Veterinary Medicines

HIPRALONA ENRO-I 50 mg/ml injekčný roztok

Not authorised
  • Enrofloxacin
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Product identification

Medicine name:
HIPRALONA ENRO-I 50 mg/ml injekčný roztok
Active substance:
  • Enrofloxacin
Target species:
  • Cattle (calf)
  • Pig
Route of administration:
  • Intravenous use
  • Subcutaneous use
  • Intramuscular use

Product details

Active substance and strength:
  • Enrofloxacin
    50.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Cattle (calf)
      • Meat and offal
        5
        day
  • Subcutaneous use
    • Cattle (calf)
      • Meat and offal
        12
        day
  • Intramuscular use
    • Pig
      • Meat and offal
        13
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Slovakia
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:
  • Laboratorios Hipra S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Hipra S.A.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/026/03-S
Date of authorisation status change:

Documents

Combined File of all Documents

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Slovak (PDF)
Published on: 26/01/2022
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