Veterinary Medicines

Cardisure 3.5 mg/ml Oral Solution for Dogs

Authorised
  • Pimobendan
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Product identification

Medicine name:
Cardisure 3.5 mg/ml Oral Solution for Dogs
Cardisure 3,5 mg/ml Lösung zum Eingeben für Hunde
Active substance:
  • Pimobendan
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Pimobendan
    3.50
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral solution
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QC01CE90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Austria
Package description:
  • Brown high-density polyethylene bottles fitted with white polypropylene child resistant caps, and low-density polyethylenesyringe adaptors.A low-density polyethylene oral dosing syringe with graduations is supplied with the product.Pack size:Carton box containing 1 bottle of 168 ml and a 3 ml dosing syringe
  • Brown high-density polyethylene bottles fitted with white polypropylene child resistant caps, and low-density polyethylenesyringe adaptors.A low-density polyethylene oral dosing syringe with graduations is supplied with the product.Pack size:Carton box containing 1 bottle of 42 ml and a 1.5 ml dosing syringe

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:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • GENERA d.d.
Responsible authority:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 839151
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0421/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Greece
  • Hungary
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Sweden

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 17/03/2022
Updated on: 30/08/2024
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Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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German (PDF)
Published on: 19/01/2022
Updated on: 30/08/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 19/01/2022
Updated on: 30/08/2024
Download
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