Cytopoint

lokivetmab

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

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

What is Cytopoint and what is it used for?

Cytopoint is a veterinary medicine used to treat atopic dermatitis in dogs. Atopic dermatitis is inflammation of the skin that is linked to allergy, often to things in the environment such as house dust mites and pollens. Once the dog’s skin becomes damaged by scratching and rubbing, secondary bacterial and yeast infections may develop as well. Cytopoint contains the active substance lokivetmab.

How is Cytopoint used?

Cytopoint is available as a solution for injection that is injected under the skin once a month. The dose to be used depends on the weight of the dog being treated. Cytopoint starts to be effective within eight hours of injection and the effect lasts for up to 28 days. The medicine can only be obtained with a prescription.

For further information, see the package leaflet.

How does Cytopoint work?

Lokivetmab is a monoclonal antibody (a type of protein) that recognises and attaches to interleukin-31, a protein that plays an important role in triggering atopic dermatitits in dogs. By blocking interleukin 31, lokivetmab reduces itchy skin and inflammation.

What benefits of Cytopoint have been shown in studies?

In a field study involving dogs with atopic dermatitis, 142 dogs received Cytopoint monthly for 3 months whilst 132 were treated with ciclosporin, another medicine approved for treating atopic dermatitis. Cytopoint was as effective as ciclosporin in treating itchy skin; after 28 days the pruritus score (measurement of itchiness) was reduced by 52% in dogs given Cytopoint and 44% in those given ciclosporin. Over the three months of the study pruritus score went down from a value of 74 at the start to 26 at the end in dogs given Cytopoint. In a follow up study, 81 dogs of the dogs continued Cytopoint treatment for a further six months and the itchy skin score went down further to 14.

What are the risks associated with Cytopoint?

The most common side effects with Cytopoint (which may affect up to 1 in 1,000 animals) are allergic reactions with swelling of the face and itchy rash.

Cytopoint must not be given to dogs weighing less than 3 kg. For the full list of restrictions and all side effects reported with Cytopoint, see the package leaflet.

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 Cytopoint, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.

In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor. Repeated accidental self-injection may cause an allergic reaction to the medicine.

Why is Cytopoint approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Cytopoint’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Other information about Cytopoint

The European Commission granted a marketing authorisation valid throughout the EU for Cytopoint on 25 April 2017.

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

Name Language First published Last updated
Cytopoint : EPAR - Summary for the public BG = bălgarski 2017-05-05  
Cytopoint : EPAR - Summary for the public ES = español 2017-05-05  
Cytopoint : EPAR - Summary for the public CS = čeština 2017-05-05  
Cytopoint : EPAR - Summary for the public DA = dansk 2017-05-05  
Cytopoint : EPAR - Summary for the public DE = Deutsch 2017-05-05  
Cytopoint : EPAR - Summary for the public ET = eesti keel 2017-05-05  
Cytopoint : EPAR - Summary for the public EL = elliniká 2017-05-05  
Cytopoint : EPAR - Summary for the public EN = English 2017-05-05  
Cytopoint : EPAR - Summary for the public FR = français 2017-05-05  
Cytopoint : EPAR - Summary for the public IT = italiano 2017-05-05  
Cytopoint : EPAR - Summary for the public LV = latviešu valoda 2017-05-05  
Cytopoint : EPAR - Summary for the public LT = lietuvių kalba 2017-05-05  
Cytopoint : EPAR - Summary for the public HU = magyar 2017-05-05  
Cytopoint : EPAR - Summary for the public MT = Malti 2017-05-05  
Cytopoint : EPAR - Summary for the public NL = Nederlands 2017-05-05  
Cytopoint : EPAR - Summary for the public PL = polski 2017-05-05  
Cytopoint : EPAR - Summary for the public PT = português 2017-05-05  
Cytopoint : EPAR - Summary for the public RO = română 2017-05-05  
Cytopoint : EPAR - Summary for the public SK = slovenčina 2017-05-05  
Cytopoint : EPAR - Summary for the public SL = slovenščina 2017-05-05  
Cytopoint : EPAR - Summary for the public FI = suomi 2017-05-05  
Cytopoint : EPAR - Summary for the public SV = svenska 2017-05-05  
Cytopoint : EPAR - Summary for the public HR = Hrvatski 2017-05-05  

This EPAR was last updated on 05/05/2017 .

Authorisation details

Product details

Product details for Cytopoint
NameCytopoint
Agency product numberEMEA/V/C/003939
Active substance

lokivetmab

International non-proprietary name (INN) or common name

lokivetmab

Species Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes QD11AH91


Publication details

Publication details for Cytopoint
Marketing-authorisation holder

Zoetis Belgium SA

Revision0
Date of issue of marketing authorisation valid throughout the European Union25/04/2017

Contact address:

Zoetis Belgium SA
Rue Laid Burniat 
1 1348 Louvain-la-Neuve 
Belgium

Product information

Product information

25/04/2017  Cytopoint -EMEA/V/C/003939

Name Language First published Last updated
Cytopoint : EPAR - Product Information HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - Product Information HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - Product Information HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - Product Information HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - Product Information HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - Product Information HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - Product Information HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - Product Information HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - Product Information HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - Product Information HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - Product Information HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - Product Information HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - Product Information HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - Product Information HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - Product Information HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - Product Information HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - Product Information HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - Product Information HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - Product Information HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - Product Information HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - Product Information HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - Product Information HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - Product Information HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - Product Information HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - Product Information HR = Hrvatski 2017-05-05  

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
Cytopoint : EPAR - All Authorised presentations HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - All Authorised presentations HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - All Authorised presentations HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - All Authorised presentations HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - All Authorised presentations HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - All Authorised presentations HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - All Authorised presentations HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - All Authorised presentations HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - All Authorised presentations HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - All Authorised presentations HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - All Authorised presentations HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - All Authorised presentations HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - All Authorised presentations HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - All Authorised presentations HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - All Authorised presentations HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - All Authorised presentations HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - All Authorised presentations HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - All Authorised presentations HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - All Authorised presentations HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - All Authorised presentations HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - All Authorised presentations HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - All Authorised presentations HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - All Authorised presentations HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - All Authorised presentations HR = Hrvatski 2017-05-05  
Cytopoint : EPAR - All Authorised presentations HR = Hrvatski 2017-05-05  

Pharmacotherapeutic group

Other dermatological preparations, agents for dermatitis excluding corticosteroids

Therapeutic indication

Treatment of clinical manifestations of atopic dermatitis in dogs.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Cytopoint : EPAR - Public assessment report HR = Hrvatski 2017-05-05  
CVMP summary of positive opinion for Cytopoint HR = Hrvatski 2017-02-17