Veterinary Medicine Information website

Toltarox 50 mg/ml oral suspension for pigs

Authorised
  • Toltrazuril
Download as PDF

Product identification

Medicine name:
Toltarox 50 mg/ml oral suspension for pigs
Active substance:
  • Toltrazuril
Target species:
  • 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
    • 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:
  • Romania
Available in:
  • Romania
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:
  • Virbac
  • KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 160150
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0247/001
Concerned member states:
  • Belgium
  • Denmark
  • Finland
  • Germany
  • Romania
  • Slovenia
  • Sweden

Documents

Summary of Product Characteristics

English (PDF)
Published on: 10/05/2026
Download
Romanian (PDF)
Published on: 9/05/2022
Download

Combined File of all Documents

English (PDF)
Published on: 10/05/2026
Download