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
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22/01/2018 Jevtana - EMEA/H/C/002018 - N/0039
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.