Akynzeo

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netupitant / palonosetron

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

Overview

Akynzeo is a medicine used to prevent nausea (feeling sick) and vomiting in adults with cancer who are receiving chemotherapy (medicines to treat cancer).

Some chemotherapy is known to induce severe nausea and vomiting, and Akynzeo is used in patients receiving either highly emetogenic (vomit-inducing) chemotherapy containing the cancer medicine cisplatin, or other chemotherapies that are moderately emetogenic.

Akynzeo is available as capsules and as a powder to be made up into a solution for injection. It contains the active substances netupitant and palonosetron (capsules) or fosnetupitant and palonosetron (powder).

This EPAR was last updated on 09/11/2022

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
  • Neoplasms
  • Nausea
  • Cancer
Anatomical therapeutic chemical (ATC) code
A04AA
Publication details
Marketing-authorisation holder
Helsinn Birex Pharmaceuticals Ltd
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
27/05/2015
Contact address

Damastown
Mulhuddart
15 Dublin
Ireland

Product information

09/11/2022 Akynzeo - EMEA/H/C/003728 - N/0047

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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