Veterinary Medicines

Enrotron 100 mg/ml Solution for injection for cattle, sheep, goats and pigs

Authorised
  • Enrofloxacin
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Product identification

Medicine name:
Enrotron 100 mg/ml Solution for injection for cattle, sheep, goats and pigs
ENROTRON 100 mg/ml soluție injectabilă pentru bovine și porcine
Active substance:
  • Enrofloxacin
Target species:
  • Pig
  • Cattle
  • Goat
  • Sheep
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
        13
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        5
        day
      • Milk
        3
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        12
        day
      • Milk
        4
        day
    • Goat
      • Meat and offal
        6
        day
      • Milk
        4
        day
    • Sheep
      • Meat and offal
        4
        day
      • Milk
        3
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
Available in:
  • Romania
Package description:
  • Pack Size: 100 ml clear glass vial type I with siliconised, Teflon coated rubber stopper sealed with an aluminium cap.Cartons of 12 x 100 ml are available.
  • Pack Size: 100 ml clear glass vial type I with siliconised, Teflon coated rubber stopper sealed with an aluminium cap.Carton of 1 x 100 ml is available.
  • Pack Size: 100 ml clear glass vial type I with siliconised, uncoated bromobutyl rubber stopper, sealed with an aluminium cap.Carton of 1 x 100 ml is available.
  • Pack Size: 100 ml clear glass vial type I with siliconised, uncoated bromobutyl rubber stopper, sealed with an aluminium cap.Cartons of 12 x 100 ml are available.
  • Pack Size: 250 ml clear glass vial type I with siliconised, uncoated bromobutyl rubber stopper, sealed with an aluminium cap.Carton of 1 x 250 ml is available.
  • Pack Size: 250 ml clear glass vial type I with siliconised, uncoated bromobutyl rubber stopper, sealed with an aluminium cap.Cartons of 12 x 250 ml are available.

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:
  • aniMedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • aniMedica GmbH
  • Industrial Veterinaria S.A.
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 190062
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0270/003
Concerned member states:
  • Estonia
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Poland
  • Portugal
  • Romania
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 7/09/2025
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Romanian (PDF)
Published on: 5/11/2025
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Summary of Product Characteristics

English (PDF)
Published on: 16/01/2026
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