Galliprant

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On 9 November 2017, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion , recommending the granting of a marketing authorisation for the veterinary medicinal product, Galliprant tablets for dogs, intended for the treatment of pain associated with mild to moderate osteoarthritis in dogs. The applicant for this veterinary medicinal product is Aratana Therapeutics NV. The applicant is registered as an SME pursuant to the definition set out in Commission Recommendation 2003/361/EC.

Galliprant is a non-steroidal, anti-inflammatory drug (NSAID), containing grapiprant (ATCvet code QM01AX92) as the active substance. Grapiprant is a non-cyclooxygenase NSAID and acts as a selective antagonist of the EP4 receptor, a key prostaglandin E2 receptor.

The benefit of Galliprant is in the reduction of pain associated with mild to moderate osteoarthritis in dogs. The most common side effects are mild and generally transient gastrointestinal effects (vomiting, soft-formed faeces, diarrhoea, inappetence).

Detailed conditions for the use of this product will be described in the summary of product characteristics (SPC), which will be published in the European public assessment report (EPAR) and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

The CVMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit-risk balance for Galliprant and therefore recommends the granting of the marketing authorisation.

Name Language First published Last updated
CVMP summary of positive opinion for Galliprant (English only) 2017-11-10  

Key facts

Product details for Galliprant
NameGalliprant
INN or common name

grapiprant

Active substance

grapiprant

Date opinion adopted09/11/2017
Company name

Aratana Therapeutics NV

StatusPositive
Application typeInitial authorisation