Comfortis

Withdrawn

This medicine's authorisation has been withdrawn

spinosad

Overview

The marketing authorisation for Comfortis has been withdrawn at the request of the marketing authorisation holder

Comfortis : EPAR - Summary for the public

Product information

Comfortis : EPAR - Product Information

Comfortis : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Comfortis
• Active substance:
  spinosad
• International non-proprietary name (INN) or common name:
  spinosad
• Species:
  • Dogs
  • Cats
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QP53BX03

Pharmacotherapeutic group

Other ectoparasiticides for systemic use

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).

Authorisation details

• EMA product number:
  EMEA/V/C/002233
• Marketing authorisation holder:
  Elanco GmbH

  Heinz-Lohmann-Str. 4; 27472 Cuxhaven; Germany

• Opinion adopted:
  08/12/2010
• Marketing authorisation issued:
  11/02/2011
• Revision:
  12

Assessment history

Changes since initial authorisation of medicine

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

Comfortis-V-C-2233-X-10 : EPAR - Assessment Report - Extension

Adopted Reference Number: EMA/CVMP/615967/2013

CVMP post-authorisation summary of positive opinion for Comfortis

Adopted Reference Number: EMA/CVMP/490575/2013

Comfortis-V-C-2233-X-06-G : EPAR - Assessment Report - Extension

Adopted Reference Number: EMA/CVMP/700676/2012

CVMP post-authorisation summary of positive opinion for Comfortis

Adopted Reference Number: EMA/CVMP/676652/2012

Initial marketing authorisation documents

Comfortis : EPAR - Scientific Discussion

Reference Number: EMA/CVMP/63440/2010

CVMP summary of positive opinion for Comfortis

Adopted Reference Number: EMA/CVMP/499406/2010