Veterinary Medicines

Cardisan 2.5 mg chewable tablets for dogs

Authorised
  • Pimobendan
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Product identification

Medicine name:
Cardisan 2.5 mg chewable tablets for dogs
CARDISAN 2,5 mg, comprimate masticabile pentru câini
Active substance:
  • Pimobendan
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Pimobendan
    2.50
    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:
  • Romania
Package description:
  • Cardbox containing 12 Aluminium-OPA/Aluminium/PVC blisters containing 10 tablets each.
  • Cardbox containing 10 Aluminium-OPA/Aluminium/PVC blisters containing 10 tablets each.
  • Cardbox containing 9 Aluminium-OPA/Aluminium/PVC blisters containing 10 tablets each.
  • Cardbox containing 6 Aluminium-OPA/Aluminium/PVC blisters containing 10 tablets each.
  • Cardbox containing 3 Aluminium-OPA/Aluminium/PVC blisters containing 10 tablets each.

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:
  • Alfasan Nederland B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Alfasan Nederland B.V.
  • Lelypharma B.V.
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 230031
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0380/002
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

Combined File of all Documents

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Romanian (PDF)
Published on: 5/11/2025
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