Veterinary Medicines

Buserelin aniMedica 0,004 mg/ml solution for injection for cattle, horses, rabbits

Authorised
  • Buserelin acetate
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Product identification

Medicine name:
Buserelin aniMedica 0,004 mg/ml solution for injection for cattle, horses, rabbits
Buserelin aniMedica 0,004 mg/ml roztwór do wstrzykiwań dla bydła, koni i królików
Active substance:
  • Buserelin acetate
Target species:
  • Cattle
  • Horse
  • Rabbit
Route of administration:
  • Intramuscular use
  • Subcutaneous use
  • Intravenous 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
      • Milk
        0
        day
      • Meat and offal
        0
        day
    • Rabbit
      • Meat and offal
        0
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Horse
      • Milk
        0
        day
      • Meat and offal
        0
        day
    • Rabbit
      • Meat and offal
        0
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Horse
      • Milk
        0
        day
      • Meat and offal
        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:
  • Poland
Package description:
  • (ID14) 50 millilitre(s): unspecified outer container with 5 Vial (glass) each with 10 millilitre(s)
  • (ID4) 5000 millilitre(s): unspecified outer container with 100 unspecified outer container each with 5 Vial (glass) each with 10 millilitre(s)
  • (ID3) 2500 millilitre(s): unspecified outer container with 50 unspecified outer container each with 5 Vial (glass) each with 10 millilitre(s)
  • (ID2) 1000 millilitre(s): unspecified outer container with 20 unspecified outer container each with 5 Vial (glass) each with 10 millilitre(s)
  • (ID1) 500 millilitre(s): unspecified outer container with 10 unspecified outer container each with 5 Vial (glass) each with 10 millilitre(s)

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:
  • aniMedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • aniMedica GmbH
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 1665
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0110/001
Concerned member states:
  • Austria
  • France
  • Poland
  • United Kingdom (Northern Ireland)

Documents

Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 27/01/2025
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Combined File of all Documents

English (PDF)
Published on: 4/12/2025
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