Stronghold

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selamectin

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

Overview

This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 15/01/2019

Authorisation details

Product details
Name
Stronghold
Agency product number
EMEA/V/C/000050
Active substance
selamectin
International non-proprietary name (INN) or common name
selamectin
Species
  • Dogs
  • Cats
Anatomical therapeutic chemical veterinary (ATCvet) codes
QP54AA05
Publication details
Marketing-authorisation holder
Zoetis Belgium SA
Revision
23
Date of issue of marketing authorisation valid throughout the European Union
25/11/1999
Contact address

Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium

Product information

14/12/2018 Stronghold - EMEA/V/C/000050 - IAIN-0058

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.

Pharmacotherapeutic group

  • ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS
  • ENDECTOCIDES
  • Macrocyclic lactones

Therapeutic indication

Cats and dogs:

  • Treatment and prevention of flea infestations caused by Ctenocephalides spp. for one month following a single administration. This is as a result of the adulticidal, larvicidal and ovicidal properties of the product. The product is ovicidal for 3 weeks after administration. Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will also aid in the prevention of flea infestations in the litter up to seven weeks of age. The product can be used as part of a treatment strategy for flea allergy dermatitis and through its ovicidal and larvicidal action may aid in the control of existing environmental flea infestations in areas to which the animal has access.
  • Prevention of heartworm disease caused by Dirofilaria immitis with monthly administration. Stronghold may be safely administered to animals infected with adult heartworms, however, it is recommended, in accordance with good veterinary practice, that all animals 6 months of age or more living in countries where a vector exists should be tested for existing adult heartworm infections before beginning medication with Stronghold. It is also recommended that dogs should be tested periodically for adult heartworm infections, as an integral part of a heartworm prevention strategy, even when Stronghold has been administered monthly. This product is not effective against adult D. immitis.
  • Treatment of ear mites (Otodectes cynotis).

Cats:

  • Treatment of biting lice infestations (Felicola subrostratus
  • Treatment of adult roundworms (Toxocara cati)
  • Treatment of adult intestinal hookworms (Ancylostoma tubaeforme).

Dogs:

  • Treatment of biting lice infestations (Trichodectes canis)
  • Treatment of sarcoptic mange (caused by Sarcoptes scabiei)
  • Treatment of adult intestinal roundworms (Toxocara canis).

Assessment history

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