Veterinary Medicines

Fluboral 200 mg/ml, suspension for use in drinking water for pigs and chickens

Authorised
  • Flubendazole
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Product identification

Medicine name:
Fluboral 200 mg/ml, suspension for use in drinking water for pigs and chickens
Fluboral, 200 mg/mL, suspenzija za primjenu u vodi za piće, za svinje i kokoši
Active substance:
  • Flubendazole
Target species:
  • Chicken
  • Pig
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Flubendazole
    200.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for use in drinking water
Withdrawal period by route of administration:
  • In drinking water use
    • Chicken
      • Eggs
        0
        day
      • Meat and offal
        2
        day
    • Pig
      • Meat and offal
        4
        day
      • Meat and offal
        5
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP52AC12
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Croatia
Available in:
  • Croatia
Package description:
  • Semi-transparent high density polyethylene bottle of 3 litre closed with white high density polyethylene screw-cap containing low density polyethylene sealing element.
  • Semi-transparent high density polyethylene bottle of 1 litre closed with white high density polyethylene screw-cap containing low density polyethylene sealing element.
  • Semi-transparent high density polyethylene bottle of 250 ml closed with white high density polyethylene screw-cap containing low density polyethylene sealing element.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • GENERA d.d.
Responsible authority:
  • Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
  • UP/I-322-05/22-01/758
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0664/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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Croatian (PDF)
Published on: 20/03/2023
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