Veterinary Medicines

FYPERIX COMBO 67 MG/60,3 MG SPOT-ON SOLUTION FOR SMALL DOGS

Authorised
  • Fipronil
  • Methoprene
Download as PDF

Product identification

Medicine name:
FYPERIX COMBO 67 MG/60,3 MG SPOT-ON SOLUTION FOR SMALL DOGS
Fyperix combo 67 mg/ 60,3 mg solução para unção punctiforme para cães pequenos
Active substance:
  • Fipronil
  • Methoprene
Target species:
  • Dog
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Fipronil
    67.00
    milligram(s)
    /
    1.00
    Pipette
  • Methoprene
    60.30
    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:
  • Portugal
Available in:
  • Portugal
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 tovarna zdravil d.d. Novo mesto
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 1187/02/18DFVPT
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0333/002
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Estonia
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Portuguese (PDF)
Published on: 13/02/2025
Download