Veterinary Medicines

ZORABEL 50 mg/ml Oral Suspension for pigs

Not authorised
  • Toltrazuril
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Product identification

Medicine name:
ZORABEL 50 mg/mL ORAL SUSPENSION FOR PIGS.
ZORABEL 50 mg/ml Oral Suspension for pigs
Active substance:
  • Toltrazuril
Target species:
  • Pig (piglet)
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Toltrazuril
    50.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral suspension
Withdrawal period by route of administration:
  • Oral use
    • Pig (piglet)
      • Meat and offal
        73
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP51AJ01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Ireland
Package description:
  • bottle of 1 L
  • box containing 15 bottles of 250 ml
  • box containing 1 bottle of 250 ml
  • box containing 1 bottle of 100 ml

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:
  • Vetpharma Animal Health S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Mevet S.A.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10516/024/001
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0194/001

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/04/2023
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Package Leaflet

English (PDF)
Published on: 11/04/2023
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Labelling

English (PDF)
Published on: 11/04/2023
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Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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eu-PUAR-zorabel--50-mg-ml-oral-suspension-for-pigs.-en.pdf

English (PDF)
Published on: 11/04/2023
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