Veterinary Medicines

Baytril Direct 100 mg/ml Injektionslösung für Rinder und Schweine

Authorised
  • Enrofloxacin
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Product identification

Medicine name:
Baytril Direct 100 mg/ml Injektionslösung für Rinder und Schweine
BAYTRIL INJECT
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:
  • Italy
Available in:
  • Italy
Package description:
  • Cardboard box with one brown glass bottle (Type I) containing 100 ml 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 Italia S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • KVP Pharma+Veterinaer Produkte GmbH
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 104321
Date of authorisation status change:
Reference member state:
  • Austria
Procedure number:
  • AT/V/0007/002
Concerned member states:
  • Germany
  • Ireland
  • Italy
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

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Italian (PDF)
Published on: 3/06/2022
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