Veterinary Medicines

BUSCOPAN COMPOSITUM ad us. vet. 4 mg/ml + 500 mg/ml, oplossing voor injectie voor paarden, kalveren en honden

Authorised
  • Metamizole sodium
  • Hyoscine butylbromide
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Product identification

Medicine name:
BUSCOPAN COMPOSITUM ad us. vet. 4 mg/ml + 500 mg/ml, oplossing voor injectie voor paarden, kalveren en honden
BUSCOPAN COMPOSITUM ad us.vet. 4 mg/ml + 500 mg/ml, solution injectable pour chevaux, veaux et chiens
Buscopan Compositum ad us. vet. 4 mg/ml + 500 mg/ml, Injektionslösung für Pferde, Kälber und Hunde
Active substance:
  • Metamizole sodium
  • Hyoscine butylbromide
Target species:
  • Horse
  • Dog
  • Cattle
  • Cattle (calf)
Route of administration:
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Metamizole sodium
    500.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Hyoscine butylbromide
    4.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Horse
      • Meat and offal
        12
        day
      • Milk
        no withdrawal period
    • Cattle
      • Milk
        no withdrawal period
    • Cattle (calf)
      • Meat and offal
        15
        day
  • Subcutaneous use
    • Horse
      • Meat and offal
        12
        day
      • Milk
        no withdrawal period
    • Cattle
      • Milk
        no withdrawal period
    • Cattle (calf)
      • Meat and offal
        15
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA03BB01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Available in:
  • Belgium
Package description:
  • Buscopan Compositum ad us. vet 1 Vial of 100 ml with Solution for injection

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Boehringer Ingelheim Vetmedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Labiana Life Sciences S.A.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V158261
Date of authorisation status change:

Documents

Summary of Product Characteristics

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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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Package Leaflet

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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

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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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