Provenge

RSS

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

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Provenge has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 19/05/2015

Authorisation details

Product details
Name
Provenge
Agency product number
EMEA/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 (MeSH)
Prostatic Neoplasms
Anatomical therapeutic chemical (ATC) code
L03AX17
Additional monitoringAdditional 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
Marketing-authorisation holder
Dendreon UK Ltd
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
06/09/2013
Contact address
41 Chalton Street
London NW1 1JD
United Kingdom

Product information

06/05/2015 Provenge - EMEA/H/C/002513 -

Contents

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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

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