Veterinary Medicines

PestiGon Combo 67 mg / 60.3 mg spot-on solution for small dogs

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

Product identification

Medicine name:
PestiGon Combo 67 mg / 60.3 mg spot-on solution for small dogs
PestiGon Combo, 67 mg / 60,3 mg täpilahus väikestele koertele
Active substance:
  • (S)-Methoprene
  • Fipronil
Target species:
  • Dog
Route of administration:
  • Spot-on use

Product details

Active substance and strength:
  • (S)-Methoprene
    60.30
    milligram(s)
    /
    1.00
    Pipette
  • Fipronil
    67.00
    milligram(s)
    /
    1.00
    Pipette
Pharmaceutical form:
  • Spot-on solution
Withdrawal period by route of administration:
  • Spot-on use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AX65
Legal status of supply:
  • Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Estonia
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 sachet composed of LDPE/nylon/aluminium foil/polyester film and presented in an outer box.Boxes of 1 pipette. 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 sachet composed of LDPE/nylon/aluminium foil/polyester film and presented in an outer box.Boxes of 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 sachet composed of LDPE/nylon/aluminium foil/polyester film and presented in an outer box.Boxes of 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 sachet composed of LDPE/nylon/aluminium foil/polyester film and presented in an outer box.Boxes of 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 sachet composed of LDPE/nylon/aluminium foil/polyester film and presented in an outer box.Boxes of 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 sachet composed of LDPE/nylon/aluminium foil/polyester film and presented in an outer box.Boxes of 8 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 sachet composed of LDPE/nylon/aluminium foil/polyester film and presented in an outer box.Boxes of 12 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 sachet composed of LDPE/nylon/aluminium foil/polyester film and presented in an outer box.Boxes of 24 pipettes. 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 (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Laboratories Limited
  • Norbrook Manufacturing Limited
Responsible authority:
  • State Agency Of Medicines
Authorisation number:
  • 2023
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0363/002
Concerned member states:
  • Bulgaria
  • Estonia
  • France
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Portugal
  • Romania
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
Download
Estonian (PDF)
Published on: 14/03/2022
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."