Prevomax

maropitant

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

For practical information about using Prevomax, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

What is Prevomax and what is it used for?

Prevomax is a veterinary medicine used in dogs and cats to treat vomiting, in combination with other supportive measures, or to prevent vomiting (except travel sickness).

In cats Prevomax is also used to reduce nausea (signs of feeling sick).

In dogs Prevomax can also be used both to prevent nausea and vomiting before and after an operation and to improve recovery from general anaesthesia after use of morphine. Prevomax is also used to prevent and treat nausea caused by chemotherapy in dogs.

Prevomax contains the active substance maropitant.

Prevomax is a ‘generic medicine’. This means that Prevomax contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Cerenia.

How is Prevomax used?

The medicine can only be obtained with a prescription and is available as a solution for injection. Prevomax is injected once daily under the skin or into a vein (1 mg/per kg bodyweight) for up to five days. To prevent vomiting Prevomax should be given more than one hour in advance of the event that might cause vomiting.

For further information, see the package leaflet.

How does Prevomax work?

The active substance in Prevomax, maropitant, stops a chemical in the body (substance P) from attaching to certain targets called neurokinin-1 (NK1) receptors, which are found on the surface of cells in the part of the brain that controls nausea and vomiting. When substance P attaches to these receptors it triggers nausea and vomiting. By blocking the receptors, maropitant can prevent nausea and vomiting.

How has Prevomax been studied?

Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Cerenia, and do not need to be repeated for Prevomax.

As for every medicine, the company provided studies on the quality of Prevomax. There was no need for ‘bioequivalence’ studies to investigate whether Prevomax is absorbed similarly to the reference medicine, Cerenia solution for injection, to produce the same level of the active substance in the blood. This is because when given by injection into a vein, the active substance in Prevomax is delivered straight into the bloodstream. When given by injection under the skin, the active substance in Prevomax is expected to be absorbed in the same way as the reference medicine.

What are the benefits and risks of Prevomax?

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

What are the precautions for the person who gives the medicine or comes into contact with the animal?

Safety information has been included in the summary of product characteristics and the package leaflet for Prevomax, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers. The precautions are the same as for the reference medicine since Prevomax is a generic medicine.

Why is Prevomax approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Prevomax has been shown to have comparable quality and to be bioequivalent to Cerenia, solution for injection. Therefore, the CVMP’s view was that, as for Cerenia, the benefits outweigh the identified risks. The Committee recommended that Prevomax be approved for use in the EU.

Other information about Prevomax?

The European Commission granted a marketing authorisation valid throughout the EU for Prevomax on 19 June 2017.

For more information about treatment with Prevomax, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

Name Language First published Last updated
Prevomax : EPAR - Summary for the public BG = bălgarski 2017-07-06  
Prevomax : EPAR - Summary for the public ES = español 2017-07-06  
Prevomax : EPAR - Summary for the public CS = čeština 2017-07-06  
Prevomax : EPAR - Summary for the public DA = dansk 2017-07-06  
Prevomax : EPAR - Summary for the public DE = Deutsch 2017-07-06  
Prevomax : EPAR - Summary for the public ET = eesti keel 2017-07-06  
Prevomax : EPAR - Summary for the public EL = elliniká 2017-07-06  
Prevomax : EPAR - Summary for the public EN = English 2017-07-06  
Prevomax : EPAR - Summary for the public FR = français 2017-07-06  
Prevomax : EPAR - Summary for the public IT = italiano 2017-07-06  
Prevomax : EPAR - Summary for the public LV = latviešu valoda 2017-07-06  
Prevomax : EPAR - Summary for the public LT = lietuvių kalba 2017-07-06  
Prevomax : EPAR - Summary for the public HU = magyar 2017-07-06  
Prevomax : EPAR - Summary for the public MT = Malti 2017-07-06  
Prevomax : EPAR - Summary for the public NL = Nederlands 2017-07-06  
Prevomax : EPAR - Summary for the public PL = polski 2017-07-06  
Prevomax : EPAR - Summary for the public PT = português 2017-07-06  
Prevomax : EPAR - Summary for the public RO = română 2017-07-06  
Prevomax : EPAR - Summary for the public SK = slovenčina 2017-07-06  
Prevomax : EPAR - Summary for the public SL = slovenščina 2017-07-06  
Prevomax : EPAR - Summary for the public FI = suomi 2017-07-06  
Prevomax : EPAR - Summary for the public SV = svenska 2017-07-06  
Prevomax : EPAR - Summary for the public HR = Hrvatski 2017-07-06  

This EPAR was last updated on 06/07/2017 .

Authorisation details

Product details

Product details for Prevomax
NamePrevomax
Agency product numberEMEA/V/C/004331
Active substance

maropitant

International non-proprietary name (INN) or common name

maropitant

Species DogsCats
Anatomical therapeutic chemical veterinary (ATCvet) codes QA04AD90



Publication details

Publication details for Prevomax
Marketing-authorisation holder

Le Vet Beheer B.V.

Revision0
Date of issue of marketing authorisation valid throughout the European Union19/06/2017

Contact address:

Le Vet Beheer B.V.
Wilgenweg 7 
3421 TV Oudewater
The Netherlands

Product information

Product information

19/06/2017  Prevomax -EMEA/V/C/004331

Name Language First published Last updated
Prevomax : EPAR - Product Information HR = Hrvatski 2017-07-06  
Prevomax : EPAR - Product Information HR = Hrvatski 2017-07-06  
Prevomax : EPAR - Product Information HR = Hrvatski 2017-07-06  
Prevomax : EPAR - Product Information HR = Hrvatski 2017-07-06  
Prevomax : EPAR - Product Information HR = Hrvatski 2017-07-06  
Prevomax : EPAR - Product Information HR = Hrvatski 2017-07-06  
Prevomax : EPAR - Product Information HR = Hrvatski 2017-07-06  
Prevomax : EPAR - Product Information HR = Hrvatski 2017-07-06  
Prevomax : EPAR - Product Information HR = Hrvatski 2017-07-06  
Prevomax : EPAR - Product Information HR = Hrvatski 2017-07-06  
Prevomax : EPAR - Product Information HR = Hrvatski 2017-07-06  
Prevomax : EPAR - Product Information HR = Hrvatski 2017-07-06  
Prevomax : EPAR - Product Information HR = Hrvatski 2017-07-06  
Prevomax : EPAR - Product Information HR = Hrvatski 2017-07-06  
Prevomax : EPAR - Product Information HR = Hrvatski 2017-07-06  
Prevomax : EPAR - Product Information HR = Hrvatski 2017-07-06  
Prevomax : EPAR - Product Information HR = Hrvatski 2017-07-06  
Prevomax : EPAR - Product Information HR = Hrvatski 2017-07-06  
Prevomax : EPAR - Product Information HR = Hrvatski 2017-07-06  
Prevomax : EPAR - Product Information HR = Hrvatski 2017-07-06  
Prevomax : EPAR - Product Information HR = Hrvatski 2017-07-06  
Prevomax : EPAR - Product Information HR = Hrvatski 2017-07-06  
Prevomax : EPAR - Product Information HR = Hrvatski 2017-07-06  
Prevomax : EPAR - Product Information HR = Hrvatski 2017-07-06  
Prevomax : EPAR - Product Information HR = Hrvatski 2017-07-06  

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
Prevomax : EPAR - All Authorised presentations HR = Hrvatski 2017-07-06  
Prevomax : EPAR - All Authorised presentations HR = Hrvatski 2017-07-06  
Prevomax : EPAR - All Authorised presentations HR = Hrvatski 2017-07-06  
Prevomax : EPAR - All Authorised presentations HR = Hrvatski 2017-07-06  
Prevomax : EPAR - All Authorised presentations HR = Hrvatski 2017-07-06  
Prevomax : EPAR - All Authorised presentations HR = Hrvatski 2017-07-06  
Prevomax : EPAR - All Authorised presentations HR = Hrvatski 2017-07-06  
Prevomax : EPAR - All Authorised presentations HR = Hrvatski 2017-07-06  
Prevomax : EPAR - All Authorised presentations HR = Hrvatski 2017-07-06  
Prevomax : EPAR - All Authorised presentations HR = Hrvatski 2017-07-06  
Prevomax : EPAR - All Authorised presentations HR = Hrvatski 2017-07-06  
Prevomax : EPAR - All Authorised presentations HR = Hrvatski 2017-07-06  
Prevomax : EPAR - All Authorised presentations HR = Hrvatski 2017-07-06  
Prevomax : EPAR - All Authorised presentations HR = Hrvatski 2017-07-06  
Prevomax : EPAR - All Authorised presentations HR = Hrvatski 2017-07-06  
Prevomax : EPAR - All Authorised presentations HR = Hrvatski 2017-07-06  
Prevomax : EPAR - All Authorised presentations HR = Hrvatski 2017-07-06  
Prevomax : EPAR - All Authorised presentations HR = Hrvatski 2017-07-06  
Prevomax : EPAR - All Authorised presentations HR = Hrvatski 2017-07-06  
Prevomax : EPAR - All Authorised presentations HR = Hrvatski 2017-07-06  
Prevomax : EPAR - All Authorised presentations HR = Hrvatski 2017-07-06  
Prevomax : EPAR - All Authorised presentations HR = Hrvatski 2017-07-06  
Prevomax : EPAR - All Authorised presentations HR = Hrvatski 2017-07-06  
Prevomax : EPAR - All Authorised presentations HR = Hrvatski 2017-07-06  
Prevomax : EPAR - All Authorised presentations HR = Hrvatski 2017-07-06  

Pharmacotherapeutic group

Alimentary tract and metabolism; Other antiemetics

Therapeutic indication

Dogs:

  • For the treatment and prevention of nausea induced by chemotherapy
  • For the prevention of vomiting except that induced by motion sickness
  • For the treatment of vomiting, in combination with other supportive measures
  • For the prevention of perioperative nausea and vomiting and improvement in recovery from general anaesthesia after use of the μ-opiate receptor agonist morphine

Cats:

  • For the prevention of vomiting and the reduction of nausea, except that induced by motion sickness
  • For the treatment of vomiting, in combination with other supportive measures.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Prevomax : EPAR - Public assessment report HR = Hrvatski 2017-07-06  
CVMP summary of positive opinion for Prevomax HR = Hrvatski 2017-04-18  

Authorised

This medicine is approved for use in the European Union