The European Commission approves Aloxi (palonosetron hydrochloride) injection to prevent nausea and vomiting due to chemotherapy in children as young as one month

EMA

Helsinn Group, the Swiss Group focused on building quality cancer care, today announces that the European Commission has endorsed the Committee for Medicinal Products for Human Use’s (CHMP) Opinion recommending the approval of Aloxi (palonosetron hydrochloride) injection for the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy, in paediatric patients one month of age and older.

This is the first European approval of a product for the prevention of acute chemotherapy-induced nausea and vomiting (CINV) in children aged one to six months. Since the childhood cancer incidence tends to be higher within the first 3 years of life, this approval offers an important therapeutic option to children, and especially young infants, undergoing cancer chemotherapy.

Since its implementation, the European Paediatric Regulation has substantially increased the availability in Europe of high quality, ethically-researched medicines for use in children.

For more details, go to: http://www.helsinn.com/news/the-european-commission-approves-aloxi-palonosetron-hcl-injection-to-prevent-nausea-and-vomiting-due-to-chemotherapy-in-children-as-young-as-one-mo/

Michael Wonder

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Michael Wonder

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