Veterinary Medicines

Reproval 5% Small Animal Injection for Dogs and Cats

Authorised
  • Carprofen
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Product identification

Medicine name:
Reproval 5% Small Animal Injection for Dogs and Cats
NOROCARP 50 MG/ML SOLUZIONE INIETTABILE
Active substance:
  • Carprofen
Target species:
  • Dog
  • Cat
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
    • Dog
    • Cat
  • Subcutaneous use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AE91
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:
  • box containing 12 vials of 20 ml
  • box containing 10 vials of 20 ml
  • box containing 6 vials of 20 ml
  • box containing 5 vials of 20 ml
  • box containing 1 vial of 20 ml

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 Laboratories Limited
  • Norbrook Laboratories (Ireland) Limited
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 104118
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0345/001
Concerned member states:
  • Austria
  • Denmark
  • Finland
  • Germany
  • Italy
  • Netherlands
  • Sweden

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Italian (PDF)
Published on: 3/06/2022
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Summary of Product Characteristics

English (PDF)
Published on: 23/03/2023
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