Veterinary Medicines

FYPERIX COMBO 268 MG/241,2 MG SPOT-ON SOLUTION FOR LARGE DOGS

Authorised
  • Fipronil
  • Methoprene
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Product identification

Medicine name:
FYPERIX COMBO 268 MG/241,2 MG SPOT-ON SOLUTION FOR LARGE DOGS
Amflee Combo 268 mg / 2,68 ml + 241,2 mg / 2,68 ml Roztwór do nakrapiania
Active substance:
  • Fipronil
  • Methoprene
Target species:
  • Dog
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Fipronil
    268.00
    milligram(s)
    /
    1.00
    Pipette
  • Methoprene
    241.20
    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:
  • Poland
Package description:

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:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2718
Reference member state:
  • France
Procedure number:
  • FR/V/0333/004
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Estonia
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 13/04/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 13/04/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 13/04/2022
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