Certifect

Withdrawn

This medicine's authorisation has been withdrawn

fipronil / amitraz / (S)-methoprene

Overview

The marketing authorisation for Certifect has been withdrawn at the request of the marketing-authorisation holder.

Certifect : EPAR - Summary for the public

Reference Number: EMA/532705/2010

Product information

Certifect : EPAR - Product Information

Certifect : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Certifect
• Active substance:
  • fipronil
  • amitraz
  • (S)-methoprene
• International non-proprietary name (INN) or common name:
  fipronil / amitraz / (S)-methoprene
• Species:
  Dogs
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QP53AX65

Pharmacotherapeutic group

Ectoparasiticides for topical use, incl. insecticides

Therapeutic indication

Treatment and prevention of infestations in dogs by ticks (Ixodes ricinus, Dermacentor reticulatus, Rhipicephalus sanguineus, Ixodes scapularis, Dermacentor variabilis, Haemaphysalis elliptica, Haemaphysalis longicornis, Amblyomma americanum and Amblyomma maculatum) and fleas (Ctenocephalides felis and Ctenocephalides canis). Treatment of infestations by chewing lice (Trichodectes canis). Prevention of environmental flea contamination by inhibiting the development of all flea immature stages. The product can be used as part of a treatment strategy for the control of flea-allergy dermatitis. Elimination of fleas and ticks within 24 hours. One treatment prevents further infestations for five weeks by ticks and for up to five weeks by fleas.

The treatment indirectly reduces the risk of transmission of tick-borne diseases (canine babesiosis, monocytic ehrlichiosis, granulocytic anaplasmosis and borreliosis) from infected ticks for four weeks.

Authorisation details

• EMA product number:
  EMEA/V/C/002002
• Marketing authorisation holder:
  Merial

  29 Avenue Tony Garnier; 69007 Lyon; France

• Marketing authorisation issued:
  06/05/2011
• Revision:
  5

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Certifect : EPAR - Public assessment report

Adopted Reference Number: EMA/CVMP/152336/2011

Certifect : EPAR - Scientific Discussion

Reference Number: EMA/532709/2010

CVMP summary of positive opinion for Certifect

Adopted Reference Number: EMA/CVMP/531077/2010