Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Provenge   
Auth. number : EU/1/13/867
INN : Autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (Sipuleucel-T)
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L03 - Immunomodulating agents
Pharmacological subgroup: L03A - Immunostimulating agents
Chemical subgroup: L03AX - Other immunostimulating agents
Chemical substance: L03AX17 - Sipuleucel-T
(See WHO ATC Index)
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.
Marketing Authorisation Holder: Dendreon UK Limited
41 Chalton Street, London NW1 1JD, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
10/09/2013 Centralised - Authorisation EMEA/H/C/2513 (2013)5841 of 06/09/2013