Cortacare

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On 21 June 2018,the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion*, recommending the granting of a marketing authorisation for the veterinary medicinal product Cortacare, a cutaneous spray solution, intended for symptomatic treatment of inflammatory and pruritic dermatoses in dogs. The applicant for this veterinary medicinal product is Ecuphar.

Cortacare is a corticosteroid dermatological medicinal product containing hydrocortisone aceponate (ATCvet code QD07AC16) 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 benefits of Cortacare are the relief of both inflammation and pruritus leading to a quick improvement of skin lesions observed in case of inflammatory and pruritic dermatoses. 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 will be described in the summary of product characteristics (SPC) which will be published in the European public assessment report (EPAR) 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 Cortacare and therefore recommends the granting of the marketing authorisation.


*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.

Name Language First published Last updated
CVMP summary of positive opinion for Cortacare (English only) 2018-06-22  

Key facts

Product details for Cortacare
NameCortacare
INN or common name

hydrocortisone aceponate

Active substance

hydrocortisone aceponate

Date opinion adopted21/06/2018
Company name

Ecuphar

StatusPositive
Application typeInitial authorisation