Veterinary Medicines Information website

DIXIE 134 mg spot-on solution for medium dogs

Authorised
  • Fipronil
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Product identification

Medicine name:
DIXIE 134 mg spot-on solution for medium dogs
Active substance:
  • Fipronil
Target species:
  • Dog
Route of administration:
  • Spot-on use

Product details

Active substance and strength:
  • Fipronil
    134.00
    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:
  • Italy
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:
  • Ministry Of Health
Authorisation number:
  • 105268
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0308/002
Concerned member states:
  • France
  • Greece
  • Italy
  • Poland
  • Portugal
  • Romania
  • 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.
Italian (PDF)
Published on: 3/06/2022
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Summary of Product Characteristics

English (PDF)
Published on: 11/04/2023
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Package Leaflet

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

English (PDF)
Published on: 11/04/2023
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eu-PUAR-dixie-134-mg-spot-on-solution-for-medium-dogs-en.pdf

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