Cortavance

hydrocortisone

Table of contents

Opinion

On 18 March 2021, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion1, recommending the granting of a variation to the terms of the marketing authorisation for the veterinary medicinal product Cortavance. The marketing authorisation holder for this veterinary medicinal product is Virbac S.A.

Cortavance is currently authorised as cutaneous spray solution for symptomatic treatment of inflammatory and pruritic dermatoses in dogs. The variation concerns the addition of a new therapeutic indication: “for alleviation of clinical signs associated with atopic dermatitis in dogs”.

Detailed conditions for the use of this product are described in the summary of product characteristics (SPC), for which an updated version reflecting the changes will be published in the revised European public assessment report (EPAR) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.


1Applicants 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.

Key facts

Name
Cortavance
Agency product number
EMEA/V/C/000110
International non-proprietary name (INN) or common name
  • hydrocortisone
Species
Dogs
Active substance
  • hydrocortisone aceponate
Date opinion adopted
18/03/2021
Company name
Virbac S.A.
Status
Positive
Application type
Post-authorisation

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