Veterinary Medicines Information website

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
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:
  • Cyprus
Available in:
  • Cyprus
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:
  • Veterinary Services, Ministry Of Agriculture, Natural Resources And Environment
Authorisation number:
  • CY00897V
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)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Greek (PDF)
Published on: 25/09/2023
Updated on: 26/09/2023
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Summary of Product Characteristics

English (PDF)
Published on: 14/08/2023
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