This is a summary of the European public assessment report (EPAR) for Sancuso. 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 Sancuso.
Sancuso : EPAR - Summary for the public (PDF/57.72 KB)
First published: 08/05/2012
Last updated: 08/05/2012
Sancuso : EPAR - Risk-management-plan summary (PDF/39.29 KB)
First published: 16/06/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Kyowa Kirin Holdings B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
30/04/2020 Sancuso - EMEA/H/C/002296 - II/0056/G
- 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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Antiemetics and antinauseants
Serotonin (5HT3) antagonists
Prevention of nausea and vomiting in patients receiving moderately or highly emetogenic chemotherapy, with or without cisplatin, for up to five consecutive days.
Sancuso may be used in patients receiving their first chemotherapy regimen or in patients who have previously received chemotherapy.