- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 8 April 2019, the marketing authorisation of Palonosetron Hospira (palonosetron) ceased to be valid in the European Union (EU). The cessation of validity is due to the fact that the marketing authorisation holder, Pfizer Europe MA EEIG, had not marketed Palonosetron Hospira in the EU since its initial marketing authorisation. In accordance with provisions of the sunset clause1, the marketing authorisation of the medicinal product lapsed as the product had not been marketed in any of the EU Member States within three years of its initial authorisation.
Pfizer Europe MA EEIG confirmed that the product had not been marketed due to commercial reasons. Palonosetron Hospira was granted marketing authorisation in the EU on 8 April 2016 for prevention of nausea and vomiting associated with cancer chemotherapy. The marketing authorisation was initially valid for a 5-year period.
Palonosetron Hospira is a generic medicine of Aloxi. There are other generic medicinal products of Aloxi authorised and marketed in the EU.
The European Public Assessment Report (EPAR) for Palonosetron Hospira is updated to indicate that the marketing authorisation is no longer valid.
Product information
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Palonosetron Hospira
- Active substance
- palonosetron hydrochloride
- International non-proprietary name (INN) or common name
- palonosetron
- Therapeutic area (MeSH)
- Nausea
- Vomiting
- Cancer
- Anatomical therapeutic chemical (ATC) code
- A04AA05
Pharmacotherapeutic group
Antiemetics and antinauseantsTherapeutic 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.