Comfortis
spinosad
Table of contents
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).
Authorisation details
Product details | |
---|---|
Name |
Comfortis
|
Agency product number |
EMEA/V/C/002233
|
Active substance |
spinosad
|
International non-proprietary name (INN) or common name |
spinosad
|
Species |
|
Anatomical therapeutic chemical veterinary (ATCvet) codes |
QP53BX03
|
Publication details | |
---|---|
Marketing-authorisation holder |
Elanco GmbH
|
Revision |
12
|
Date of issue of marketing authorisation valid throughout the European Union |
11/02/2011
|
Contact address |
Heinz-Lohmann-Str. 4 |
Product information
10/09/2021 Comfortis - EMEA/V/C/002233 - IB/0025/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Therapeutic 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).