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 kauwtabletten 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:
  • 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:
  • Netherlands
Package description:
  • Box containing 3 blisters of 12 tablets
  • Box containing 8 blisters of 12 tablets
  • Box containing 1 vial of 60 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 B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 120129
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

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: 26/04/2022
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Summary of Product Characteristics

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

Package Leaflet

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