Akynzeo

netupitant / palonosetron

Table of contents

Opinion

On 12 December 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Akynzeo (fixed combination of fosnetupitant [pro-drug of netupitant] and palonosetron). The marketing authorisation holder for this medicinal product is Helsinn Birex Pharmaceuticals Limited.

The CHMP adopted a new pharmaceutical form associated with a new strength and a new route of administration as follows:

Akynzeo 235 mg/0.25 mg powder for concentrate for solution for infusion for intravenous use   

For information, the full presentations for Akynzeo will be as follows:

Akynzeo 300 mg / 0.50 mg hard capsule, for oral use

Akynzeo 235 mg / 0.25 mg powder for concentrate for solution for infusion for intravenous use

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

Key facts

Name
Akynzeo
Agency product number
EMEA/H/C/003728
International non-proprietary name (INN) or common name
  • netupitant / palonosetron
Active substance
  • netupitant
  • palonosetron hydrochloride
Therapeutic area
Vomiting
Cancer
Nausea
Date opinion adopted
12/12/2019
Company name
Helsinn Birex Pharmaceuticals Ltd
Status
Positive
Application type
Initial authorisation

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