Veterinary Medicines

FRADEXAM 6300 UI/ML + 0,760 MG/ML POUDRE ET SOLVANT POUR COLLYRE EN SOLUTION POUR CHIENS ET CHATS

Authorised
  • Framycetin sulfate
  • DEXAMETHASONE DISODIUM PHOSPHATE
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Product identification

Medicine name:
FRADEXAM 6300 UI/ML + 0,760 MG/ML POUDRE ET SOLVANT POUR COLLYRE EN SOLUTION POUR CHIENS ET CHATS
Active substance:
  • Framycetin sulfate
  • DEXAMETHASONE DISODIUM PHOSPHATE
Target species:
  • Dog
  • Cat
Route of administration:
  • Ocular use

Product details

Active substance and strength:
  • Framycetin sulfate
    6300.00
    international unit(s)
    /
    1.00
    millilitre(s)
  • DEXAMETHASONE DISODIUM PHOSPHATE
    1.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Eye drops, powder and solvent for solution
Withdrawal period by route of administration:
  • Ocular use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS01CA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Available in:
  • France
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Legal basis not covered by Directive 2001/82/EC
Marketing authorisation holder:
  • Domes Pharma
Marketing authorisation date:
Manufacturing sites for batch release:
  • Tubilux Pharma S.p.A.
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/0723213 0/1989
Date of authorisation status change:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 6/05/2025
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Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 6/05/2025
Download
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