Veterinary Medicines

Fyperix 402 mg spot-on solution for dogs

Authorised
  • Fipronil
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Product identification

Medicine name:
Fyperix 402 mg spot-on solution for dogs
FYPERIX 402 mg SOLUCION PARA UNCION DORSAL PUNTUAL PARA PERROS
Active substance:
  • Fipronil
Target species:
  • Dog
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Fipronil
    402.00
    milligram(s)
    /
    4.02
    millilitre(s)
Pharmaceutical form:
  • Spot-on solution
Withdrawal period by route of administration:
  • Cutaneous use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AX15
Legal status of supply:
  • Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:
  • (ID6) 120.6 millilitre(s): Box (Cardboard) with 30 Beutel (Low Density PolyEthylene; PolyEthylene TerePhthalate; Aluminium) each with 1 Pipette (PolyPropylene) with 4.02 millilitre(s)
  • (ID5) 80.4 millilitre(s): Box (Cardboard) with 20 Beutel (Low Density PolyEthylene; PolyEthylene TerePhthalate; Aluminium) each with 1 Pipette (PolyPropylene) with 4.02 millilitre(s)
  • (ID4) 40.2 millilitre(s): Box (Cardboard) with 10 Beutel (Low Density PolyEthylene; PolyEthylene TerePhthalate; Aluminium) each with 1 Pipette (PolyPropylene) with 4.02 millilitre(s)
  • (ID3) 24.12 millilitre(s): Box (Cardboard) with 6 Beutel (Low Density PolyEthylene; PolyEthylene TerePhthalate; Aluminium) each with 1 Pipette (PolyPropylene) with 4.02 millilitre(s)
  • (ID2) 12.06 millilitre(s): Box (Cardboard) with 3 Beutel (Low Density PolyEthylene; PolyEthylene TerePhthalate; Aluminium) each with 1 Pipette (PolyPropylene) with 4.02 millilitre(s)
  • (ID1) 4.02 millilitre(s): Box (Cardboard) with Beutel (Low Density PolyEthylene; PolyEthylene TerePhthalate; Aluminium) with 1 Pipette (PolyPropylene) with 4.02 millilitre(s)

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:
  • KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
  • KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 2598 ESP
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0190/005
Concerned member states:
  • Finland
  • France
  • Italy
  • Portugal
  • Spain
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