Veterinary Medicines

Cardisure Flavoured 1.25 mg Tablets for Dogs

Authorised
  • Pimobendan
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Product identification

Medicine name:
Cardisure Flavoured 1.25 mg Tablets for Dogs
Cardisure 1,25 mg tabletten met smaakstof voor honden
Active substance:
  • Pimobendan
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Pimobendan
    1.25
    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:
  • Netherlands
Package description:
  • 10 blisters per carton, 10 tablets per blister (Aluminium - PVC,PE,PVDC blister)
  • 10 blisters per carton, 10 tablets per blister (Aluminium - Aluminium blister)
  • 2 blisters per carton, 10 tablets per blister (Aluminium - PVC,PE,PVDC blister)
  • 2 blisters per carton, 10 tablets per blister (Aluminium - Aluminium blister)
  • 25 blisters per carton, 10 tablets per blister (Aluminium - Aluminium blister)
  • 25 blisters per carton, 10 tablets per blister (Aluminium - PVC,PE,PVDC blister)
  • 5 blisters per carton, 10 tablets per blister (Aluminium - PVC,PE,PVDC blister)
  • 5 blisters per carton, 10 tablets per blister (Aluminium - Aluminium 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:
  • Dales Pharmaceuticals Limited
  • Eurovet Animal Health B.V.
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 107727
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0280/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Ireland
  • Italy
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 19/01/2022
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Summary of Product Characteristics

English (PDF)
Published on: 16/06/2022
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107727 PAR.pdf

English (PDF)
Published on: 16/06/2022
Download
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