Trilorale

Opinion

EMA has issued an opinion on this medicine

trilostane

Overview

On 13 March 2024, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion¹, recommending the granting of a marketing authorisation for the veterinary medicinal product Trilorale, oral suspension for dogs. 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.

Trilorale is an anticorticosteroid medicinal product containing Trilostane (QH02CA01) as active substance, an antiadrenal substance which selectively and reversibly inhibits the enzyme system 3 beta hydroxysteroid isomerase, thus blocking the production of cortisol, corticosterone and aldosterone.

The full indication is: For the treatment of pituitary-dependent and adrenal-dependent hyperadrenocorticism (Cushing’s disease and syndrome) in dogs.

The most common side effects with uncommon frequency, i.e. 1 to 10 animals / 1,000 animals treated, are lethargy, vomiting, diarrhoea and anorexia.

Trilorale is a hybrid of Vetoryl, which has been authorised in the Ireland since 1 October 2010. Studies have demonstrated the satisfactory quality of Trilorale, and its bioequivalence to the reference product Vetoryl.

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 Trilorale and therefore recommends the granting of the marketing authorisation.

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¹ 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 Trilorale

AdoptedReference Number: EMA/CVMP/105714/2024

Product details

• Name of medicine:
  Trilorale
• Active substance:
  trilostane
• International non-proprietary name (INN) or common name:
  trilostane
• Species:
  Dogs
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QH02CA01
• EMA product number:
  EMEA/V/C/006124
• Marketing authorisation applicant:
  Axience
• Opinion adopted:
  13/03/2024
• Opinion status:
  Positive