Veterinary Medicines Information website

DIXIE 268 mg spot-on solution for large dogs

Authorised
  • Fipronil
Download as PDF

Product identification

Medicine name:
DIXIE 268 mg spot-on solution for large dogs
Active substance:
  • Fipronil
Target species:
  • Dog
Route of administration:
  • Spot-on use

Product details

Active substance and strength:
  • Fipronil
    268.00
    milligram(s)
    /
    1.00
    Pipette
Pharmaceutical form:
  • Spot-on solution
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AX15
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:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Quimica De Munguia S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ab7 Sante
  • Quimica De Munguia S.A.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2865
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0308/003
Concerned member states:
  • France
  • Greece
  • Italy
  • Poland
  • Portugal
  • Romania
  • United Kingdom (Northern Ireland)

Documents

Package Leaflet

English (PDF)
Published on: 11/04/2023
Download
Polish (PDF)
Published on: 4/02/2022
Download

Summary of Product Characteristics

English (PDF)
Published on: 11/04/2023
Download
Polish (PDF)
Published on: 4/02/2022
Download

Labelling

English (PDF)
Published on: 11/04/2023
Download
Polish (PDF)
Published on: 4/02/2022
Download

eu-PUAR-dixie-268-mg-spot-on-solution-for-large-dogs-en.pdf

English (PDF)
Published on: 11/04/2023
Download