Cefenidex CA/DEX 2 mg/ml + 1 mg/ml eye drops, solution for dogs and cats
Cefenidex CA/DEX 2 mg/ml + 1 mg/ml eye drops, solution for dogs and cats
Authorised
- Dexamethasone sodium phosphate
- Chloramphenicol
Product identification
Medicine name:
Cefenidex CA/DEX 2 mg/ml + 1 mg/ml eye drops, solution for dogs and cats
Cepfenidex 2 mg/ml + 1 mg/ml collyre en solution pour chiens et chats
Cepfenidex 2 mg/ml + 1 mg/ml oogdruppels, oplossing voor honden en katten
Cepfenidex 2 mg/ml + 1 mg/ml Augentropfen, Lösung für Hunde und Katzen
Active substance:
- Dexamethasone sodium phosphate
- Chloramphenicol
Target species:
-
Dog
-
Cat
Route of administration:
-
Ocular use
Product details
Active substance and strength:
-
Dexamethasone sodium phosphate1.32/milligram(s)1.00millilitre(s)
-
Chloramphenicol2.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Eye drops, solution
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QS01CA01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- (ID1) 10 millilitre(s): Box (Cardboard) with 1 Bottle (Low Density PolyEthylene) with 10 millilitre(s), closed with Screw cap (High Density PolyEthylene)
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6)
Marketing authorisation holder:
- CP-Pharma Handelsgesellschaft mbH
Marketing authorisation date:
Manufacturing sites for batch release:
- CP-Pharma Handelsgesellschaft mbH
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V663397
Date of authorisation status change:
Reference member state:
-
Germany
Procedure number:
- DE/V/0343/001
Concerned member states:
-
Austria
-
Belgium
-
Denmark
-
Estonia
-
Finland
-
France
-
Greece
-
Hungary
-
Ireland
-
Italy
-
Latvia
-
Lithuania
-
Netherlands
-
Norway
-
Poland
-
Portugal
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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Labelling
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Package Leaflet
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