Veterinary Medicines

Enrobactin 25 mg/ml concentrate for oral solution for pet rabbits, rodents, ornamental birds and reptiles

Authorised
  • Enrofloxacin
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Product identification

Medicine name:
Enrobactin 25 mg/ml concentrate for oral solution for pet rabbits, rodents, ornamental birds and reptiles
Enrobactin 25 mg/ml Concentraat voor drank
Enrobactin 25 mg/ml Solution à diluer pour solution buvable
Enrobactin 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:
  • 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:
  • Belgium
Package description:
  • 30 ml amber type III glass bottles closed with tamper-evident HDPE/LDPE screw caps with ring and colourless LDPE syringe (5 ml dosing syringe) insert in a carton box containing 30 ml
  • 10 x (1x50 ml) amber type III glass bottles closed with tamper-evident HDPE/LDPE screw caps with ring and colourless LDPE syringe (5 ml dosing syringe) insert in a carton box containing 50 ml
  • 50 ml amber type III glass bottles closed with tamper-evident HDPE/LDPE screw caps with ring and colourless LDPE syringe (5 ml dosing syringe) insert in a carton box containing 50 ml
  • 10 x 1x30 ml amber type III glass bottles closed with tamper-evident HDPE/LDPE screw caps with ring and colourless LDPE syringe (5 ml dosing syringe) insert in a carton box containing 30 ml
  • 10 x 1x10 ml amber type III glass bottles closed with tamper-evident HDPE/LDPE screw caps with ring and colourless LDPE syringe (1 ml dosing syringe) insert in a carton box containing 10 ml
  • 10 ml amber type III glass bottles closed with tamper-evident HDPE/LDPE screw caps with ring and colourless LDPE syringe (1 ml dosing syringe) insert in a carton box containing 10 ml

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:
  • Dechra Regulatory 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-V478844
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0315/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/03/2022
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French (PDF)
Published on: 22/03/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/03/2022
Download
French (PDF)
Published on: 22/03/2022
Download
German (PDF)
Published on: 22/03/2022
Download
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