Veterinary Medicines

Baytril Direct 100 mg/ml - Injektionslösung für Schweine

Authorised
  • Enrofloxacin
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Product identification

Medicine name:
Baytril Direct 100 mg/ml - Injektionslösung für Schweine
Baytril Direct 100 mg/ml - Injektionslösung für Schweine
Active substance:
  • Enrofloxacin
Target species:
  • Pig
Route of administration:
  • Intramuscular 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
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA90
Legal status of supply:
  • Medicinal product on medical prescription for non-renewable delivery
Authorisation status:
  • Valid
Authorised in:
  • Austria
Package description:
  • Carton box containing one 100 ml brown glass (Type 1) bottle with chlorobutyl rubber stopper secured by an 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:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 8-00988
Date of authorisation status change:
Reference member state:
  • Austria
Procedure number:
  • AT/V/0007/001
Concerned member states:
  • Belgium
  • Luxembourg
  • Netherlands

Documents

Summary of Product Characteristics

English (PDF)
Published on: 23/06/2021
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German (PDF)
Published on: 21/02/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 21/02/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 21/02/2024
Download

at-puar-atv0007001-mr-baeytril-en.pdf

English (PDF)
Published on: 27/02/2024
Download

at-puar-atv0007001-mr-baeytril-de.pdf

German (PDF)
Published on: 27/02/2024
Download
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