Authorised

Product identification

Medicine name:
FATROBENDAN 10 mg, chewable tablets for dogs
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
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QC01CE90
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Available in:
  • Ireland
Package description:
  • PVC/PE/PVdC/PE/PVC blister sealed with thermoheated aluminium foil containing 10 tablets.Pack-sizes:- Cardboard box containing 10 blisters of 10 tablets (100 tablets)
  • PVC/PE/PVdC/PE/PVC blister sealed with thermoheated aluminium foil containing 10 tablets.Pack-sizes:- Cardboard box containing 5 blisters of 10 tablets (50 tablets)
  • PVC/PE/PVdC/PE/PVC blister sealed with thermoheated aluminium foil containing 10 tablets.Pack-sizes:- Cardboard box containing 1 blister of 10 tablets (10 tablets)

Additional information

Entitlement type:
  • Marketing Authorisation
Marketing authorisation holder:
  • Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Fatro S.p.A.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10836/011/003
Date of authorisation status change:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 8/04/2022
Download

Source URL: https://medicines.health.europa.eu/veterinary/600000064590