Veterinary Medicines

Cardisure Flavoured 5 mg Tablets for Dogs

Authorised
  • Pimobendan
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Product identification

Medicine name:
Cardisure Flavoured 5 mg Tablets for Dogs
Cardisure Flavoured Vet. 5 mg tabletter
Active substance:
  • Pimobendan
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Pimobendan
    5.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
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:
  • Denmark
Package description:
  • 20 blisters per carton, 5 tablets per blister (Aluminium - Aluminium blister)
  • 4 blisters per carton, 5 tablets per blister (Aluminium - Aluminium blister)
  • 25 blisters per carton, 10 tablets per blister (Aluminium - PVC,PE,PVDC blister)
  • 2 blisters per carton, 10 tablets per blister (Aluminium - PVC,PE,PVDC blister)
  • 10 blisters per carton, 5 tablets per blister (Aluminium - Aluminium blister)
  • 10 blisters per carton, 10 tablets per blister (Aluminium - PVC,PE,PVDC blister)
  • 50 blisters per carton, 5 tablets per blister (Aluminium - Aluminium blister)
  • 5 blisters per carton, 10 tablets per blister (Aluminium - PVC,PE,PVDC blister)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Eurovet Animal Health B.V.
  • Genera d.d.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 47110
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0280/003
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Ireland
  • Italy
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • 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.
Danish (, TABLETTER 1,25 MG, 2,5 MG, 5 MG OG 10 MG)
Published on: 29/06/2023
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Combined File of all Documents

English (PDF)
Published on: 20/06/2022
Updated on: 21/06/2022
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107729 par.pdf

English (PDF)
Published on: 20/06/2022
Updated on: 21/06/2022
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