Galliprant
Authorised
This medicine is authorised for use in the European Union
grapiprant
MedicineVeterinaryAuthorised
- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
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.
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.
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.
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.
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.
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.
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.
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.
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.
Product information
Latest procedure affecting product information:
IB/0015
13/08/2021
Product details
- Name of medicine
- Galliprant
- Active substance
- grapiprant
- International non-proprietary name (INN) or common name
- grapiprant
- Species
- Dogs
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QM01AX92
Pharmacotherapeutic group
Other antiinflammatory and antirheumatic agents, non-steroidsTherapeutic indication
For the treatment of pain associated with mild to moderate osteoarthritis in dogs.
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