Veterinary Medicines

Amflee Combo 402 mg/361.8 mg spot-on solution for extra large dogs

Authorised
  • (S)-Methoprene
  • Fipronil
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Product identification

Medicine name:
Amflee Combo 402 mg/361.8 mg spot-on solution for extra large dogs
Fypermid combo 402 mg/ 361,8 soluzione spot-on per cani di taglia gigante
Active substance:
  • (S)-Methoprene
  • Fipronil
Target species:
  • Dog
Route of administration:
  • Spot-on use

Product details

Active substance and strength:
  • (S)-Methoprene
    361.80
    milligram(s)
    /
    1.00
    Pipette
  • Fipronil
    402.00
    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:
  • Italy
Available in:
  • Italy
Package description:
  • White polypropylene single-dose pipette packaged in aluminium foil sachets.Cardboard box containing 1 pipette.
  • White polypropylene single-dose pipette packaged in aluminium foil sachets.Cardboard box containing 3 pipettes.
  • White polypropylene single-dose pipette packaged in aluminium foil sachets.Cardboard box containing 6 pipettes.
  • White polypropylene single-dose pipette packaged in aluminium foil sachets.Cardboard box containing 30 pipettes.

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:
  • KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
  • KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 105150
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0451/005
Concerned member states:
  • Belgium
  • Cyprus
  • Finland
  • Italy
  • Portugal
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 19/01/2025
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Italian (PDF)
Published on: 14/06/2024
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Summary of Product Characteristics

English (PDF)
Published on: 19/01/2025
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