Palonosetron Hospira

palonosetron

  • Email
  • Help

About

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.

What is Palonosetron Hospira and what is it used for?

Palonosetron Hospira is used to prevent nausea (feeling sick) and vomiting caused by chemotherapy (medicines to treat cancer). It is used in adults and children 1 month of age or older for chemotherapy with medicines that are either a strong trigger of nausea and vomiting (such as cisplatin) or a moderate trigger (such as cyclophosphamide, doxorubicin or carboplatin).

Palonosetron Hospira is a ‘generic medicine’. This means that Palonosetron Hospira is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Aloxi. 

Palonosetron Hospira contains the active substance palonosetron.

How is Palonosetron Hospira used?

Palonosetron Hospira should only be given before chemotherapy and can only be obtained with a prescription. It is available as a solution for injection which should be given by a healthcare professional about 30 minutes before the start of chemotherapy. In adults, the recommended dose is 250 micrograms, injected into a vein over 30 seconds. It may be given with a corticosteroid (another type of medicine that can be used to prevent nausea and vomiting) to increase the effect. In children, the solution should be given by infusion (drip) into a vein over 15 minutes at a dose of 20 micrograms per kilogram body weight.

How does Palonosetron Hospira work?

The active substance in Palonosetron Hospira, palonosetron, is a ‘5HT3 antagonist’. This means that it stops a chemical in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from attaching to 5HT3 receptors in the gut. When 5HT attaches to these receptors, it normally causes nausea and vomiting. By blocking these receptors, Palonosetron Hospira prevents the nausea and vomiting that often happen after chemotherapy.

How has Palonosetron Hospira been studied?

The company provided data from the published literature on palonosetron. No additional studies were needed as Palonosetron Hospira is a generic medicine that is given by injection and contains the same active substance as the reference medicine, Aloxi.

What are the benefits and risks of Palonosetron Hospira?

Because Palonosetron Hospira is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Palonosetron Hospira approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Palonosetron Hospira has been shown to be comparable to Aloxi. Therefore, the CHMP’s view was that, as for Aloxi, the benefit outweighs the identified risk. The Committee recommended that Palonosetron Hospira be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Palonosetron Hospira?

A risk management plan has been developed to ensure that Palonosetron Hospira is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Palonosetron Hospira, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Palonosetron Hospira

The European Commission granted a marketing authorisation valid throughout the European Union for Palonosetron Hospira on 8 April 2016.

For more information about treatment with Palonosetron Hospira, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Palonosetron Hospira : EPAR - Summary for the public BG = bălgarski 2016-04-21  
Palonosetron Hospira : EPAR - Summary for the public ES = español 2016-04-21  
Palonosetron Hospira : EPAR - Summary for the public CS = čeština 2016-04-21  
Palonosetron Hospira : EPAR - Summary for the public DA = dansk 2016-04-21  
Palonosetron Hospira : EPAR - Summary for the public DE = Deutsch 2016-04-21  
Palonosetron Hospira : EPAR - Summary for the public ET = eesti keel 2016-04-21  
Palonosetron Hospira : EPAR - Summary for the public EL = elliniká 2016-04-21  
Palonosetron Hospira : EPAR - Summary for the public EN = English 2016-04-21  
Palonosetron Hospira : EPAR - Summary for the public FR = français 2016-04-21  
Palonosetron Hospira : EPAR - Summary for the public IT = italiano 2016-04-21  
Palonosetron Hospira : EPAR - Summary for the public LV = latviešu valoda 2016-04-21  
Palonosetron Hospira : EPAR - Summary for the public LT = lietuvių kalba 2016-04-21  
Palonosetron Hospira : EPAR - Summary for the public HU = magyar 2016-04-21  
Palonosetron Hospira : EPAR - Summary for the public MT = Malti 2016-04-21  
Palonosetron Hospira : EPAR - Summary for the public NL = Nederlands 2016-04-21  
Palonosetron Hospira : EPAR - Summary for the public PL = polski 2016-04-21  
Palonosetron Hospira : EPAR - Summary for the public PT = português 2016-04-21  
Palonosetron Hospira : EPAR - Summary for the public RO = română 2016-04-21  
Palonosetron Hospira : EPAR - Summary for the public SK = slovenčina 2016-04-21  
Palonosetron Hospira : EPAR - Summary for the public SL = slovenščina 2016-04-21  
Palonosetron Hospira : EPAR - Summary for the public FI = suomi 2016-04-21  
Palonosetron Hospira : EPAR - Summary for the public SV = svenska 2016-04-21  
Palonosetron Hospira : EPAR - Summary for the public HR = Hrvatski 2016-04-21  

This EPAR was last updated on 08/03/2018 .

Authorisation details

Product details

Product details for Palonosetron Hospira
NamePalonosetron Hospira
Agency product numberEMEA/H/C/004069
Active substance

palonosetron hydrochloride

International non-proprietary name (INN) or common name

palonosetron

Therapeutic area NauseaVomitingCancer
Anatomical therapeutic chemical (ATC) code A04AA05
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Palonosetron Hospira
Marketing-authorisation holder

Hospira UK Limited

Revision3
Date of issue of marketing authorisation valid throughout the European Union08/04/2016

Contact address:

Hospira UK Limited
Horizon
Honey Lane
Hurley SL6 6RJ
United Kingdom

Product information

Product information

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

Name Language First published Last updated
Palonosetron Hospira : EPAR - Product Information HR = Hrvatski 2016-04-21 2018-03-08
Palonosetron Hospira : EPAR - Product Information HR = Hrvatski 2016-04-21 2018-03-08
Palonosetron Hospira : EPAR - Product Information HR = Hrvatski 2016-04-21 2018-03-08
Palonosetron Hospira : EPAR - Product Information HR = Hrvatski 2016-04-21 2018-03-08
Palonosetron Hospira : EPAR - Product Information HR = Hrvatski 2016-04-21 2018-03-08
Palonosetron Hospira : EPAR - Product Information HR = Hrvatski 2016-04-21 2018-03-08
Palonosetron Hospira : EPAR - Product Information HR = Hrvatski 2016-04-21 2018-03-08
Palonosetron Hospira : EPAR - Product Information HR = Hrvatski 2016-04-21 2018-03-08
Palonosetron Hospira : EPAR - Product Information HR = Hrvatski 2016-04-21 2018-03-08
Palonosetron Hospira : EPAR - Product Information HR = Hrvatski 2016-04-21 2018-03-08
Palonosetron Hospira : EPAR - Product Information HR = Hrvatski 2016-04-21 2018-03-08
Palonosetron Hospira : EPAR - Product Information HR = Hrvatski 2016-04-21 2018-03-08
Palonosetron Hospira : EPAR - Product Information HR = Hrvatski 2016-04-21 2018-03-08
Palonosetron Hospira : EPAR - Product Information HR = Hrvatski 2016-04-21 2018-03-08
Palonosetron Hospira : EPAR - Product Information HR = Hrvatski 2016-04-21 2018-03-08
Palonosetron Hospira : EPAR - Product Information HR = Hrvatski 2016-04-21 2018-03-08
Palonosetron Hospira : EPAR - Product Information HR = Hrvatski 2016-04-21 2018-03-08
Palonosetron Hospira : EPAR - Product Information HR = Hrvatski 2016-04-21 2018-03-08
Palonosetron Hospira : EPAR - Product Information HR = Hrvatski 2016-04-21 2018-03-08
Palonosetron Hospira : EPAR - Product Information HR = Hrvatski 2016-04-21 2018-03-08
Palonosetron Hospira : EPAR - Product Information HR = Hrvatski 2016-04-21 2018-03-08
Palonosetron Hospira : EPAR - Product Information HR = Hrvatski 2016-04-21 2018-03-08
Palonosetron Hospira : EPAR - Product Information HR = Hrvatski 2016-04-21 2018-03-08
Palonosetron Hospira : EPAR - Product Information HR = Hrvatski 2016-04-21 2018-03-08
Palonosetron Hospira : EPAR - Product Information HR = Hrvatski 2016-04-21 2018-03-08

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.


Name Language First published Last updated
Palonosetron Hospira : EPAR - All Authorised presentations HR = Hrvatski 2016-04-21  
Palonosetron Hospira : EPAR - All Authorised presentations HR = Hrvatski 2016-04-21  
Palonosetron Hospira : EPAR - All Authorised presentations HR = Hrvatski 2016-04-21  
Palonosetron Hospira : EPAR - All Authorised presentations HR = Hrvatski 2016-04-21  
Palonosetron Hospira : EPAR - All Authorised presentations HR = Hrvatski 2016-04-21  
Palonosetron Hospira : EPAR - All Authorised presentations HR = Hrvatski 2016-04-21  
Palonosetron Hospira : EPAR - All Authorised presentations HR = Hrvatski 2016-04-21  
Palonosetron Hospira : EPAR - All Authorised presentations HR = Hrvatski 2016-04-21  
Palonosetron Hospira : EPAR - All Authorised presentations HR = Hrvatski 2016-04-21  
Palonosetron Hospira : EPAR - All Authorised presentations HR = Hrvatski 2016-04-21  
Palonosetron Hospira : EPAR - All Authorised presentations HR = Hrvatski 2016-04-21  
Palonosetron Hospira : EPAR - All Authorised presentations HR = Hrvatski 2016-04-21  
Palonosetron Hospira : EPAR - All Authorised presentations HR = Hrvatski 2016-04-21  
Palonosetron Hospira : EPAR - All Authorised presentations HR = Hrvatski 2016-04-21  
Palonosetron Hospira : EPAR - All Authorised presentations HR = Hrvatski 2016-04-21  
Palonosetron Hospira : EPAR - All Authorised presentations HR = Hrvatski 2016-04-21  
Palonosetron Hospira : EPAR - All Authorised presentations HR = Hrvatski 2016-04-21  
Palonosetron Hospira : EPAR - All Authorised presentations HR = Hrvatski 2016-04-21  
Palonosetron Hospira : EPAR - All Authorised presentations HR = Hrvatski 2016-04-21  
Palonosetron Hospira : EPAR - All Authorised presentations HR = Hrvatski 2016-04-21  
Palonosetron Hospira : EPAR - All Authorised presentations HR = Hrvatski 2016-04-21  
Palonosetron Hospira : EPAR - All Authorised presentations HR = Hrvatski 2016-04-21  
Palonosetron Hospira : EPAR - All Authorised presentations HR = Hrvatski 2016-04-21  

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Palonosetron Hospira : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2017-03-09 2018-03-08

Initial marketing-authorisation documents

Name Language First published Last updated
Palonosetron Hospira : EPAR - Public assessment report HR = Hrvatski 2016-04-21  
CHMP summary of opinion for Palonosetron Hospira HR = Hrvatski 2016-02-26  

Authorised

This medicine is approved for use in the European Union

More information on Palonosetron Hospira

Related information