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.
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.
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