Simparica
sarolaner
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Simparica.It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Simparica.
For practical information about using Simparica, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Authorisation details
Product details | |
---|---|
Name |
Simparica
|
Agency product number |
EMEA/V/C/003991
|
Active substance |
sarolaner
|
International non-proprietary name (INN) or common name |
sarolaner
|
Species |
Dogs
|
Anatomical therapeutic chemical veterinary (ATCvet) codes |
QP53BE03
|
Publication details | |
---|---|
Marketing-authorisation holder |
Zoetis Belgium SA
|
Revision |
7
|
Date of issue of marketing authorisation valid throughout the European Union |
06/11/2015
|
Contact address |
Rue Laid Burniat 1 |
Product information
12/08/2020 Simparica - EMEA/V/C/003991 - R/0018
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Ectoparasiticides for systemic use
Therapeutic indication
For the treatment of tick infestations (Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus). The veterinary medicinal product has immediate and persistent tick killing activity for at least 5 weeks.
For the treatment of flea infestations (Ctenocephalides felis and Ctenocephalides canis). The veterinary medicinal product has immediate and persistent flea killing activity against new infestations for at least 5 weeks. The veterinary medicinal product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).
For the treatment of sarcoptic mange (Sarcoptes scabiei).
For the treatment of ear mite infestations (Otodectes cynotis).
For the treatment of demodicosis (Demodex canis).
Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.