Stemyca

Opinion

EMA has issued an opinion on this medicine

equine umbilical cord-derived mesenchymal stem cells

Overview

On 8 October 2026, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the veterinary medicinal product Stemyca, a concentrate for dispersion for infusion, intended for dogs. The applicant for this veterinary medicinal product is EquiCord S.L.

Stemyca is an intestinal anti-inflammatory veterinary medicinal product containing equine umbilical cord mesenchymal stem cells (EUC-MSCs) (ATCvet code not yet available) as the active substance, which are thought to act via prostaglandin secretion, as well as their immunomodulatory and anti-inflammatory properties. These properties have been demonstrated in proprietary in vitro studies.

The benefit of Stemyca is its efficacy in the indication ‘reduction of clinical signs of non-food-responsive chronic inflammatory enteropathy (CIE) in dogs’. Stemyca will thus provide a new treatment possibility for the reduction of clinical signs for this disease in dogs.

There were no adverse events detected in dogs. Stemyca is generally well tolerated at the recommended dose. No adverse reactions were observed in an exploratory study with a double dose conducted in dogs. 

The full indication is: “Reduction of clinical signs of non-food-responsive chronic inflammatory enteropathy (CIE) in dogs”.

Detailed conditions for the use of this product are described in the summary of product characteristics (SPC), which will be published in the Union Product Database (UPD) 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 Stemyca and therefore recommends the granting of the marketing authorisation.

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Notes: Applicants may appeal any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to appeal within 15 days of receipt of the opinion.

CVMP summary of positive opinion for Stemyca

Adopted Reference Number: EMA/CVMP/192960/2026

Product details

• Name of medicine:
  Stemyca
• International non-proprietary name (INN) or common name:
  equine umbilical cord-derived mesenchymal stem cells
• Species:
  Dogs
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QA07E
• EMA product number:
  EMEA/V/C/006713
• Marketing authorisation applicant:
  Equicord S.L.
• Opinion adopted:
  08/10/2026
• Opinion status:
  Positive