Palonosetron Hospira

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palonosetron

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Palonosetron Hospira. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Palonosetron Hospira.

For practical information about using Palonosetron Hospira, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 08/03/2018

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
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 medicines.

Publication details
Marketing-authorisation holder
Hospira UK Limited
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
08/04/2016
Contact address
Horizon
Honey Lane
Hurley SL6 6RJ
United Kingdom

Product information

01/02/2018 Palonosetron Hospira - EMEA/H/C/004069 - IAIN/0003

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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