Provenge (autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor (sipuleucel-T))
ATMPAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor (sipuleucel-T)
- Company
- Dendreon UK Ltd
- Status
- Withdrawn
- Therapeutic area
- Prostatic Neoplasms
- EU approval
- Fri 06 Sep 2013
- Designations
- ATMP, Additional monitoring
- Application
- EMEA/H/C/002513
- ATC
- L03AX17
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.