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Withdrawn
This medicine's authorisation has been withdrawn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
On 6 May 2015, the European Commission withdrew the marketing authorisation for Provenge (autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (sipuleucel-T)) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Dendreon UK Ltd, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Provenge was granted marketing authorisation in the EU on 6 September 2013 for treating men with asymptomatic or minimally symptomatic metastatic (non-visceral) castrate-resistant prostate cancer in whom chemotherapy is not yet clinically indicated. The marketing authorisation was initially valid for a 5- year period.
The European Public Assessment Report (EPAR) for Provenge is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
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).
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.
News on Provenge
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