Veterinary Medicine Information website

Enrocare 100 mg/ml Solution for Injection for Cattle and Pigs

Authorised
  • Enrofloxacin
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Product identification

Medicine name:
Enrocare 100 mg/ml Solution for Injection for Cattle and Pigs
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
        13
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        5
        day
      • Milk
        3
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        12
        day
      • Milk
        4
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Package description:
  • 100 ml Amber Type I multidose glass vial with a grey bromobutyl rubber stopper and aluminium overseal.100 ml vial sold in packs containing 1 x 100 ml cartons.
  • 100 ml Amber Type I multidose glass vial with a grey bromobutyl rubber stopper and aluminium overseal.100 ml vial sold in packs containing 6 x 100 ml cartons.
  • 100 ml Amber Type I multidose glass vial with a grey bromobutyl rubber stopper and aluminium overseal.100 ml vial sold in packs containing 12 x 100 ml cartons.
  • 250 ml Amber Type I multidose glass vial with a grey bromobutyl rubber stopper and aluminium overseal.250 ml vial sold in packs containing 1 x 250 ml cartons.
  • 250 ml Amber Type I multidose glass vial with a grey bromobutyl rubber stopper and aluminium overseal.250 ml vial sold in packs containing 6 x 250 ml cartons.
  • 250 ml Amber Type I multidose glass vial with a grey bromobutyl rubber stopper and aluminium overseal.250 ml vial sold in packs containing 12 x 250 ml cartons.

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:
  • Emdoka
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 104354
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0455/003
Concerned member states:
  • Luxembourg
  • Netherlands
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 26/01/2022
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Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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