Veterinary Medicines

Butafosal 100 mg/ml + 0.05 mg/ml solution for injection for cattle, horses and dogs

Authorised
  • Butafosfan
  • Cyanocobalamin
Download as PDF

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 oplossing voor injectie voor runderen, paarden en honden
Active substance:
  • Butafosfan
  • Cyanocobalamin
Target species:
  • Dog
  • Cattle
  • Horse
Route of administration:
  • Intravenous use
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Butafosfan
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Cyanocobalamin
    0.05
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Cattle
      • Meat and offal, milk
        0
        day
    • Horse
      • Meat and offal, milk
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA12CX99
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
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:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 133418
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:

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 16/10/2025
Download

NLV0418001DC- Butafosal PuAR final.pdf

English (PDF)
Published on: 26/01/2026
Download