Veterinary Medicines

BUTASYL 1 mg/ml + 50 mg/ml SOLUCION INYECTABLE

Authorised
  • Phenylbutazone
  • Sodium salicylate
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Product identification

Medicine name:
BUTASYL 1 mg/ml + 50 mg/ml SOLUCION INYECTABLE
Active substance:
  • Phenylbutazone
  • Sodium salicylate
Target species:
  • Horse (non food-producing)
Route of administration:
  • Intravenous use

Product details

Active substance and strength:
  • Phenylbutazone
    1861.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Sodium salicylate
    50.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Horse (non food-producing)
      • Meat and offal
        no withdrawal period
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01BX
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Available in:
  • Spain
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Zoetis Spain S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Manufacturing & Research Spain S.L.
Responsible authority:
  • Spanish Agency For Medicines And Medical Devices
Authorisation number:
  • 2101 ESP
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Spanish (PDF)
Published on: 13/09/2024
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Package Leaflet

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Spanish (PDF)
Published on: 23/10/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 23/10/2024
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