This is a summary of the European public assessment report (EPAR) for Kisplyx. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Kisplyx.
For practical information about using Kisplyx, patients should read the package leaflet or contact their doctor or pharmacist.
Kisplyx : EPAR - Summary for the public (PDF/77.46 KB)
First published: 16/11/2016
Last updated: 16/11/2016
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Carcinoma, Renal Cell
|Anatomical therapeutic chemical (ATC) code||
Eisai Europe Ltd
|Date of issue of marketing authorisation valid throughout the European Union||
25/10/2018 Kisplyx - EMEA/H/C/004224 - WS/1444
- 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
Please note that the size of the above document can exceed 50 pages.
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In combination with everolimus for the treatment of unresectable advanced or metastatic renal cell carcinoma.