Veterinary Medicines

ORATIL-100

Authorised
  • Tylosin tartrate
Download as PDF

Product identification

Medicine name:
ORATIL-100
Active substance:
  • Tylosin tartrate
Target species:
  • Chicken (hen)
  • Turkey
  • Pig
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Tylosin tartrate
    108.18
    gram(s)
    /
    100.00
    gram(s)
Pharmaceutical form:
  • Oral powder
Withdrawal period by route of administration:
  • In drinking water use
    • Chicken (hen)
      • Meat and offal
        2
        day
    • Turkey
      • Meat and offal
        2
        day
    • Pig
      • Meat and offal
        2
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01FA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Bulgaria
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Farma Sis OOD
Marketing authorisation date:
Manufacturing sites for batch release:
  • S P Veterinaria S.A.
  • Cenavisa S.L.
Responsible authority:
  • Bulgarian Food Safety Authority
Authorisation number:
  • 0022-2336
Date of authorisation status change:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 29/04/2025
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 29/04/2025
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 29/04/2025
Download