Mirataz

Opinion

On 10 October 2019, 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 Mirataz, a transdermal ointment, intended for cats. The applicant for this veterinary medicinal product is Aniserve GmbH. The applicant is registered as an SME pursuant to the definition set out in Commission Recommendation 2003/361/EC.

Mirataz is an antidepressant veterinary medicinal product containing mirtazapine (ATCvet code QN06AX11) as active substance, which is a potent antagonist of 5-HT2 and 5-HT3 receptors in the central nervous system (CNS), and a potent inhibitor of histamine H1 receptors. Inhibition of 5-HT2 and histamine H1 receptors may account for the orexigenic effects of the molecule.

The benefit of Mirataz is that it induces weight gain in cats with underlying chronic medical conditions. The most common side effects are application site reactions and behavioural changes.

The full indication is:

for bodyweight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions.

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 Mirataz 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.

Key facts

Name
Mirataz
Agency product number
EMEA/V/C/004733
Species
Cats
Active substance
  • mirtazapine
Date opinion adopted
11/10/2019
Status
Positive
Application type
Initial authorisation

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