Certifect

RSS
Withdrawn

This medicine's authorisation has been withdrawn

fipronil / amitraz / (S)-methoprene
MedicineVeterinaryWithdrawn
  • Application under evaluation
  • CVMP opinion
  • European Commission decision

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The marketing authorisation for Certifect has been withdrawn at the request of the marketing-authorisation holder.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

English (EN) (541.8 KB - PDF)

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български (BG) (650.02 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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español (ES) (542.83 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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čeština (CS) (605.69 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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dansk (DA) (540.5 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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Deutsch (DE) (565.89 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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eesti keel (ET) (543.95 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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ελληνικά (EL) (653.35 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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français (FR) (543.55 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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hrvatski (HR) (565.69 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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italiano (IT) (538.39 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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latviešu valoda (LV) (627.55 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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lietuvių kalba (LT) (589.14 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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magyar (HU) (601.19 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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Malti (MT) (611.4 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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Nederlands (NL) (541.71 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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polski (PL) (601.85 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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português (PT) (564.8 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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română (RO) (586.15 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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slovenčina (SK) (618.25 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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slovenščina (SL) (593.13 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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Suomi (FI) (537.86 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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svenska (SV) (541.92 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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Product information

Certifect : EPAR - Product Information

English (EN) (1.38 MB - PDF)

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български (BG) (1.64 MB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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español (ES) (1.91 MB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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čeština (CS) (1.84 MB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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dansk (DA) (1.32 MB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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Deutsch (DE) (1.94 MB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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eesti keel (ET) (1.42 MB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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ελληνικά (EL) (2.16 MB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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français (FR) (1.32 MB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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hrvatski (HR) (1.45 MB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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íslenska (IS) (1.43 MB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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italiano (IT) (1.42 MB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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latviešu valoda (LV) (1.86 MB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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lietuvių kalba (LT) (1.48 MB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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magyar (HU) (1.86 MB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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Malti (MT) (1.93 MB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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Nederlands (NL) (1.4 MB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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norsk (NO) (1.41 MB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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polski (PL) (1.89 MB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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português (PT) (1.33 MB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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română (RO) (1.47 MB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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slovenčina (SK) (1.88 MB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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slovenščina (SL) (1.82 MB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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Suomi (FI) (1.37 MB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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svenska (SV) (1.32 MB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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Latest procedure affecting product information: R/0011
18/04/2016

Certifect : EPAR - All Authorised presentations

English (EN) (486.04 KB - PDF)

First published: Last updated:
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български (BG) (550.97 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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español (ES) (482.52 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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čeština (CS) (510.77 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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dansk (DA) (486.16 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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Deutsch (DE) (488.52 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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eesti keel (ET) (938.35 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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ελληνικά (EL) (519.06 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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français (FR) (945.51 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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hrvatski (HR) (1.45 MB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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íslenska (IS) (936.37 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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italiano (IT) (935.97 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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latviešu valoda (LV) (510.17 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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lietuvių kalba (LT) (496.21 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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magyar (HU) (978.69 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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Malti (MT) (509.99 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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Nederlands (NL) (484.53 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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norsk (NO) (487.14 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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polski (PL) (499.86 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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português (PT) (485.14 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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română (RO) (495.05 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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slovenčina (SK) (511.2 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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slovenščina (SL) (497.61 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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Suomi (FI) (935.13 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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svenska (SV) (486.82 KB - PDF)

First published: 02/09/2011Last updated: 27/07/2018
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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

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

English (EN) (535.08 KB - PDF)

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Certifect : EPAR - Public assessment report

AdoptedReference Number: EMA/CVMP/152336/2011

English (EN) (774.94 KB - PDF)

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Certifect : EPAR - Scientific Discussion

Reference Number: EMA/532709/2010

English (EN) (728.56 KB - PDF)

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CVMP summary of positive opinion for Certifect

AdoptedReference Number: EMA/CVMP/531077/2010

English (EN) (529.1 KB - PDF)

First published: Last updated:
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