Fatrobendan 10 mg, chewable tablets for dogs
Fatrobendan 10 mg, chewable tablets for dogs
Authorised
- Pimobendan
Product identification
Medicine name:
Fatrobendan 10 mg, chewable tablets for dogs
Fatrobendan 10 mg, chewable tablets for dogs
Active substance:
- Pimobendan
Target species:
-
Dog
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Pimobendan10.00/milligram(s)1.00Tablet
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:
-
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
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:
- Health Products Regulatory Authority
Authorisation number:
- VPA10836/011/003
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0571/003
Concerned member states:
-
Cyprus
-
Czechia
-
Greece
-
Lithuania
-
Poland
-
Portugal
-
Slovakia
-
Spain
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
