Veterinary Medicines

Tylo 200 mg/ml solution for injection

Authorised
  • Tylosin tartrate
Download as PDF

Product identification

Medicine name:
Tylo 200 mg/ml solution for injection
Active substance:
  • Tylosin tartrate
Target species:
  • Cattle
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Tylosin tartrate
    232.77
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        28
        day
      • Milk
        7
        day
    • Pig
      • Meat and offal
        28
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01FA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Available in:
  • Ireland
Package description:
  • Round Type II amber glass vials of 100 ml with bromobutyl rubber stopper, sealed with aluminium cap.The vials are packed in a polystyrene box, 12 vials of 100 ml per box, wiht 12 package leaflets.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Informed consent (abridged application) - Council Directive 81/851/EEC
Marketing authorisation holder:
  • KELA Kempisch Laboratorium Kela Laboratoria
Marketing authorisation date:
Manufacturing sites for batch release:
  • KELA Kempisch Laboratorium Kela Laboratoria
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10981/004/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
Download