Palonosetron Accord

Authorised

This medicine is authorised for use in the European Union

palonosetron

Overview

This is a summary of the European public assessment report (EPAR) for Palonosetron Accord. 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 Accord.

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

What is Palonosetron Accord and what is it used for?

Palonosetron Accord is a medicine 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 Accord contains the active substance palonosetron. It is a ‘generic medicine’. This means that Palonosetron Accord is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Aloxi.

How is Palonosetron Accord used?

Palonosetron Accord should only be given before chemotherapy. It is available as a solution for injection or infusion (drip) into a vein, 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 into a vein over 15 minutes at a dose of 20 micrograms per kilogram body weight.

The medicine can only be obtained with a prescription.

How does Palonosetron Accord work?

The active substance in Palonosetron Accord, 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 Accord prevents the nausea and vomiting that often happen after chemotherapy.

How has Palonosetron Accord been studied?

The company provided data from the published literature on palonosetron. No additional studies were needed as Palonosetron Accord 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 Accord?

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

Why is Palonosetron Accord approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Palonosetron Accord 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 Accord be approved for use in the EU.

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

A risk management plan has been developed to ensure that Palonosetron Accord 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 Accord, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Palonosetron Accord

The European Commission granted a marketing authorisation valid throughout the European Union for Palonosetron Accord on 26 May 2016.

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

Palonosetron Accord : EPAR - Summary for the public

Reference Number: EMA/243539/2016

Product information

Palonosetron Accord : EPAR - Product Information

Latest procedure affecting product information: IA/0010

10/01/2022

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).

Palonosetron Accord : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Palonosetron Accord
• Active substance:
  Palonosetron
• International non-proprietary name (INN) or common name:
  palonosetron
• Therapeutic area (MeSH):
  • Vomiting
  • Nausea
  • Cancer
• Anatomical therapeutic chemical (ATC) code:
  A04AA05

Pharmacotherapeutic group

Antiemetics and antinauseants

Therapeutic indication

Palonosetron Accord 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 Accord 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/004129
• 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:
  Accord Healthcare S.L.U.

  Edificio Este Planta 6a; World Trade Center; Moll De Barcelona S/n; 08039 Barcelona; SPAIN

• Opinion adopted:
  31/03/2016
• Marketing authorisation issued:
  26/05/2016
• Revision:
  5

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Palonosetron Accord : EPAR - Public assessment report

AdoptedReference Number: EMA/287566/2016

CHMP summary of opinion for Palonosetron Accord

AdoptedReference Number: EMA/CHMP/220588/2016