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Withdrawn

This medicine's authorisation has been withdrawn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)

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The marketing authorisation for Provenge has been withdrawn at the request of the marketing authorisation holder.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

Product information

Provenge : EPAR - Product Information

06/05/2015

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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

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 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.

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

Changes since initial authorisation of medicine

Provenge : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Provenge : EPAR - Public assessment report

AdoptedReference Number: EMA/440011/2013

CHMP summary of positive opinion for Provenge

AdoptedReference Number: EMA/CHMP/363851/2013