Rabitec

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Questions & Answers

On 5 October 2017,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 Rabitec, oral suspension contained in a blister embedded in a bait, intended for active immunisation of foxes and raccoon dogs against rabies to prevent infection and mortality. The applicant for this veterinary medicinal product is IDT Biologika GmbH.

Rabitec is an immunological medicinal product containing live attenuated rabies virus (ATCvet code QI07BD) as active substance.

The benefits of Rabitec are its efficacy in the treatment of foxes and raccoon dogs against rabies to prevent infection and mortality and thus reduce the transmission of rabies virus, usually via the bite of an infected animal, to other animals and humans.

Rabitec is generally well tolerated at the recommended dose; no adverse reactions have been observed.

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

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 Rabitec 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.

 

Name Language First published Last updated
CVMP summary of positive opinion for Rabitec (English only) 2017-10-06  

Key facts

Product details for Rabitec
NameRabitec
INN or common name

live attenuated rabies virus

Active substance

live attenuated rabies virus

Date opinion adopted05/10/2017
Company name

IDT Biologika GmbH

StatusPositive
Application typeInitial authorisation