Provenge
Withdrawn
This medicine's authorisation has been withdrawn
autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor (sipuleucel-T)
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Provenge has been withdrawn at the request of the marketing authorisation holder.
Provenge : EPAR - Summary for the public
Reference Number: EMA/410890/2013
English (EN) (545.79 KB - PDF)
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български (BG) (628.86 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
español (ES) (544.66 KB - PDF)
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čeština (CS) (610.2 KB - PDF)
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dansk (DA) (545 KB - PDF)
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Deutsch (DE) (573.84 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
eesti keel (ET) (543.14 KB - PDF)
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ελληνικά (EL) (631.55 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
français (FR) (551 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
hrvatski (HR) (566.49 KB - PDF)
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italiano (IT) (543.38 KB - PDF)
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latviešu valoda (LV) (626.34 KB - PDF)
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lietuvių kalba (LT) (570.71 KB - PDF)
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magyar (HU) (602.68 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
Malti (MT) (613.34 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
Nederlands (NL) (543.66 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
polski (PL) (609.79 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
português (PT) (544.41 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
română (RO) (571.49 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
slovenčina (SK) (610.13 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
slovenščina (SL) (1.1 MB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
Suomi (FI) (541.78 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
svenska (SV) (544.4 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
Product information
Provenge : EPAR - Product Information
English (EN) (874.11 KB - PDF)
First published: Last updated:
български (BG) (1.7 MB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
español (ES) (897.93 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
čeština (CS) (1.41 MB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
dansk (DA) (883.3 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
Deutsch (DE) (925.15 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
eesti keel (ET) (874.85 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
ελληνικά (EL) (1.72 MB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
français (FR) (917.88 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
hrvatski (HR) (1.03 MB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
íslenska (IS) (944.48 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
italiano (IT) (858.5 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
latviešu valoda (LV) (1.45 MB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
lietuvių kalba (LT) (990.83 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
magyar (HU) (1.44 MB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
Malti (MT) (1.46 MB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
Nederlands (NL) (856.93 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
norsk (NO) (876.08 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
polski (PL) (1.45 MB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
português (PT) (945.01 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
română (RO) (1.01 MB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
slovenčina (SK) (1.41 MB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
slovenščina (SL) (1.45 MB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
Suomi (FI) (934.22 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
svenska (SV) (887.25 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
06/05/2015
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Provenge : EPAR - All Authorised presentations
English (EN) (483.34 KB - PDF)
First published: Last updated:
български (BG) (532.33 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
español (ES) (484.74 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
čeština (CS) (519.47 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
dansk (DA) (482.74 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
Deutsch (DE) (482.78 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
eesti keel (ET) (484.49 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
ελληνικά (EL) (529.06 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
français (FR) (482.6 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
hrvatski (HR) (504.53 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
íslenska (IS) (484.36 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
italiano (IT) (482.69 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
latviešu valoda (LV) (523.51 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
lietuvių kalba (LT) (511.81 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
magyar (HU) (510.86 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
Malti (MT) (529.82 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
Nederlands (NL) (482.49 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
norsk (NO) (484.5 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
polski (PL) (522.96 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
português (PT) (482.87 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
română (RO) (514.45 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
slovenčina (SK) (514.08 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
slovenščina (SL) (986.07 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
Suomi (FI) (482.33 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
svenska (SV) (482.7 KB - PDF)
First published: 03/10/2013Last updated: 19/05/2015
Product details
- Name of medicine
- Provenge
- 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
Pharmacotherapeutic group
Other immunostimulantsTherapeutic 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.
Authorisation details
- EMA product number
- EMEA/H/C/002513
Advanced therapy
This medicine is classified as an advanced therapy medicinal product (ATMP): a medicine for human use that is based on genes, tissues or cells. It offers groundbreaking new opportunities for the treatment of disease and injury. For more information, see Advanced therapy medicinal products: Overview.
- Marketing authorisation holder
- Dendreon UK Ltd
41 Chalton Street
London NW1 1JD
United Kingdom - Marketing authorisation issued
- 06/09/2013
- Revision
- 1
Assessment history
Provenge : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (532.51 KB - PDF)
First published: Last updated:
Provenge : EPAR - Public assessment report
AdoptedReference Number: EMA/440011/2013
English (EN) (4.12 MB - PDF)
First published: Last updated:
CHMP summary of positive opinion for Provenge
AdoptedReference Number: EMA/CHMP/363851/2013
English (EN) (531.29 KB - PDF)
First published: Last updated:
News on Provenge
More information on Provenge
Public statement on Provenge: Withdrawal of the marketing authorisation in the European Union
Reference Number: EMA/303072/2015
English (EN) (65.31 KB - PDF)
First published: Last updated:
More information on Provenge
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