This is a summary of the European public assessment report (EPAR) for Palonosetron Accord. 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 Palonosetron Accord.
For practical information about using Palonosetron Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Palonosetron Accord : EPAR - Summary for the public (PDF/169.3 KB)
First published: 08/06/2016
Last updated: 08/06/2016
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This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.
Accord Healthcare S.L.U.
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01/03/2019 Palonosetron Accord - EMEA/H/C/004129 - T/0004
- 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.
Antiemetics and antinauseants
Palonosetron Accord is indicated in adults for:
- the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy,
- the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Palonosetron Accord is indicated in paediatric patients 1 month of age and older for:
- The prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.