Veterinary Medicine Information website

SPOT-ON FIPRONIL 268 MG LARGE DOGS APE

Authorised
  • Fipronil
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Product identification

Medicine name:
SPOT-ON FIPRONIL 268 MG LARGE DOGS APE
Active substance:
  • Fipronil
Target species:
  • Dog
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Fipronil
    268.00
    milligram(s)
    /
    1.00
    Pipette
Pharmaceutical form:
  • Spot-on solution
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AX15
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription except for some pack sizes
Authorisation status:
  • Valid
Authorised in:
  • France
Package description:
  • Cardboard box of 1 pipette of 2.68 mL
  • Cardboard box of 2 pipettes of 2.68 mL
  • Cardboard box of 3 pipettes of 2.68 mL
  • Cardboard box of 6 pipettes of 2.68 mL
  • Cardboard box of 1 aluminium blister of 1 pipette of 2.68 mL
  • Cardboard box of 1 aluminium blister of 2 pipettes of 2.68 mL
  • Cardboard box of 1 aluminium blister of 3 pipettes of 2.68 mL
  • Cardboard box of 1 aluminium blister of 4 pipettes of 2.68 mL
  • Cardboard box of 1 aluminium blister of 6 pipettes of 2.68 mL

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Beaphar
Marketing authorisation date:
Manufacturing sites for batch release:
  • Beaphar B.V.
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/4770855 0/2016
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0322/004
Concerned member states:
  • Croatia
  • Italy
  • Portugal
  • Slovenia
  • Spain

Documents

Combined File of all Documents

English (PDF)
Published on: 11/12/2024
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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
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