Alcort

Opinion

EMA has issued an opinion on this medicine

hydrocortisone aceponate

Overview

On 13-14 February 2024, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion¹, recommending the granting of a marketing authorisation for the veterinary medicinal product Alcort, Cutaneous spray, solution, intended for dogs. The applicant for this veterinary medicinal product is Nextmune Italy S.r.l.. 

Alcort is a dermatological medicinal product containing hydrocortisone aceponate (ATCvet code QD07AC) as active substance, with a potent intrinsic glucocorticoid activity. It accumulates in the dog’s skin allowing high local activity with reduced systemic secondary effects.
The full indication is: for symptomatic treatment of inflammatory and pruritic dermatoses in dogs.

For alleviation of clinical signs associated with atopic dermatitis. 

The most common side effects are transient local reactions at the application site (erythema and/or pruritus) which can occur in very rare cases.

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 Alcort and therefore recommends the granting of the marketing authorisation.

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¹Summaries of opinion are published without prejudice to the Commission Decision.

CVMP summary of positive opinion for Alcort

Reference Number: EMA/CVMP/44401/2024

Product details

• Name of medicine:
  Alcort
• Active substance:
  hydrocortisone aceponate
• International non-proprietary name (INN) or common name:
  hydrocortisone aceponate
• Species:
  Dogs
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QD07AC16
• EMA product number:
  EMEA/V/C/006143
• Marketing authorisation applicant:
  Nextmune Italy S.r.l.
• Opinion adopted:
  14/02/2024
• Opinion status:
  Positive