Veterinary Medicines

Fleaway Plus 268 mg/241.2 mg Spot-on Solution for Large Dogs

Authorised
  • Fipronil
  • (S)-Methoprene
Download as PDF

Product identification

Medicine name:
Fleaway Plus 268 mg/241.2 mg Spot-on Solution for Large Dogs
Fleaway Plus 268 mg/241.2 mg Spot-on Solution for Large Dogs
Active substance:
  • Fipronil
  • (S)-Methoprene
Target species:
  • Dog
Route of administration:
  • Spot-on use

Product details

Active substance and strength:
  • Fipronil
    268.00
    milligram(s)
    /
    1.00
    Pipette
  • (S)-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:
  • Ireland
Package description:
  • A white pipette composed of a heat-formed shell of polypropylene/cyclic olefin copolymer/polypropylene layer and polyethylene/ethylene vinyl alcohol/polyethylene layer.Box with 1 pipette in an individual foil sachet.
  • A white pipette composed of a heat-formed shell of polypropylene/cyclic olefin copolymer/polypropylene layer and polyethylene/ethylene vinyl alcohol/polyethylene layer.Box with 2 pipettes in individual foil sachets.
  • A white pipette composed of a heat-formed shell of polypropylene/cyclic olefin copolymer/polypropylene layer and polyethylene/ethylene vinyl alcohol/polyethylene layer.Box with 3 pipettes in individual foil sachets.
  • A white pipette composed of a heat-formed shell of polypropylene/cyclic olefin copolymer/polypropylene layer and polyethylene/ethylene vinyl alcohol/polyethylene layer.Box with 4 pipettes in individual foil sachets.

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:
  • Chanelle Pharmaceuticals Manufacturing Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Chanelle Pharmaceuticals Manufacturing Limited
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10987/106/007
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0576/004
Concerned member states:
  • France

Documents

Summary of Product Characteristics

English (PDF)
Published on: 1/06/2025
Download

Combined File of all Documents

English (PDF)
Published on: 1/06/2025
Download

ie-puar-np-600000064253-fleaway-plus-268-mg2412-mg-spot-on-solution-for-la-en.pdf

English (PDF)
Published on: 1/06/2025
Download