Jaguar Health Seeks EMA Feedback on Canalevia EU Approval for Dog Diarrhea

Reuters12-02

Jaguar Health Seeks EMA Feedback on Canalevia EU Approval for Dog Diarrhea

Jaguar Health Inc. announced that its Italian subsidiary, Napo Therapeutics S.p.A., has submitted a request to the European Medicines Agency $(EMA)$ for scientific advice regarding the approval pathway for Canalevia (crofelemer delayed-release tablets) for the treatment of general diarrhea in dogs in the European Union. The request asks the EMA's Committee for Veterinary Medicinal Products (CVMP) to review the company's plan and data from a completed study during a scheduled meeting in March 2026. If the EMA agrees that the updated analysis supports approval, Jaguar Health will submit a Marketing Authorization Application for Canalevia, which, if approved, would allow the product to be marketed for general diarrhea in dogs across all 27 EU member countries.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Jaguar Health Inc. published the original content used to generate this news brief via ACCESS Newswire (Ref. ID: 1113655) on December 02, 2025, and is solely responsible for the information contained therein.

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