Orniflox 25 mg/ml Oral Solution for small mammals, birds and reptiles
Orniflox 25 mg/ml Oral Solution for small mammals, birds and reptiles
Authorised
- Enrofloxacin
Product identification
Medicine name:
Orniflox 25 mg/ml Oral Solution for small mammals, birds and reptiles
Orniflox 25 mg/ml Concentraat voor drank
Orniflox 25 mg/ml Solution à diluer pour solution buvable
Orniflox 25 mg/ml Konzentrat zur Herstellung einer Lösung zum Einnehmen
Active substance:
- Enrofloxacin
Target species:
-
Reptile
-
Ornamental bird
-
Rabbit
-
Rodents
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Enrofloxacin25.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Concentrate for oral solution
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01MA90
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Available in:
-
Belgium
Package description:
- 1 x 10 ml Type III amber glass bottles of 10 ml closed with tamper-evident HDPE screw caps with ring and colourless 1 ml dosing LDPE syringe insert in a carton box.
- 1 x 50 ml Type III amber glass bottles of 50 ml closed with tamper-evident HDPE screw caps with ring and colourless 5 ml dosing LDPE syringe insert in a carton box.
- 10 x (1 x 50 ml) Type III amber glass bottles of 50 ml closed with tamper-evident HDPE screw caps with ring and colourless 5 ml dosing LDPE syringe insert in a carton box.
- 10 x (1 x 10 ml) Type III amber glass bottles of 10 ml closed with tamper-evident HDPE screw caps with ring and colourless 1 ml dosing LDPE syringe insert in a carton box.
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Avimedical B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Floris Veterinaire Producten B.V.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V483057
Date of authorisation status change:
Reference member state:
-
Netherlands
Procedure number:
- NL/V/0294/001
Concerned member states:
-
Belgium
-
France
-
Germany
-
Ireland
-
Luxembourg
-
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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Package Leaflet
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Labelling
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