On 23 January 2020, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion*, recommending the granting of a variation to the terms of the marketing authorisation for the veterinary medicinal product Rabitec. The marketing authorisation holder for this veterinary medicinal product is IDT Biologika GmbH.
Rabitec is currently authorised as an oral suspension for the active immunization of foxes and raccoon dogs against rabies to prevent infection and mortality. The variation concerns extending the duration of immunity of the product from 6 to 12 months.
Detailed conditions for the use of this product are described in the updated 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.
*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.
|Agency product number||
|International non-proprietary name (INN) or common name||
Red foxes (Vulpes vulpes)
Raccoon dogs (Nyctereutes procyonoides)
|Date opinion adopted||
Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 3-5 November 202006/11/2020