FRADEXAM COLLYRE
FRADEXAM COLLYRE
Authorised
- Framycetin sulfate
- DEXAMETHASONE DISODIUM PHOSPHATE
Product identification
Medicine name:
FRADEXAM COLLYRE
Active substance:
- Framycetin sulfate
- DEXAMETHASONE DISODIUM PHOSPHATE
Target species:
-
Dog
-
Cat
Route of administration:
-
Ocular use
Product details
Active substance and strength:
-
Framycetin sulfate6300.00/international unit(s)1.00millilitre(s)
-
DEXAMETHASONE DISODIUM PHOSPHATE1.00/milligram(s)1.00millilitre(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:
- Available only in French
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:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
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: 8/12/2022
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: 30/04/2025
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