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 vet. 1,25 mg tabletter til hund
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:
  • Norway
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:
  • Eurovet Animal Health B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Dales Pharmaceuticals Limited
  • Eurovet Animal Health B.V.
Responsible authority:
  • Norwegian Medical Products Agency
Authorisation number:
  • 10-7667
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

Summary of Product Characteristics

English (PDF)
Published on: 16/06/2022
Download
Norwegian (PDF)
Published on: 14/01/2022
Download

107727 PAR.pdf

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