Veterinary Medicines

Fyperix 134 mg spot-on solution for dogs

Authorised
  • Fipronil
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Product identification

Medicine name:
Fyperix 134 mg spot-on solution for dogs
Fyperix 134 mg solução para unção punctiforme para cães
Active substance:
  • Fipronil
Target species:
  • Dog
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Fipronil
    134.00
    milligram(s)
    /
    0.67
    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:
  • Portugal
Package description:
  • (ID6) 1206 millilitre(s): Box (Cardboard) with 30 Beutel (PolyEthylene TerePhthalate; Aluminium; Low Density PolyEthylene) each with 30 Pipette (PolyPropylene) each with 1.34 millilitre(s)
  • (ID5) 536 millilitre(s): Box (Cardboard) with 20 Beutel (PolyEthylene TerePhthalate; Aluminium; Low Density PolyEthylene) each with 20 Pipette (PolyPropylene) each with 1.34 millilitre(s)
  • (ID4) 134 millilitre(s): Box (Cardboard) with 10 Beutel (PolyEthylene TerePhthalate; Aluminium; Low Density PolyEthylene) each with 10 Pipette (PolyPropylene) each with 1.34 millilitre(s)
  • (ID3) 48.24 millilitre(s): Box (Cardboard) with 6 Beutel (PolyEthylene TerePhthalate; Aluminium; Low Density PolyEthylene) each with 6 Pipette (PolyPropylene) each with 1.34 millilitre(s)
  • (ID2) 12.06 millilitre(s): Box (Cardboard) with 3 Beutel (PolyEthylene TerePhthalate; Aluminium; Low Density PolyEthylene) each with 3 Pipette (PolyPropylene) each with 1.34 millilitre(s)
  • (ID1) 1.34 millilitre(s): Box (Cardboard) with Beutel (PolyEthylene TerePhthalate; Aluminium; Low Density PolyEthylene) with 1 Pipette (PolyPropylene) with 1.34 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 d.d. Novo Mesto
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 474/03/12DFVPT
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0190/003
Concerned member states:
  • Finland
  • France
  • Italy
  • Portugal
  • Spain

Documents

Summary of Product Characteristics

English (PDF)
Published on: 15/02/2022
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