Veterinary Medicines

DIXIE 402 mg spot-on solution for very large dogs

Authorised
  • Fipronil
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Product identification

Medicine name:
DIXIE 402 mg spot-on solution for very large dogs
DIXIE 402 mg soluție spot-on pentru câini de talie foarte mare
Active substance:
  • Fipronil
Target species:
  • Dog
Route of administration:
  • Spot-on use

Product details

Active substance and strength:
  • Fipronil
    402.00
    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:
  • Romania
Package description:
  • cardboard box containing 150 pipettes of 4,02 ml
  • cardboard box containing 120 pipettes of 4,02 ml
  • cardboard box containing 90 pipettes of 4,02 ml
  • cardboard box containing 60 pipettes of 4,02 ml
  • cardboard box containing 30 pipettes of 4,02 ml
  • cardboard box containing 24 pipettes of 4,02 ml
  • cardboard box containing 12 pipettes of 4,02 ml
  • cardboard box containing 10 pipettes of 4,02 ml
  • cardboard box containing 8 pipettes of 4,02 ml
  • cardboard box containing 6 pipettes of 4,02 ml
  • cardboard box containing 5 pipettes of 4,02 ml
  • cardboard box containing 4 pipettes of 4,02 ml
  • cardboard box containing 3 pipettes of 4,02 ml
  • cardboard box containing 2 pipettes of 4,02 ml
  • cardboard box containing 1 pipette of 4,02 ml

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:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 240020
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0308/004
Concerned member states:
  • France
  • Greece
  • Italy
  • Poland
  • Portugal
  • Romania
  • United Kingdom (Northern Ireland)

Documents

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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Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Romanian (PDF)
Published on: 21/02/2025
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eu-PUAR-dixie-402-mg-spot-on-solution-for-very-large-dogs-en.pdf

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