Aservo EquiHaler

ciclesonide

Opinion

On 7 November 2019, 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 Aservo EquiHaler, inhalation solution, intended for horses. The applicant for this veterinary medicinal product is Boehringer Ingelheim Vetmedica GmbH.

Aservo EquiHaler is a glucocorticoid medicinal product containing ciclesonide (ATCvet code QR03BA08) as active substance, and is a pro-drug, which following inhalation is converted into the active metabolite, desisobutyryl-ciclesonide (des-CIC) in the airways. Des-ciclesonide has anti-inflammatory properties which are exerted through a wide range of inhibitory activities.

The benefits of Aservo EquiHaler are its efficacy in the alleviation of clinical signs associated with chronic severe equine asthma. The most common side effects are mild nasal discharge.

The appropriate CVMP guidelines on data requirements for veterinary medicinal products intended for minor use or minor species/limited markets have been applied in the assessment of the application.

The full indication is: for the alleviation of clinical signs of severe equine asthma (formerly known as Recurrent Airway Obstruction (RAO), Summer Pasture Associated Recurrent Airway Obstruction (SPA-RAO)).

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 Aservo EquiHaler and therefore recommends the granting of the marketing authorisation.


1 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
Aservo EquiHaler
Agency product number
EMEA/V/C/004991
International non-proprietary name (INN) or common name
  • ciclesonide
Species
Horses
Active substance
  • ciclesonide
Date opinion adopted
07/11/2019
Company name
Boehringer Ingelheim Vetmedica GmbH
Status
Positive
Application type
Initial authorisation

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