Pharmaceuticals - Community Register


Community register of veterinary medicinal products


Product information

Invented name: Trifexis   
Auth. number : EU/2/13/155
Active substance : Spinosad / Milbemycin oxime
ATC: Anatomical main group: QP - Antiparasitic products, insecticides and repellents
Therapeutic subgroup: QP54 - Endectocides
Pharmacological subgroup: QP54A - Macrocyclic lactones
Chemical subgroup: QP54AB - Milbemycins
Chemical substance: QP54AB51 - milbemycin, combinations
(See WHO ATCvet Index)
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).
The flea preventive effect against re-infestations is a result of the adulticidal activity and the reduction
in egg production and persists for up to 4 weeks after a single administration of the veterinary
medicinal product.
The veterinary medicinal product can be used as part of a treatment strategy for the control of flea
allergy dermatitis (FAD).
Marketing Authorisation Holder: Eli Lilly and Company Ltd, Elanco Animal Health
Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
23/09/2013 Centralised - Authorisation EMEA/V/C/2635 (2013)6217 of 19/09/2013
20/12/2013 Centralised - Variation EMEA/V/C/2635/IG/386/2
Updated with Decision(2014)9828 of 11/12/2014
15/12/2014 Centralised - Yearly update (2014)9828 of 11/12/2014
13/02/2015 Centralised - Notification EMEA/V/C/2635/IB/6
Updated with Decision(2016)1330 of 26/02/2016
01/03/2016 Centralised - Yearly update (2016)1330 of 26/02/2016
21/02/2017 Centralised - 2-Monthly update EMEA/V/C/2635/II/8 (2017)1292 of 17/02/2017