Veterinary Medicine Information website

Fleanil Duo 67 mg / 60.3 mg Spot-on Solution for Small Dogs

Authorised
  • Fipronil
  • (S)-Methoprene
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Product identification

Medicine name:
Fleanil Duo 67 mg / 60.3 mg Spot-on Solution for Small Dogs
Active substance:
  • Fipronil
  • (S)-Methoprene
Target species:
  • Dog
Route of administration:
  • Spot-on use

Product details

Active substance and strength:
  • Fipronil
    67.00
    milligram(s)
    /
    1.00
    Pipette
  • (S)-Methoprene
    60.30
    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:
  • United Kingdom (Northern Ireland)
Package description:
  • 0.67 ml pipette, moulded from a film composed of 3 layers: a polypropylene/COC/polypropylene, solvent free lacquer laminateand a copolymer of polyethylene/EVOH/polyethylene. The pipettes are sealed within a child resistant 4-ply foil sachetcomposed of LDPE/nylon/aluminium foil/polyester film and presented in an outer box.Pipettes are presented in boxes containing 6 pipettes. Each pipette is individually sealed in a foil sachet.
  • 0.67 ml pipette, moulded from a film composed of 3 layers: a polypropylene/COC/polypropylene, solvent free lacquer laminateand a copolymer of polyethylene/EVOH/polyethylene. The pipettes are sealed within a child resistant 4-ply foil sachetcomposed of LDPE/nylon/aluminium foil/polyester film and presented in an outer box.Pipettes are presented in boxes containing 4 pipettes. Each pipette is individually sealed in a foil sachet.
  • 0.67 ml pipette, moulded from a film composed of 3 layers: a polypropylene/COC/polypropylene, solvent free lacquer laminateand a copolymer of polyethylene/EVOH/polyethylene. The pipettes are sealed within a child resistant 4-ply foil sachetcomposed of LDPE/nylon/aluminium foil/polyester film and presented in an outer box.Pipettes are presented in boxes containing 3 pipettes. Each pipette is individually sealed in a foil sachet.
  • 0.67 ml pipette, moulded from a film composed of 3 layers: a polypropylene/COC/polypropylene, solvent free lacquer laminateand a copolymer of polyethylene/EVOH/polyethylene. The pipettes are sealed within a child resistant 4-ply foil sachetcomposed of LDPE/nylon/aluminium foil/polyester film and presented in an outer box.Pipettes are presented in boxes containing 2 pipettes. Each pipette is individually sealed in a foil sachet.
  • 0.67 ml pipette, moulded from a film composed of 3 layers: a polypropylene/COC/polypropylene, solvent free lacquer laminateand a copolymer of polyethylene/EVOH/polyethylene. The pipettes are sealed within a child resistant 4-ply foil sachetcomposed of LDPE/nylon/aluminium foil/polyester film and presented in an outer box.Pipettes are presented in boxes containing 1 pipette. Each pipette is individually sealed in a foil sachet.

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:
  • Norbrook Laboratories Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Manufacturing Limited
  • Norbrook Laboratories Limited
Responsible authority:
  • The Veterinary Medicines Directorate
Authorisation number:
  • Vm 02000/4413
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0366/002
Concerned member states:
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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