Veterinary Medicines

Fatrobendan 1.25 mg, chewable tablets for dogs

Authorised
  • Pimobendan
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Product identification

Medicine name:
Fatrobendan 1.25 mg, chewable tablets for dogs
Fatrobendan 1,25 mg Tabletka do rozgryzania i żucia
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
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QC01CE90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:
  • 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)
  • 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)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Fatro S.p.A.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 3358
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0571/001
Concerned member states:
  • Cyprus
  • Czechia
  • Greece
  • Lithuania
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • United Kingdom (Northern Ireland)