Veterinary Medicines

Profexx 50 mg/ml solution for injection for cattle

Authorised
  • Carprofen
  • Carprofen
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Product identification

Medicine name:
Profexx 50 mg/ml solution for injection for cattle
Profexx 50 mg/ml Roztwór do wstrzykiwań
Active substance:
  • Carprofen
  • Carprofen
Target species:
  • Cattle
  • Cattle
Route of administration:
  • Subcutaneous use
  • Intravenous use

Product details

Active substance and strength:
  • Carprofen
    50.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Carprofen
    50.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • Meat and offal
        21
        day
      • Milk
        no withdrawal period
  • Intravenous use
    • Cattle
      • Meat and offal
        21
        day
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AE91
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:
  • Cardboard box containing one clear glass (type II) vial of 100 ml with a grey bromobutyl rubber stopper and aluminium cap
  • Cardboard box containing one clear glass (type II) vial of 250 ml with a grey bromobutyl rubber stopper and aluminium cap
  • Cardboard box containing one clear glass (type II) vial of 50 ml with a grey bromobutyl rubber stopper and aluminium cap

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Alfasan Nederland B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Alfasan Nederland B.V.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 3304
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0409/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)
Generic of:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 25/10/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 25/10/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 25/10/2024
Download
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