Veterinary Medicines

Tylolab tartrate 200,000 IU/ml solution for injection

Authorised
  • Tylosin tartrate
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Product identification

Medicine name:
Tylolab tartrate 200,000 IU/ml solution for injection
Tylolab tartrate 200.000 IU/ml ενέσιμο διάλυμα
Active substance:
  • Tylosin tartrate
Target species:
  • Cattle
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Tylosin tartrate
    200000.00
    international unit(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        33
        day
      • Milk
        120
        hour
    • Pig
      • Meat and offal
        21
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01FA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Greece
Available in:
  • Greece
Package description:
  • Amber type II glass vials containing 250 mL veterinary medicinal product, closed with a chlorobutyl stopper and aluminium caps.
  • Amber type II glass vials containing 250 mL veterinary medicinal product, closed with a chlorobutyl stopper and aluminium caps.
  • Amber type II glass vials containing 250 mL veterinary medicinal product, closed with a chlorobutyl stopper and aluminium caps.
  • Amber type II glass vials containing 100 mL veterinary medicinal product, closed with a chlorobutyl stopper and aluminium caps.
  • Amber type II glass vials containing 100 mL veterinary medicinal product, closed with a chlorobutyl stopper and aluminium caps.

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:
  • Labiana Life Sciences S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Labiana Life Sciences S.A.
Responsible authority:
  • National Organization For Medicines
Authorisation number:
  • 62551/13.06.2023/27-07-2023/K-0252201
Date of authorisation status change:
Reference member state:
  • Hungary
Procedure number:
  • HU/V/0147/001
Concerned member states:
  • Cyprus
  • France
  • Greece
  • Ireland
  • Romania
  • United Kingdom (Northern Ireland)