Veterinary Medicine Information website

Toltarox 50 mg/ml oral suspension for cattle

Authorised
  • Toltrazuril
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Product identification

Medicine name:
Toltarox 50 mg/ml oral suspension for cattle
Active substance:
  • Toltrazuril
Target species:
  • Cattle
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
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP51AJ01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovenia
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:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • DC/V/0335/002
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0247/002
Concerned member states:
  • Romania
  • Slovenia

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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Slovenian (PDF)
Published on: 3/03/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 3/03/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 3/03/2022
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