Veterinary Medicine Information website

FIPROTEC COMBO 268 MG/241,2 MG SPOT-ON SOLUTION FOR LARGE DOGS

Authorised
  • Fipronil
  • Methoprene
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Product identification

Medicine name:
FIPROTEC COMBO 268 MG/241,2 MG SPOT-ON SOLUTION FOR LARGE DOGS
Active substance:
  • Fipronil
  • Methoprene
Target species:
  • Dog
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Fipronil
    268.00
    milligram(s)
    /
    1.00
    Pipette
  • Methoprene
    241.20
    milligram(s)
    /
    1.00
    Pipette
Pharmaceutical form:
  • Spot-on solution
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AX65
Legal status of supply:
  • Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Available in:
  • France
Package description:
  • Cardbox containing 1 single-dose pipette (2.68ml)
  • Cardbox containing 30 single-dose pipettes (2.68ml)
  • Cardbox containing 10 single-dose pipettes (2.68ml)
  • Cardbox containing 6 single-dose pipettes (2.68ml)
  • Cardbox containing 3 single-dose pipettes (2.68ml)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
  • KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/2023320 8/2016
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0334/004
Concerned member states:
  • Czechia
  • Italy
  • Netherlands
  • Slovakia
  • Spain
  • 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.
French (PDF)
Published on: 30/01/2025
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Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 15/10/2025
Download