Veterinary Medicines

ZELYS 10 MG CHEWABLE TABLETS FOR DOGS

Authorised
  • Pimobendan
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Product identification

Medicine name:
ZELYS 10 MG CHEWABLE TABLETS FOR DOGS
ZELYS 10 mg comprimate masticabile pentru câini
Active substance:
  • Pimobendan
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Pimobendan
    10.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Chewable tablet
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:

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 Romania S.R.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 230047
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0356/003
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

English (PDF)
Published on: 11/12/2024
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Romanian (PDF)
Published on: 19/09/2024
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