Veterinary Medicines

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
Butasal-100 100 mg/ml + 0,05 mg/ml solução injetável para cavalos, bovinos e cães
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
    • Dog
  • Intramuscular use
    • Dog
  • Subcutaneous use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA12CX99
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Portugal
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:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 1446/01/21RFVPT
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

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Portuguese (PDF)
Published on: 21/03/2025
Download

Summary of Product Characteristics

English (PDF)
Published on: 13/02/2025
Download

eu-puar-eev0106001-mr-butasal-100-en.pdf

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