Simparica

  • Email
  • Help

Questions & Answers

On 7 September 2017,the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion1, recommending the granting of a variation to the terms of the marketing authorisation for the veterinary medicinal product Simparica. The marketing authorisation holder for this veterinary medicinal product is Zoetis Belgium SA.

Simparica is currently authorised as chewable tablet. The changes concern the addition of new indications for the treatment of ear mites and demodicosis in dogs.

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.


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.

Name Language First published Last updated
CVMP post-authorisation summary of positive opinion for Simparica (English only) 2017-09-08  

Key facts

Product details for Simparica
NameSimparica
INN or common name

sarolaner

Active substance

sarolaner

Date opinion adopted07/09/2017
Company name

Zoetis Belgium SA

StatusPositive
Application typePost authorisation