Veterinary Medicines

FYPERIX COMBO 402 MG/361,8 MG SPOT-ON SOLUTION FOR EXTRA LARGE DOGS

Authorised
  • Fipronil
  • Methoprene
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Product identification

Medicine name:
FYPERIX COMBO 402 MG/361,8 MG SPOT-ON SOLUTION FOR EXTRA LARGE DOGS
Amflee combo 402 mg/361,8 mg spot-on oplossing voor zeer grote honden
Active substance:
  • Fipronil
  • Methoprene
Target species:
  • Dog
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Fipronil
    402.00
    milligram(s)
    /
    1.00
    Pipette
  • Methoprene
    361.80
    milligram(s)
    /
    1.00
    Pipette
Pharmaceutical form:
  • Spot-on solution
Withdrawal period by route of administration:
  • Cutaneous 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:
  • Netherlands
Package description:
  • White polypropylene unit-dose pipette with polyethylene or polyoxymethylene closure with spike packaged into laminated triplex bag composed of polyester, aluminium and polyethylene. Cardboard box containing 3 pipettes.
  • White polypropylene unit-dose pipette with polyethylene or polyoxymethylene closure with spike packaged into laminated triplex bag composed of polyester, aluminium and polyethylene. Cardboard box containing 6 pipettes.
  • White polypropylene unit-dose pipette with polyethylene or polyoxymethylene closure with spike packaged into laminated triplex bag composed of polyester, aluminium and polyethylene. Cardboard box containing 10 pipettes.
  • White polypropylene unit-dose pipette with polyethylene or polyoxymethylene closure with spike packaged into laminated triplex bag composed of polyester, aluminium and polyethylene. Cardboard box containing 30 pipettes.
  • White polypropylene unit-dose pipette with polyethylene or polyoxymethylene closure with spike packaged into laminated triplex bag composed of polyester, aluminium and polyethylene. Cardboard box containing 1 pipette.

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:
  • Tad Pharma GmbH
  • Krka d.d. Novo Mesto
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 117513
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0333/005
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Estonia
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Spain
  • United Kingdom (Northern Ireland)

Documents

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Dutch (PDF)
Published on: 5/04/2022
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