European Medicines Agency Recommends a Variation to the Terms of the Marketing Authorisation for Palonosetron

New indication concerns prevention of acute nausea and vomiting associated with highly and moderately emetogenic chemotherapy in paediatric patients

On 22 January 2015, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product palonosetron (Aloxi).

The marketing authorisation holder for this medicinal product is Helsinn Birex Pharmaceuticals. They may request a re-examination of the CHMP opinion, provided that they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.

The CHMP adopted a new indication as follows:

Aloxi is indicated in paediatric patients 1 month of age and older for the prevention of acute nausea and vomiting associated with highly emetogenic chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic chemotherapy.

Detailed conditions for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.

The European Commission granted a marketing authorisation valid throughout the European Union for palonosetron on 22 March 2005 to prevent nausea and vomiting caused by chemotherapy in adult patients.