Veterinary Medicines

Cardisan 15 mg chewable tablets for dogs

Authorised
  • Pimobendan
Download as PDF

Product identification

Medicine name:
Cardisan 15 mg chewable tablets for dogs
Cardisan 15 mg žvečljive tablete za pse
Active substance:
  • Pimobendan
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Pimobendan
    15.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Chewable tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
      • All relevant tissues
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QC01CE90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovenia
Package description:
  • Cardbox containing 24 Aluminium-OPA/Aluminium/PVC blisters containing 5 tablets each.
  • Cardbox containing 20 Aluminium-OPA/Aluminium/PVC blisters containing 5 tablets each.
  • Cardbox containing 18 Aluminium-OPA/Aluminium/PVC blisters containing 5 tablets each.
  • Cardbox containing 12 Aluminium-OPA/Aluminium/PVC blisters containing 5 tablets each.
  • Cardbox containing 6 Aluminium-OPA/Aluminium/PVC blisters containing 5 tablets each.

Additional information

Entitlement type:
  • Marketing Authorisation
Marketing authorisation holder:
  • Alfasan Nederland B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Alfasan Nederland B.V.
  • Lelypharma B.V.
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • DC/V/0761/005
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0380/005
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • 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.
Slovenian (PDF)
Published on: 24/07/2024
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 24/07/2024
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 24/07/2024
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."