Veterinary Medicines

Norocarp 50 mg/ml Solution for Injection for Cattle

Authorised
  • Carprofen
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Product identification

Medicine name:
Norocarp 50 mg/ml Solution for Injection for Cattle
Norocarp 50 mg/ml Oplossing voor injectie
Norocarp 50 mg/ml Solution injectable
Norocarp 50 mg/ml Injektionslösung
Active substance:
  • Carprofen
Target species:
  • Cattle
Route of administration:
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Carprofen
    50.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Cattle
      • Meat and offal
        21
        day
      • Milk
        0
        hour
  • Subcutaneous use
    • Cattle
      • Meat and offal
        21
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AE91
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • Norocarp Injection for Cattle in 1 x 50ml multidose amber glass (Type I) vial, sealed with 20mm bromobutyl bung and 20mm aluminium seal.
  • Norocarp Injection for Cattle in 5 x 50ml multidose amber glass (Type I) vials, sealed with 20mm bromobutyl bungs and 20mm aluminium seals.
  • Norocarp Injection for Cattle in 6 x 50ml multidose amber glass (Type I) vials, sealed with 20mm bromobutyl bungs and 20mm aluminium seals.
  • Norocarp Injection for Cattle in 10 x 50ml multidose amber glass (Type I) vials, sealed with 20mm bromobutyl bungs and 20mm aluminium seals.
  • Norocarp Injection for Cattle in 12 x 50ml multidose amber glass (Type I) vials, sealed with 20mm bromobutyl bungs and 20mm aluminium seals.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a 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:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V346674
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0230/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Finland
  • France
  • Germany
  • Italy
  • Norway
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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Dutch (PDF)
Published on: 22/03/2022
Download
French (PDF)
Published on: 22/03/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/03/2022
Download
French (PDF)
Published on: 22/03/2022
Download
German (PDF)
Published on: 22/03/2022
Download
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