Pharmaceuticals - Community Register


Community register of veterinary medicinal products


Product information

Invented name: Comfortis   
Auth. number : EU/2/10/115
Active substance : Spinosad
ATC: Anatomical main group: QP - Antiparasitic products, insecticides and repellents
Therapeutic subgroup: QP53 - Ectoparaciticides, insecticides and repellents
Pharmacological subgroup: QP53B - Ectoparasiticides for systemic use
Chemical subgroup: QP53BX - Other ectoparasiticides for systemic use
Chemical substance: QP53BX03 - spinosad
(See WHO ATCvet Index)
Indication: Treatment and prevention of flea infestations (Ctenocephalides felis).
The 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 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
15/02/2011 Centralised - Authorisation EMEA/V/C/2233 (2011)976 of 11/02/2011
4/05/2011 Centralised - Variation (no change in Commission Decision) EMEA/V/C/2233/IA/1/G
7/11/2012 Centralised - Variation EMEA/V/C/2233/IB/8/G
Updated with Decision(2013)214 of 14/01/2013
17/01/2013 Centralised - Variation EMEA/V/C/2233/X/6/G (2013)214 of 14/01/2013
15/11/2013 Centralised - Variation EMEA/V/C/2233/X/10 (2013)8068 of 13/11/2013
20/12/2013 Centralised - Variation EMEA/V/C/2233/IA/G/386
Updated with Decision(2014)9823 of 11/12/2014
5/12/2014 Centralised - Variation EMEA/V/C/2233/IB/14
Updated with Decision(2016)77 of 07/01/2016
15/12/2014 Centralised - Yearly update (2014)9823 of 11/12/2014
11/01/2016 Centralised - Renewal EMEA/V/C/2233/R/15 (2016)77 of 7/01/2016