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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
Common Name: autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor (sipuleucel-T)
ATC Code: L03AX17
Marketing Authorisation Holder: Dendreon UK Ltd
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
Status: Withdrawn
Authorisation Date: 2013-09-06
Therapeutic Area: Prostatic Neoplasms
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.

The marketing authorisation for Provenge has been withdrawn at the request of the marketing authorisation holder.

Source: European Medicines Agency

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