Authorised

Product identification

Medicine name:
Addimag 240 mg/ml + 126 mg/ml Solution pour perfusion
Addimag 240 mg/ml + 126 mg/ml Oplossing voor infusie
Addimag 240 mg/ml + 126 mg/ml Infusionslösung
Addimag 240 mg/ml + 126 mg/ml solution for infusion for cattle
Active substance:
  • Calcium gluconate monohydrate
  • Magnesium chloride hexahydrate
Target species:
  • Cattle
Route of administration:
  • Solution for infusion

Product details

Active substance and strength:
  • Calcium gluconate monohydrate
    240.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Magnesium chloride hexahydrate
    126.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Concentrate for solution for infusion
Withdrawal period by route of administration:
  • Solution for infusion
    • Cattle
      • Meat and offal
        no withdrawal period
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA12AX
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • 750 ml square shaped clear polypropylene (PP) bottle with a bromobutyl rubber stopper and an aluminium screw cap.
  • 500 ml square shaped clear polypropylene (PP) bottle with a bromobutyl rubber stopper and an aluminium screw cap

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Alfasan Nederland B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Alfasan Nederland B.V.
  • Bela-Pharm GmbH & Co. KG
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V660952
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0352/002/DC
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)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 6/02/2023
Download
French (PDF)
Published on: 6/02/2023
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 6/02/2023
Download
French (PDF)
Published on: 6/02/2023
Download
German (PDF)
Published on: 6/02/2023
Download

Combined File of all Documents

English (PDF)
Published on: 25/04/2022
Download
Source URL: https://medicines.health.europa.eu/veterinary/600000091895