Butafosal 100 mg/ml + 0.05 mg/ml solution for injection for cattle, horses and dogs
Butafosal 100 mg/ml + 0.05 mg/ml solution for injection for cattle, horses and dogs
Authorised
- Butafosfan
- Cyanocobalamin
Product identification
Medicine name:
Butafosal 100 mg/ml + 0.05 mg/ml solution for injection for cattle, horses and dogs
Butafosal 100 mg/ml + 0,05 mg/ml solution injectable pour bovins, chevaux et chiens
Butafosal 100 mg/ml + 0,05 mg/ml oplossing voor injectie voor runderen, paarden en honden
Butafosal 100 mg/ml + 0,05 mg/ml Injektionslösung für Rinder, Pferde und Hunde
Active substance:
- Butafosfan
- Cyanocobalamin
Target species:
-
Dog
-
Cattle
-
Horse
Route of administration:
-
Intravenous use
-
Intramuscular use
-
Subcutaneous use
Product details
Active substance and strength:
-
Butafosfan100.00/milligram(s)1.00millilitre(s)
-
Cyanocobalamin0.05/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intravenous use
-
Cattle
-
Meat and offal, milk0day
-
-
Horse
-
Meat and offal, milk0day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QA12CX99
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- Cardboard box containing 1 vial of 50 ml solution for injection. Amber glass vials of glass type II with bromobutyl rubber stopper and aluminum overseal in a cardboard box.
- Cardboard box containing 1 vial of 100 ml solution for injection. Amber glass vials of glass type II with bromobutyl rubber stopper and aluminum overseal in a cardboard box.
- Cardboard box containing 1 vial of 250 ml solution for injection. Amber glass vials of glass type II with bromobutyl rubber stopper and aluminum overseal in a cardboard box.
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
- Alivira Animal Health Limited
Marketing authorisation date:
Manufacturing sites for batch release:
- Laboratorios Karizoo S.A.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V664787
Date of authorisation status change:
Reference member state:
-
Netherlands
Procedure number:
- NL/V/0418/001
Concerned member states:
-
Belgium
-
France
-
Germany
-
Italy
-
Spain
Generic of:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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in another language below.
Labelling
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Package Leaflet
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in another language below.
NLV0418001DC- Butafosal PuAR final.pdf
English (PDF)
Download Published on: 26/01/2026
