Veterinary Medicines

ZELYS 1,25 MG CHEWABLE TABLETS FOR DOGS

Authorised
  • Pimobendan
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Product identification

Medicine name:
ZELYS 1,25 MG CHEWABLE TABLETS FOR DOGS
Zelys 1,25 mg tyggetabletter
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:
  • Chewable 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:
  • Box containing 1 vial of 60 tablets
  • Box containing 8 blisters of 12 tablets
  • Box containing 3 blisters of 12 tablets

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Ceva Sante Animale
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 58620
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0356/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 31/07/2023
Updated on: 1/08/2023
Download
Danish (PDF)
Published on: 4/09/2024
Download

Package Leaflet

English (PDF)
Published on: 31/07/2023
Updated on: 1/08/2023
Download
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