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EMA Product

Palonosetron Accord

Product approved by European Medicines Agency (EU)

Basic Information

Palonosetron Accord

Regulatory Information

EMEA/H/C/004129

Authorised

May 26, 2016

March 31, 2016

8

July 19, 2024

Company Information

Spain

Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona

ACCORD HEALTHCARE SL

Drug Classification

Generic Medicine

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication 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.

Overview Summary

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.

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