Veterinary Medicine Information website

Tolracol 50 mg/ml oral suspension for pigs, cattle and sheep

Authorised
  • Toltrazuril
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Product identification

Medicine name:
Tolracol 50 mg/ml oral suspension for pigs, cattle and sheep
Active substance:
  • Toltrazuril
Target species:
  • Cattle
  • Sheep
  • Pig
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
    • Cattle
      • Meat and offal
        63
        day
    • Sheep
      • Meat and offal
        42
        day
    • Pig
      • Meat and offal
        77
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP51AJ01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Available in:
  • Belgium
Package description:
  • Bottle (HDPE), closure (HDPE), sealing liner (LDPE): 1000 ml of oral suspension.
  • Bottle (HDPE), closure (HDPE), sealing liner (LDPE): 250 ml of oral suspension, in a 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:
  • KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
  • KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V468746
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0333/001
Concerned member states:
  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 22/02/2026
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Dutch (PDF)
Published on: 8/04/2026
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French (PDF)
Published on: 8/04/2026
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German (PDF)
Published on: 8/04/2026
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 8/04/2026
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German (PDF)
Published on: 8/04/2026
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Dutch (PDF)
Published on: 8/04/2026
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Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 8/04/2026
Download
German (PDF)
Published on: 8/04/2026
Download
Dutch (PDF)
Published on: 8/04/2026
Download

Combined File of all Documents

English (PDF)
Published on: 22/02/2026
Download