Veterinary Medicine Information website

Enrox Max 100 mg/ml Injektionslösung für Rinder und Schweine

Authorised
  • Enrofloxacin
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Product identification

Medicine name:
Enrox Max 100 mg/ml Injektionslösung für Rinder und Schweine
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:
  • Germany
Package description:
  • Cardboard box with one amber glass multi-dose vial (Type II) containing 100 ml with bromobutyl rubber stopper and aluminium seal.

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:
  • TAD Pharma GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • KRKA tovarna zdravil d.d. Novo mesto
  • TAD Pharma GmbH
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 401896.00.00
Date of authorisation status change:
Reference member state:
  • Austria
Procedure number:
  • AT/V/0010/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

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German (PDF)
Published on: 20/12/2024
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