Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: CERTIFECT   
Auth. number : EU/2/11/125
INN : (S)-Methoprene, Fipronil, Amitraz
ATC: Anatomical main group: QP - Antiparasitic products, insecticides and repellents
Therapeutic subgroup: QP53 - Ectoparaciticides, insecticides and repellents
Pharmacological subgroup: QP53A - Ectoparasiticides for topical use, incl. insecticides
Chemical subgroup: QP53AX - Other ectoparasiticides for topical use
Chemical substance: QP53AX65 - Fipronil, combinations
(See WHO ATCvet Index)
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 (FAD). Elimination of fleas and ticks within 24 hours. One treatment prevents further infestations for 5 weeks by ticks and for up to 5 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 4 weeks.
Marketing Authorisation Holder: Merial
29 avenue Tony Garnier, F-69007 Lyon, France

  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
12/05/2011 Centralised - Authorisation EMEA/V/C/2002 (2011)3242 of 06/05/2011
09/11/2012 Centralised - Variation EMEA/V/C/2002/IB/3
Updated with Decision(2013)8337 of 20/11/2013
26/02/2013 Corrigendum (2011)3242 of 06/05/2011
12/09/2013 Centralised - Variation EMEA/V/C/2002/II/6
Updated with Decision(2013)8337 of 20/11/2013
22/11/2013 Centralised - Variation (2013)8337 of 20/11/2013
14/03/2014 Centralised - Variation EMEA/V/C/2002/IA/7
26/03/2014 Centralised - Variation EMEA/V/C/2002/IB/8