Veterinary Medicines

Noroclav Injection for Cattle and Dogs

Authorised
  • Amoxicillin trihydrate
  • Potassium clavulanate
Download as PDF

Product identification

Medicine name:
Noroclav Injection for Cattle and Dogs
Noroclav Injection for Cattle and Dogs
Active substance:
  • Amoxicillin trihydrate
  • Potassium clavulanate
Target species:
  • Cattle
  • Dog
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Amoxicillin trihydrate
    16.07
    gram(s)
    /
    100.00
    millilitre(s)
  • Potassium clavulanate
    4.17
    gram(s)
    /
    100.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        42
        day
      • Milk
        80
        hour
  • Subcutaneous use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CR02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Available in:
  • Ireland
Package description:
  • Noroclav Injection will be supplied in clear colourless type II glass vial of 50 ml complete with nitryl bung and aluminium cap.
  • Noroclav Injection will be supplied in clear colourless type II glass vial of 100 ml complete with nitryl bung and aluminium cap.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Informed consent (abridged application) - Council Directive 81/851/EEC
Marketing authorisation holder:
  • Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Laboratories Limited
  • Norbrook Manufacturing Limited
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA22664/058/001
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0585/001
Concerned member states:
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."