On 17 June 2021, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion1, recommending the granting of a marketing authorisation for the veterinary medicinal product Tessie oral solution, intended for use in dogs. The applicant for this veterinary medicinal product is Orion Corporation.
Tessie is an anxiolytic medicinal product containing tasipimidine (ATCvet code: QN05CM96) as active substance, which belongs to the class of selective alpha-2A adrenoceptor agonists. It acts by reducing/blocking noradrenaline-mediated neurotransmission in the central nervous system thus leading to dose-dependent sedation, analgesia and sympatholysis.
The benefits of Tessie are its efficacy in alleviating situational anxiety and fear in dogs triggered by noise or owner departure. The most common side effects are lethargy and emesis as well as behavioural disorders (barking, avoidance, disorientation, increased reactivity), pale mucous membranes, ataxia, diarrhoea, urinary incontinence, nausea, gastroenteritis, polydipsia, leucopenia, hypersensitivity reactions, somnolence and anorexia.
The full indication is:
"Short term alleviation of situational anxiety and fear in dogs triggered by noise or owner departure".
Detailed conditions for the use of this product are 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 Tessie and therefore recommends the granting of the marketing authorisation.
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.
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