Veterinary Medicine Information website

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

Authorised
  • Cyanocobalamin
  • Butafosfan
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Product identification

Medicine name:
Butasal-100, 100 mg/ml + 0.05 mg/ml solution for injection for horses, cattle and dogs
Active substance:
  • Cyanocobalamin
  • Butafosfan
Target species:
  • Cattle
  • Horse
  • Dog
Route of administration:
  • Intravenous use
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Cyanocobalamin
    0.05
    milligram(s)
    /
    1.00
    millilitre(s)
  • Butafosfan
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        hour
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:
  • Amber glass vial, closed with a bromobutyl rubber stopper and secured with an aluminium cap or flipoff cap with polypropylene cover. Package size: Cardboard box of 6 carton boxes of 1 vial of 100 mL
  • Amber glass vial, closed with a bromobutyl rubber stopper and secured with an aluminium cap or flipoff cap with polypropylene cover. Package size: Cardboard box of 1 vial of 100 mL.
  • Amber glass vial, closed with a bromobutyl rubber stopper and secured with an aluminium cap or flip-off cap with polypropylene cover. Cardboard box of 6 carton boxes of 1 vial of 50 mL.
  • Amber glass vial, closed with a bromobutyl rubber stopper and secured with an aluminium cap or flip-off cap with polypropylene cover. Cardboard boxes of 1 vial of 50 mL.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Interchemie Werken De Adelaar Eesti AS
Marketing authorisation date:
Manufacturing sites for batch release:
  • Interchemie Werken De Adelaar Eesti AS
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V587537
Date of authorisation status change:
Reference member state:
  • Estonia
Procedure number:
  • EE/V/0106/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Finland
  • France
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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Dutch (PDF)
Published on: 18/08/2025
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Summary of Product Characteristics

English (PDF)
Published on: 13/02/2025
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Dutch (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 18/08/2025
Download
German (PDF)
Published on: 18/08/2025
Download
Dutch (PDF)
Published on: 18/08/2025
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eu-puar-eev0106001-mr-butasal-100-en.pdf

English (PDF)
Published on: 5/03/2025
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