Simparica

sarolaner

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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.

What is Simparica and what is it used for?

Simparica is a veterinary medicine used to treat tick, flea and sarcoptic mange infestations in dogs. After Simparica is given its activity against ticks and fleas lasts for for at least 5 weeks. Simparica can be used as part of the management of flea allergy dermatitis (an allergic reaction to flea bites). It contains the active substance sarolaner.

For further information, see the package leaflet.

How is Simparica used?

Simparica is available as chewable tablets (5, 10, 20, 40, 80 and 120 mg) and can only be obtained with a prescription. The appropriate strength tablet(s) should be used according to the dog’s weight.

For treatment of tick and flea infestations Simparica should be given once every month throughout the flea and/or tick season for optimal control.

For treatment of sarcoptic mange, Simparica is given monthly for two consecutive months.

For further information, see the package leaflet.

How does Simparica work?

The active substance in Simparica, sarolaner acts as an ‘ectoparasiticide’. This means that it kills parasites that live on the skin or in the fur of animals, such as fleas, ticks and mites. In order to be exposed to the active substance, fleas and ticks must attach to the skin and commence feeding on the dog’s blood. Sarolaner kills these parasites that have ingested the dog’s blood by acting on their nervous system. It blocks the normal movement of charged chloride particles (ions) in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA) and glutamate, two substances that convey messages between nerves (neurotransmitters). This results in uncontrolled activity of the nervous system and the paralysis and death of the parasites. Sarolaner kills fleas before they can lay eggs and so helps to reduce contamination of the dog’s environment.

What benefits of Simparica have been shown in studies?

The effectiveness of Simparica against fleas was investigated in a field study in dogs infested with at least five live fleas. 189 dogs were treated with Simparica for three months whilst 96 dogs were given another medicine, spinosad. Simparica was as effective as spinosad in reducing flea counts for up to 90 days after treatment.

A second field study was conducted in dogs infested with at least three live attached ticks. 122 dogs were treated with Simparica for three months whilst 59 dogs were treated with another medicine, fipronil, against ticks. Simparica was as effective as fipronil in reducing tick counts for up to 90 days after treatment.

A third study involved dogs infested with sarcoptic mange. 53 dogs were treated with Simparica for two months whilst 26 dogs were given a medicine containing moxidectin and imidacloprid. Simparica was as effective as moxidectin and imidacloprid in eliminating live mites in skin scrapings.

What are the risks associated with Simparica?

Because fleas and ticks must start feeding on the dog in order to be killed by the medicine, the risk of transmission of diseases with which they may be infected cannot be excluded.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

Safety information has been included in the summary of product characteristics and the package leaflet for Simparica, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.

The tablets should be kept in the original package until use in order to prevent children directly accessing the medicine.

Hands should be washed after handling the medicine. If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately.

Why is Simparica approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Simparica’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Other information about Simparica

The European Commission granted a marketing authorisation valid throughout the EU for Simparica on 6 November 2015.

For more information about treatment with Simparica, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

Name Language First published Last updated
Simparica : EPAR - Summary for the public BG = bălgarski 2015-12-18  
Simparica : EPAR - Summary for the public ES = español 2015-12-18  
Simparica : EPAR - Summary for the public CS = čeština 2015-12-18  
Simparica : EPAR - Summary for the public DA = dansk 2015-12-18  
Simparica : EPAR - Summary for the public DE = Deutsch 2015-12-18  
Simparica : EPAR - Summary for the public ET = eesti keel 2015-12-18  
Simparica : EPAR - Summary for the public EL = elliniká 2015-12-18  
Simparica : EPAR - Summary for the public EN = English 2015-12-18  
Simparica : EPAR - Summary for the public FR = français 2015-12-18  
Simparica : EPAR - Summary for the public IT = italiano 2015-12-18  
Simparica : EPAR - Summary for the public LV = latviešu valoda 2015-12-18  
Simparica : EPAR - Summary for the public LT = lietuvių kalba 2015-12-18  
Simparica : EPAR - Summary for the public HU = magyar 2015-12-18  
Simparica : EPAR - Summary for the public MT = Malti 2015-12-18  
Simparica : EPAR - Summary for the public NL = Nederlands 2015-12-18  
Simparica : EPAR - Summary for the public PL = polski 2015-12-18  
Simparica : EPAR - Summary for the public PT = português 2015-12-18  
Simparica : EPAR - Summary for the public RO = română 2015-12-18  
Simparica : EPAR - Summary for the public SK = slovenčina 2015-12-18  
Simparica : EPAR - Summary for the public SL = slovenščina 2015-12-18  
Simparica : EPAR - Summary for the public FI = suomi 2015-12-18  
Simparica : EPAR - Summary for the public SV = svenska 2015-12-18  
Simparica : EPAR - Summary for the public HR = Hrvatski 2015-12-18  

This EPAR was last updated on 10/04/2017 .

Authorisation details

Product details

Product details for Simparica
NameSimparica
Agency product numberEMEA/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

Publication details for Simparica
Marketing-authorisation holder

Zoetis Belgium SA

Revision3
Date of issue of marketing authorisation valid throughout the European Union06/11/2015

Contact address:

Zoetis Belgium SA
Rue Laid Burniat, 1
1348 Louvain-la-Neuve
Belgium

Product information

Product information

23/03/2017  Simparica -EMEA/V/C/003991 -IG/0747

Name Language First published Last updated
Simparica : EPAR - Product Information HR = Hrvatski 2015-12-18 2017-04-10
Simparica : EPAR - Product Information HR = Hrvatski 2015-12-18 2017-04-10
Simparica : EPAR - Product Information HR = Hrvatski 2015-12-18 2017-04-10
Simparica : EPAR - Product Information HR = Hrvatski 2015-12-18 2017-04-10
Simparica : EPAR - Product Information HR = Hrvatski 2015-12-18 2017-04-10
Simparica : EPAR - Product Information HR = Hrvatski 2015-12-18 2017-04-10
Simparica : EPAR - Product Information HR = Hrvatski 2015-12-18 2017-04-10
Simparica : EPAR - Product Information HR = Hrvatski 2015-12-18 2017-04-10
Simparica : EPAR - Product Information HR = Hrvatski 2015-12-18 2017-04-10
Simparica : EPAR - Product Information HR = Hrvatski 2015-12-18 2017-04-10
Simparica : EPAR - Product Information HR = Hrvatski 2015-12-18 2017-04-10
Simparica : EPAR - Product Information HR = Hrvatski 2015-12-18 2017-04-10
Simparica : EPAR - Product Information HR = Hrvatski 2015-12-18 2017-04-10
Simparica : EPAR - Product Information HR = Hrvatski 2015-12-18 2017-04-10
Simparica : EPAR - Product Information HR = Hrvatski 2015-12-18 2017-04-10
Simparica : EPAR - Product Information HR = Hrvatski 2015-12-18 2017-04-10
Simparica : EPAR - Product Information HR = Hrvatski 2015-12-18 2017-04-10
Simparica : EPAR - Product Information HR = Hrvatski 2015-12-18 2017-04-10
Simparica : EPAR - Product Information HR = Hrvatski 2015-12-18 2017-04-10
Simparica : EPAR - Product Information HR = Hrvatski 2015-12-18 2017-04-10
Simparica : EPAR - Product Information HR = Hrvatski 2015-12-18 2017-04-10
Simparica : EPAR - Product Information HR = Hrvatski 2015-12-18 2017-04-10
Simparica : EPAR - Product Information HR = Hrvatski 2015-12-18 2017-04-10
Simparica : EPAR - Product Information HR = Hrvatski 2015-12-18 2017-04-10
Simparica : EPAR - Product Information HR = Hrvatski 2015-12-18 2017-04-10

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Simparica : EPAR - All Authorised presentations HR = Hrvatski 2015-12-18  
Simparica : EPAR - All Authorised presentations HR = Hrvatski 2015-12-18  
Simparica : EPAR - All Authorised presentations HR = Hrvatski 2015-12-18  
Simparica : EPAR - All Authorised presentations HR = Hrvatski 2015-12-18  
Simparica : EPAR - All Authorised presentations HR = Hrvatski 2015-12-18  
Simparica : EPAR - All Authorised presentations HR = Hrvatski 2015-12-18  
Simparica : EPAR - All Authorised presentations HR = Hrvatski 2015-12-18  
Simparica : EPAR - All Authorised presentations HR = Hrvatski 2015-12-18  
Simparica : EPAR - All Authorised presentations HR = Hrvatski 2015-12-18  
Simparica : EPAR - All Authorised presentations HR = Hrvatski 2015-12-18  
Simparica : EPAR - All Authorised presentations HR = Hrvatski 2015-12-18  
Simparica : EPAR - All Authorised presentations HR = Hrvatski 2015-12-18  
Simparica : EPAR - All Authorised presentations HR = Hrvatski 2015-12-18  
Simparica : EPAR - All Authorised presentations HR = Hrvatski 2015-12-18  
Simparica : EPAR - All Authorised presentations HR = Hrvatski 2015-12-18  
Simparica : EPAR - All Authorised presentations HR = Hrvatski 2015-12-18  
Simparica : EPAR - All Authorised presentations HR = Hrvatski 2015-12-18  
Simparica : EPAR - All Authorised presentations HR = Hrvatski 2015-12-18  
Simparica : EPAR - All Authorised presentations HR = Hrvatski 2015-12-18  
Simparica : EPAR - All Authorised presentations HR = Hrvatski 2015-12-18  
Simparica : EPAR - All Authorised presentations HR = Hrvatski 2015-12-18  
Simparica : EPAR - All Authorised presentations HR = Hrvatski 2015-12-18  
Simparica : EPAR - All Authorised presentations HR = Hrvatski 2015-12-18  
Simparica : EPAR - All Authorised presentations HR = Hrvatski 2015-12-18  
Simparica : EPAR - All Authorised presentations HR = Hrvatski 2015-12-18  

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).

Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Simparica : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2016-01-26 2017-04-10

Initial marketing-authorisation documents

Name Language First published Last updated
Simparica : EPAR - Public assessment report HR = Hrvatski 2015-12-18  
CVMP summary of positive opinion for Simparica HR = Hrvatski 2015-09-11 2015-09-15