Veterinary Medicines

Orniflox 25 mg/ml Oral Solution for small mammals, birds and reptiles

Authorised
  • Enrofloxacin
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Product identification

Medicine name:
Orniflox 25 mg/ml Oral Solution for small mammals, birds and reptiles
ORNIFLOX 25 MG/ML SOLUTION A DILUER POUR SOLUTION BUVABLE POUR LAPINS DE COMPAGNIE, RONGEURS, OISEAUX D'ORNEMENT ET REPTILES
Active substance:
  • Enrofloxacin
Target species:
  • Reptile
  • Ornamental bird
  • Rabbit
  • Rodents
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Enrofloxacin
    25.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Concentrate for oral solution
Withdrawal period by route of administration:
  • Oral use
    • Reptile
    • Ornamental bird
    • Rabbit
    • Rodents
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
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:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/1078206 0/2015
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)

Documents

Summary of Product Characteristics

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French (PDF)
Published on: 7/04/2022
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