Sancuso

RSS

granisetron

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 13/06/2019

Authorisation details

Product details
Name
Sancuso
Agency product number
EMEA/H/C/002296
Active substance
granisetron
International non-proprietary name (INN) or common name
granisetron
Therapeutic area (MeSH)
  • Vomiting
  • Cancer
Anatomical therapeutic chemical (ATC) code
A04AA02
Publication details
Marketing-authorisation holder
Kyowa Kirin Holdings B.V.
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
20/04/2012
Contact address

Bloemlaan 2
21 32NP Hoofddorp
The Netherlands

Product information

22/03/2019 Sancuso - EMEA/H/C/002296 - N/0055

Contents

  • 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.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Anti emetics and antinauseants

Therapeutic indication

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.

Assessment history

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