This is a summary of the European public assessment report (EPAR) for Jevtana. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Jevtana.
Jevtana : EPAR - Summary for the public (PDF/78.05 KB)
First published: 05/04/2011
Last updated: 05/05/2017
Jevtana : EPAR - Risk-management-plan summary (PDF/38.55 KB)
First published: 17/12/2020
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54, rue la Boétie
13/12/2021 Jevtana - EMEA/H/C/002018 - N/0046
This medicine’s product information is available in all official EU languages.
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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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Jevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.