Veterinary Medicines

DOZURIL 25 mg/ml oral solution for chicken

Authorised
  • Toltrazuril
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Product identification

Medicine name:
DOZURIL 25 mg/ml oral solution for chicken
Dozuril 25 mg/ml Roztwór do podania w wodzie do picia
Active substance:
  • Toltrazuril
Target species:
  • Chicken
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Toltrazuril
    25.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for use in drinking water
Withdrawal period by route of administration:
  • In drinking water use
    • Chicken
      • Meat and offal
        16
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP51AJ01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:
  • 5 litre high-density polyethylene barrels with high-density polyethylene screw cap and removable polyethylene sealing disk.
  • 1 litre high-density polyethylene bottles with high-density polyethylene screw cap and removable polyethylene sealing disk.

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:
  • Dopharma Research B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Dopharma B.V.
  • Dopharma France
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2212
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0216/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Denmark
  • Estonia
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Latvia
  • Lithuania
  • Poland
  • Romania

Documents

Summary of Product Characteristics

English (PDF)
Published on: 23/05/2023
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Polish (PDF)
Published on: 6/02/2023
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 6/02/2023
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Package Leaflet and Labelling

English (PDF)
Published on: 23/05/2023
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PuAR Dozuril NL-V-0216-001.pdf

English (PDF)
Published on: 23/05/2023
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