Veterinary Medicines

Baytril One 100 mg/ml Injektionslösung für Rinder und Schweine

Authorised
  • Enrofloxacin
Download as PDF

Product identification

Medicine name:
Baytril One 100 mg/ml Injektionslösung für Rinder und Schweine
Baytril Max, 100 mg/mL, otopina za injekciju, za goveda i svinje
Active substance:
  • Enrofloxacin
Target species:
  • Pig
  • Cattle
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Enrofloxacin
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        12
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        7
        day
      • Milk
        72
        hour
  • Subcutaneous use
    • Cattle
      • Meat and offal
        14
        day
      • Milk
        120
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Croatia
Available in:
  • Croatia
Package description:
  • Cardboard box with 1 brown glass bottle (glass type I, Ph. Eur.) of 100 ml with butyl rubber stopper and aluminium crimp cap.

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:
  • Elanco Animal Health GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • KVP Pharma+Veterinär Produkte GmbH
Responsible authority:
  • Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
  • UP/I-322-05/18-01/334
Date of authorisation status change:
Reference member state:
  • Austria
Procedure number:
  • AT/V/0001/001
Concerned member states:
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Greece
  • Poland
  • Portugal
  • Slovakia
  • Slovenia
  • Spain

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Croatian (PDF)
Published on: 26/03/2024
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."