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, koncentrat za oralnu otopinu, za kuniće kućne ljubimce, glodavce, ukrasne ptice i gmazove
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
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Croatia
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:
  • Le Vet. Beheer B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Floris Veterinaire Producten B.V.
Responsible authority:
  • Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
  • UP/I-322-05/21-01/49
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

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Croatian (PDF)
Published on: 24/03/2022
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