Veterinary Medicines

Fiprex Duo L 268 mg + 241.2 mg spot-on solution for dogs

Authorised
  • (S)-Methoprene
  • Fipronil
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Product identification

Medicine name:
Fiprex Duo L 268 mg + 241.2 mg spot-on solution for dogs
Fiprex Duo L 268 mg / 2,68 ml + 241,20 mg / 2,68 ml Roztwór do nakrapiania
Active substance:
  • (S)-Methoprene
  • Fipronil
Target species:
  • Dog
Route of administration:
  • Spot-on use

Product details

Active substance and strength:
  • (S)-Methoprene
    241.20
    milligram(s)
    /
    1.00
    Pipette
  • Fipronil
    268.00
    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:
  • Poland
Package description:
  • A red pipette composed of a heat-formed shell ( internal layer PE/EVOH/PE external layer PP/COC/PP) and a film(PET/PE/ALU/PE).Package sizes:1 x 2.68 ml pipette in carton box

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:
  • Przedsiebiorstwo Wielobranzowe Vet-Agro Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Przedsiebiorstwo Wielobranzowe Vet-Agro Sp. z o.o.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2966
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0450/003
Concerned member states:
  • Bulgaria
  • Greece
  • Hungary
  • Italy
  • Lithuania
  • Poland
  • Portugal
  • Romania
  • Spain

Documents

Summary of Product Characteristics

English (PDF)
Published on: 8/06/2025
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Polish (PDF)
Published on: 20/11/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 21/08/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 21/08/2025
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Combined File of all Documents

English (PDF)
Published on: 8/06/2025
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ie-puar-mr-iev0450003-fiprex-duo-l-268-mg--2412-mg-spot-on-solution-for--en.pdf

English (PDF)
Published on: 8/06/2025
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