations HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - All Authorised presentations HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - All Authorised presentations HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - All Authorised presentations HR = Hrvatski 2013-10-03 2015-05-19
Provenge : EPAR - All Authorised presentations HR = Hrvatski 2013-10-03 2015-05-19

Pharmacotherapeutic group

Other immunostimulants

Therapeutic indication

Provenge is indicated for treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate-resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Provenge : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2015-05-20  

Initial marketing-authorisation documents

Name Language First published Last updated
Provenge : EPAR - Public assessment report HR = Hrvatski 2013-10-03 2015-05-19
CHMP summary of positive opinion for Provenge HR = Hrvatski 2013-06-28 2015-05-19

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Provenge