Veterinary Medicine Information website

Enrotril Max 100 mg/ml Solution for Injection for Cattle

Authorised
  • Enrofloxacin
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Product identification

Medicine name:
Enrotril Max 100 mg/ml Solution for Injection for Cattle
Active substance:
  • Enrofloxacin
Target species:
  • Cattle
Route of administration:
  • 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:
  • Subcutaneous use
    • Cattle
      • Meat and offal
        14
        day
      • Milk
        84
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
Package description:
  • 500 ml amber Type I glass vial with a grey bromobutyl rubber stopper and aluminium overseal. 500 ml vial sold in packs containing 12 x 500 ml.
  • 500 ml amber Type I glass vial with a grey bromobutyl rubber stopper and aluminium overseal. 500 ml vial sold in packs containing 4 x 500 ml.
  • 500 ml amber Type I glass vial with a grey bromobutyl rubber stopper and aluminium overseal. 500 ml vial sold in packs containing 1 x 500 ml.
  • 250 ml amber Type I glas vials with a grey bromobutyl rubber stopper and aluminium overseal. 250 ml vial sold in packs containing 12 x 250 ml.
  • 250 ml amber Type I glass vial with a grey bromobutyl rubber stopper and aluminium overseal. 250 ml vial sold in packs containing 4 x 250 ml.
  • 250 ml amber Type I glass vial with a grey bromobutyl rubber stopper and aluminium overseal. 250 ml vial sold in packs containing 1 x 250 ml.
  • 100 ml amber Type I glass vial with a grey bromobutyl rubber stopper and aluminium overseal. 100 ml vial sold in packs containing 12 x 100 ml.
  • 100 ml amber Type I glass vial with a grey bromobutyl rubber stopper and aluminium overseal. 100 ml vial sold in packs containing 4 x 100 ml.
  • 100 ml amber Type I glass vial with a grey bromobutyl rubber stopper and aluminium overseal. 100 ml vial sold in packs containing 1 x 100 ml.

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:
  • Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Manufacturing Limited
  • Norbrook Laboratories Limited
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 190143
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0557/001
Concerned member states:
  • Austria
  • Czechia
  • Estonia
  • Greece
  • Latvia
  • Lithuania
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 28/01/2022
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Romanian (PDF)
Published on: 21/03/2022
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