Palonosetron Hospira

Withdrawn

This medicine's authorisation has been withdrawn

palonosetron

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Public Assessment Report (EPAR) for Palonosetron Hospira is updated to indicate that the marketing authorisation is no longer valid.

Palonosetron Hospira : EPAR - Summary for the public

Product information

Palonosetron Hospira : EPAR - Product Information

Palonosetron Hospira : EPAR - All Authorised presentations

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 antinauseants

Therapeutic 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.

Authorisation details

• EMA product number:
  EMEA/H/C/004069
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Pfizer Europe MA EEIG

  Boulevard de la Plaine 17; 1050 Bruxelles; Belgium

• Marketing authorisation issued:
  08/04/2016
• Revision:
  4

Assessment history

Changes since initial authorisation of medicine

Palonosetron Hospira : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Palonosetron Hospira : EPAR - Public assessment report

AdoptedReference Number: EMA/215640/2016

CHMP summary of opinion for Palonosetron Hospira

AdoptedReference Number: EMA/CHMP/131135/2016