Emepax

Opinion

EMA has issued an opinion on this medicine

maropitant

Overview

On 12 February 2026, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the veterinary medicinal product Emepax, Chewable tablet, intended for Dog. The applicant for this veterinary medicinal product is Axience. The applicant is registered as an SME pursuant to the definition set out in Commission Recommendation 2003/361/EC.

Emepax is an anti-emetic medicinal product containing Maropitant (ATCvet code QA04 AD90) as active substance. Maropitant is a neurokinin-1 (NK1) receptor antagonist, which acts in the central nervous system by inhibiting Substance P, the key neurotransmitter involved in vomiting.

The benefits of Emepax are

• Prevention of nausea induced by chemotherapy in dogs.
• Prevention of vomiting induced by motion sickness in dogs.
• Prevention and treatment of vomiting, in conjunction with maropitant solution for injection and in combination with other supportive measures in dogs.

The most common side effects are vomiting and in very rare cases lethargy and neurological disorders.

Emepax is a generic of Cerenia, which has been authorised in the EU since 29 September 2006. Studies have demonstrated the satisfactory quality of Emepax, and its bioequivalence to the reference product Cerenia.

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 Emepax and therefore recommends the granting of the marketing authorisation.

---

Note: 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 Emepax

Reference Number: EMA/CVMP/25902/2026

Product details

• Name of medicine:
  Emepax
• Active substance:
  maropitant
• International non-proprietary name (INN) or common name:
  maropitant
• Species:
  Dogs
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QA04AD90
• EMA product number:
  EMEA/V/C/006655
• Marketing authorisation applicant:
  Axience
• Opinion adopted:
  12/02/2026
• Opinion status:
  Positive