Veterinary Medicine Information website

Noromectin 10 mg/ml Solution for Injection for Cattle and Pigs

Authorised
  • Ivermectin
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Product identification

Medicine name:
Noromectin 10 mg/ml Solution for Injection for Cattle and Pigs
Active substance:
  • Ivermectin
Target species:
  • Cattle
  • Pig
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Ivermectin
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • Meat and offal
        49
        day
    • Pig
      • Meat and offal
        18
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Available in:
  • Netherlands
Package description:
  • The product will be supplied in 1 L volume, presented in high-density polyethylene vial with bromobutyl bung and aluminium cap.
  • The product will be supplied in 500 ml volume, presented in high-density polyethylene vial with bromobutyl bung and aluminium cap.
  • The product will be supplied in 250 ml volume, presented in high-density polyethylene vial with bromobutyl bung and aluminium cap.
  • The product will be supplied in 100 ml volume, presented in high-density polyethylene vial with bromobutyl bung and aluminium cap.
  • The product will be supplied in 50 ml volume, presented in high-density polyethylene vial with bromobutyl bung and aluminium cap.

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 Laboratories Limited
  • Norbrook Laboratories (Ireland) Limited
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 10107
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0104/001
Concerned member states:
  • France
  • Germany
  • Greece
  • Iceland
  • Italy
  • Netherlands
  • Portugal
  • Spain

Documents

Combined File of all Documents

English (PDF)
Published on: 29/12/2024
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Dutch (PDF)
Published on: 25/06/2025
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Summary of Product Characteristics

English (PDF)
Published on: 29/12/2024
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ie-puar-mr-iev0104001-noromectin-1-wv-solution-for-injection-for-cattle--en.pdf

English (PDF)
Published on: 29/12/2024
Download