Veterinary Medicines

DUOFLECT SPOT-ON SOLUTION FOR DOGS 10-20 KG

Authorised
  • Fipronil
  • Methoprene
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Product identification

Medicine name:
DUOFLECT SPOT-ON SOLUTION FOR DOGS 10-20 KG
Duoflect voor honden 10-20 kg 85 mg/ml Spot-on oplossing
Duoflect voor honden 10-20 kg 85 mg/ml Solution pour spot-on
Duoflect voor honden 10-20 kg 85 mg/ml Lösung zum Auftropfen
Active substance:
  • Fipronil
  • Methoprene
Target species:
  • Dog
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Fipronil
    239.70
    milligram(s)
    /
    1.00
    Pipette
  • Methoprene
    119.85
    milligram(s)
    /
    1.00
    Pipette
Pharmaceutical form:
  • Spot-on solution
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AX65
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • Pack containing 1 pipette
  • Pack containing 120 pipettes
  • Pack containing 60 pipettes
  • Pack containing 24 pipettes
  • Pack containing 12 pipettes
  • Pack containing 6 pipettes
  • Pack containing 3 pipettes

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Ceva Sante Animale
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
  • Klocke Verwaltungs GmbH
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V469297
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0345/003
Concerned member states:
  • Belgium
  • Croatia
  • Germany
  • Italy
  • Luxembourg
  • Romania
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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Package Leaflet

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Dutch (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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