Palonosetron Hospira

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palonosetron

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

 The marketing authorisation of Palonosetron Hospira has been withdrawn at the request of the marketing authorisation holder.

 

This EPAR was last updated on 08/04/2022

Authorisation details

Product details
Name
Palonosetron Hospira
Agency product number
EMEA/H/C/004069
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
GenericGeneric

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.

Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
08/04/2016
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

12/12/2018 Palonosetron Hospira - EMEA/H/C/004069 - IAIN/0005/G

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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.

Assessment history

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