Galliprant

grapiprant

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

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

What is Galliprant and what is it used for?

Galliprant is a veterinary medicine. It is used in dogs to treat pain associated with mild to moderate osteoarthritis, a condition causing swelling and pain in the joints. It contains the active substance grapiprant.

How is Galliprant used?

Galliprant is available as tablets and can only be obtained with a prescription. It is given to dogs once daily on an empty stomach at least one hour before the next meal. The dose is based on the bodyweight of the dog and the length of treatment depends on the response. Intermittent treatment may be beneficial in some dogs as signs of osteoarthritis come and go.

For further information, see the package leaflet.

How does Galliprant work?

Galliprant contains grapiprant, a non-steroidal, non-cyclooxygenase inhibiting anti-inflammatory drug (NSAID), of the piprant class, that works in a different way from other NSAIDs, which block a range of cyclo-oxygenase enzymes. Grapiprant works by blocking a specific target receptor called EP4, through which natural substances called prostaglandins act to produce pain in osteoarthritis. By blocking EP4, grapiprant helps relieve the signs of the condition.

What benefits of Galliprant have been shown in studies?

Two field studies were conducted involving dogs mostly with mild to moderate osteoarthritis confirmed by radiography in at least one limb joint. In total, 51% of dogs (120 of 235) were treated successfully with Galliprant at 28 days after the start of the treatment. This compared to 36% of dogs receiving a dummy treatment (82 of 231). Success was assessed by the dog owners and by veterinarians, using scoring systems for pain severity, pain interference and overall life quality.

What are the risks associated with Galliprant?

The most common side effect with Galliprant (which may affect more than 1 in 10 animals) is mild and generally short-lived vomiting.

Galliprant must not be given to pregnant, lactating or breeding dogs.

For the full list of side effects and restrictions with Galliprant, see the package leaflet.

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

Hands should be washed after handling the medicine.

If the medicine is accidentally swallowed by a person, the advice of a doctor should be sought immediately. If swallowed by a child, mild and reversible gastrointestinal signs and nausea may be seen.

Why is Galliprant approved?

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

Other information about Galliprant?

The European Commission granted a marketing authorisation valid throughout the EU for Galliprant on 9 January 2018.

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

Name Language First published Last updated
Galliprant : EPAR - Summary for the public BG = bălgarski 2018-02-06  
Galliprant : EPAR - Summary for the public ES = español 2018-02-06  
Galliprant : EPAR - Summary for the public CS = čeština 2018-02-06  
Galliprant : EPAR - Summary for the public DA = dansk 2018-02-06  
Galliprant : EPAR - Summary for the public DE = Deutsch 2018-02-06  
Galliprant : EPAR - Summary for the public ET = eesti keel 2018-02-06  
Galliprant : EPAR - Summary for the public EL = elliniká 2018-02-06  
Galliprant : EPAR - Summary for the public EN = English 2018-02-06  
Galliprant : EPAR - Summary for the public FR = français 2018-02-06  
Galliprant : EPAR - Summary for the public IT = italiano 2018-02-06  
Galliprant : EPAR - Summary for the public LV = latviešu valoda 2018-02-06  
Galliprant : EPAR - Summary for the public LT = lietuvių kalba 2018-02-06  
Galliprant : EPAR - Summary for the public HU = magyar 2018-02-06  
Galliprant : EPAR - Summary for the public MT = Malti 2018-02-06  
Galliprant : EPAR - Summary for the public NL = Nederlands 2018-02-06  
Galliprant : EPAR - Summary for the public PL = polski 2018-02-06  
Galliprant : EPAR - Summary for the public PT = português 2018-02-06  
Galliprant : EPAR - Summary for the public RO = română 2018-02-06  
Galliprant : EPAR - Summary for the public SK = slovenčina 2018-02-06  
Galliprant : EPAR - Summary for the public SL = slovenščina 2018-02-06  
Galliprant : EPAR - Summary for the public FI = suomi 2018-02-06  
Galliprant : EPAR - Summary for the public SV = svenska 2018-02-06  
Galliprant : EPAR - Summary for the public HR = Hrvatski 2018-02-06  

This EPAR was last updated on 06/02/2018 .

Authorisation details

Product details

Product details for Galliprant
NameGalliprant
Agency product numberEMEA/V/C/004222
Active substance

grapiprant

International non-proprietary name (INN) or common name

grapiprant

Species Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes QM01AX92



Publication details

Publication details for Galliprant
Marketing-authorisation holder

Aratana Therapeutics NV

Revision0
Date of issue of marketing authorisation valid throughout the European Union09/01/2018

Contact address:

Aratana Therapeutics NV
Ambachtenlaan 1
3001 Heverlee
Belgium

Product information

Product information

09/01/2018  Galliprant -EMEA/V/C/004222

Name Language First published Last updated
Galliprant : EPAR - Product Information HR = Hrvatski 2018-02-06  
Galliprant : EPAR - Product Information HR = Hrvatski 2018-02-06  
Galliprant : EPAR - Product Information HR = Hrvatski 2018-02-06  
Galliprant : EPAR - Product Information HR = Hrvatski 2018-02-06  
Galliprant : EPAR - Product Information HR = Hrvatski 2018-02-06  
Galliprant : EPAR - Product Information HR = Hrvatski 2018-02-06  
Galliprant : EPAR - Product Information HR = Hrvatski 2018-02-06  
Galliprant : EPAR - Product Information HR = Hrvatski 2018-02-06  
Galliprant : EPAR - Product Information HR = Hrvatski 2018-02-06  
Galliprant : EPAR - Product Information HR = Hrvatski 2018-02-06  
Galliprant : EPAR - Product Information HR = Hrvatski 2018-02-06  
Galliprant : EPAR - Product Information HR = Hrvatski 2018-02-06  
Galliprant : EPAR - Product Information HR = Hrvatski 2018-02-06  
Galliprant : EPAR - Product Information HR = Hrvatski 2018-02-06  
Galliprant : EPAR - Product Information HR = Hrvatski 2018-02-06  
Galliprant : EPAR - Product Information HR = Hrvatski 2018-02-06  
Galliprant : EPAR - Product Information HR = Hrvatski 2018-02-06  
Galliprant : EPAR - Product Information HR = Hrvatski 2018-02-06  
Galliprant : EPAR - Product Information HR = Hrvatski 2018-02-06  
Galliprant : EPAR - Product Information HR = Hrvatski 2018-02-06  
Galliprant : EPAR - Product Information HR = Hrvatski 2018-02-06  
Galliprant : EPAR - Product Information HR = Hrvatski 2018-02-06  
Galliprant : EPAR - Product Information HR = Hrvatski 2018-02-06  
Galliprant : EPAR - Product Information HR = Hrvatski 2018-02-06  
Galliprant : EPAR - Product Information HR = Hrvatski 2018-02-06  

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
Galliprant : EPAR - All Authorised presentations HR = Hrvatski 2018-02-06  
Galliprant : EPAR - All Authorised presentations HR = Hrvatski 2018-02-06  
Galliprant : EPAR - All Authorised presentations HR = Hrvatski 2018-02-06  
Galliprant : EPAR - All Authorised presentations HR = Hrvatski 2018-02-06  
Galliprant : EPAR - All Authorised presentations HR = Hrvatski 2018-02-06  
Galliprant : EPAR - All Authorised presentations HR = Hrvatski 2018-02-06  
Galliprant : EPAR - All Authorised presentations HR = Hrvatski 2018-02-06  
Galliprant : EPAR - All Authorised presentations HR = Hrvatski 2018-02-06  
Galliprant : EPAR - All Authorised presentations HR = Hrvatski 2018-02-06  
Galliprant : EPAR - All Authorised presentations HR = Hrvatski 2018-02-06  
Galliprant : EPAR - All Authorised presentations HR = Hrvatski 2018-02-06  
Galliprant : EPAR - All Authorised presentations HR = Hrvatski 2018-02-06  
Galliprant : EPAR - All Authorised presentations HR = Hrvatski 2018-02-06  
Galliprant : EPAR - All Authorised presentations HR = Hrvatski 2018-02-06  
Galliprant : EPAR - All Authorised presentations HR = Hrvatski 2018-02-06  
Galliprant : EPAR - All Authorised presentations HR = Hrvatski 2018-02-06  
Galliprant : EPAR - All Authorised presentations HR = Hrvatski 2018-02-06  
Galliprant : EPAR - All Authorised presentations HR = Hrvatski 2018-02-06  
Galliprant : EPAR - All Authorised presentations HR = Hrvatski 2018-02-06  
Galliprant : EPAR - All Authorised presentations HR = Hrvatski 2018-02-06  
Galliprant : EPAR - All Authorised presentations HR = Hrvatski 2018-02-06  
Galliprant : EPAR - All Authorised presentations HR = Hrvatski 2018-02-06  
Galliprant : EPAR - All Authorised presentations HR = Hrvatski 2018-02-06  
Galliprant : EPAR - All Authorised presentations HR = Hrvatski 2018-02-06  
Galliprant : EPAR - All Authorised presentations HR = Hrvatski 2018-02-06  

Pharmacotherapeutic group

Other anti-inflammatory and antirheumatic agents, non-steroids

Therapeutic indication

For the treatment of pain associated with mild to moderate osteoarthritis 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
Galliprant : EPAR - Public assessment report HR = Hrvatski 2018-02-06  
CVMP summary of positive opinion for Galliprant HR = Hrvatski 2017-11-10  

Authorised

This medicine is approved for use in the European Union