🇪🇺 Palonosetron only in European Union

EMA authorised Palonosetron only on 8 April 2016

Marketing authorisations

Application: EMEA/H/C/004069
Marketing authorisation holder: Pfizer Europe MA EEIG
Local brand name: Palonosetron Hospira
Indication: Palonosetron Hospira is indicated in adults for: the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy; the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. Palonosetron Hospira is indicated in paediatric patients 1 month of age and older for: the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Status: withdrawn

Application: EMEA/H/C/004129
Marketing authorisation holder: Accord Healthcare S.L.U.
Local brand name: Palonosetron Accord
Indication: Palonosetron Accord is indicated in adults for: the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy, the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. Palonosetron Accord is indicated in paediatric patients 1 month of age and older for: The prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Status: approved

Is Palonosetron only approved in European Union?

Yes. EMA authorised it on 8 April 2016; EMA authorised it on 26 May 2016.

Who is the marketing authorisation holder for Palonosetron only in European Union?

Pfizer Europe MA EEIG holds the EU marketing authorisation.