Akynzeo

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netupitant / palonosetron

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

Overview

This is a summary of the European public assessment report (EPAR) for Akynzeo. 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 Akynzeo.

For practical information about using Akynzeo, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 10/07/2019

Authorisation details

Product details
Name
Akynzeo
Agency product number
EMEA/H/C/003728
Active substance
  • netupitant
  • palonosetron hydrochloride
International non-proprietary name (INN) or common name
netupitant / palonosetron
Therapeutic area (MeSH)
  • Vomiting
  • Cancer
  • Nausea
Anatomical therapeutic chemical (ATC) code
A04AA
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Helsinn Birex Pharmaceuticals Ltd
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
27/05/2015
Contact address
Damastown
Mulhuddart
15 Dublin
Ireland

Product information

11/06/2019 Akynzeo - EMEA/H/C/003728 - N/0023

Contents

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

Pharmacotherapeutic group

Antiemetics and antinauseants

Therapeutic indication

Akynzeo is indicated in adults for the:

  • Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy.
  • Prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Assessment history

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