Simparica

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sarolaner

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 04/09/2020

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
1348 Louvain-la-Neuve
Belgium

Product information

12/08/2020 Simparica - EMEA/V/C/003991 - R/0018

Other EU languages available icon 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:

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.

Assessment history

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