Veterinary Medicine Information website

Busol 0.004 mg/ml solution for injection for cattle, horses, rabbits

Authorised
  • Buserelin acetate
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Product identification

Medicine name:
Busol 0.004 mg/ml solution for injection for cattle, horses, rabbits
Active substance:
  • Buserelin acetate
Target species:
  • Cattle
  • Horse
  • Rabbit
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Buserelin acetate
    0.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Rabbit
      • Meat and offal
        0
        day
  • Intravenous use
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        day
  • Subcutaneous use
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Rabbit
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH01CA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Available in:
  • Belgium
Package description:
  • Pack of 5 injection vials (glass type I) each containing 10 ml in a cardboard carton.Injection vial closed with a bromobutyl rubber stopper and sealed with an aluminium crimp cap.
  • Pack of 50 (10x5) injection vials (multipack).Injection vial closed with a bromobutyl rubber stopper and sealed with an aluminium crimp cap.
  • Pack of 100 (20x5) injection vials (multipack).Injection vial closed with a bromobutyl rubber stopper and sealed with an aluminium crimp cap.
  • Pack of 250 (50x5) injection vials (multipack).Injection vial closed with a bromobutyl rubber stopper and sealed with an aluminium crimp cap.
  • Pack of 500 (100x5) injection vials (multipack).Injection vial closed with a bromobutyl rubber stopper and sealed with an aluminium crimp cap.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
  • T. P. Whelehan Son & Co. Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • aniMedica GmbH
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V525342
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0213/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Estonia
  • Finland
  • Greece
  • Hungary
  • Iceland
  • Italy
  • Latvia
  • Lithuania
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/01/2026
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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

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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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
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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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ie-puar-mr-iev0213001-busol-0004-mgml-solution-for-injection-for-cattle--en.pdf

English (PDF)
Published on: 11/01/2026
Download