Provenge
autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor (sipuleucel-T)
Table of contents
Overview
The marketing authorisation for Provenge has been withdrawn at the request of the marketing authorisation holder.
Authorisation details
Product details | |
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Name |
Provenge
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Agency product number |
EMEA/H/C/002513
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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
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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)
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Therapeutic area (MeSH) |
Prostatic Neoplasms
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Anatomical therapeutic chemical (ATC) code |
L03AX17
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Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
Dendreon UK Ltd
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Revision |
1
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Date of issue of marketing authorisation valid throughout the European Union |
06/09/2013
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Contact address |
Product information
06/05/2015 Provenge - EMEA/H/C/002513 -
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
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Pharmacotherapeutic group
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.