Trifexis

Expired

This medicine's authorisation has expired

spinosad / milbemycin oxime

Overview

The marketing authorisation for Trifexis has expired following the marketing-authorisation holder’s decision not to apply for a renewal.

Trifexis : EPAR - Summary for the public

Reference Number: EMA/437444/2013

Product information

Trifexis : EPAR - Product Information

Trifexis : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Trifexis
• Active substance:
  • spinosad
  • milbemycin oxime
• International non-proprietary name (INN) or common name:
  • spinosad
  • milbemycin oxime
• Species:
  Dogs
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QP54AB51

Pharmacotherapeutic group

• Antiparasitic products, insecticides and repellents
• Endectocides

Therapeutic indication

For the treatment and prevention of flea (Ctenocephalides felis) infestations in dogs where one or more of the following indications are required concurrently:

 

• prevention of heartworm disease (L3, L4 Dirofilaria immitis);
• prevention of angiostrongylosis by reducing the level of infection with immature adult (L5) Angiostrongylus vasorum;
• treatment of gastrointestinal nematode infections caused by hookworm (L4, immature adult, L5) and adult Ancylostoma caninum), roundworms (immature adult L5, and adult Toxocara canis and adult Toxascaris leonina) and whipworm (adult Trichuris vulpis).

 

Authorisation details

• EMA product number:
  EMEA/V/C/002635
• Marketing authorisation holder:
  Eli Lilly and Company Limited

  Elanco Animal Health; Priestly Road; Basingstoke; Hampshire RG24 9NL; United Kingdom

• Opinion adopted:
  18/07/2013
• Marketing authorisation issued:
  19/09/2013
• Expiry of marketing authorisation:
  23/09/2018
• Revision:
  4

Assessment history

Changes since initial authorisation of medicine

Trifexis : EPAR - Procedural steps taken and scientific information after authorisation

Trifexis-V-C-2635-II-0008 : EPAR - Assessment Report

Adopted Reference Number: EMA/859733/2016

CVMP post-authorisation summary of positive opinion for Trifexis (II-0008)

Adopted Reference Number: EMA/CVMP/713330/2016

Initial marketing authorisation documents

CVMP summary of positive opinion for Trifexis

Adopted Reference Number: EMA/CVMP/374777/2013