Veterinary Medicines

VETERELIN 0.004 mg/ml solution for injection for cattle, horses, pigs, and rabbits

Authorised
  • Buserelin
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Product identification

Medicine name:
VETERELIN 0.004 mg/ml solution for injection for cattle, horses, pigs, and rabbits
Veterelin 0.004 mg/ml Oplossing voor injectie
Veterelin 0.004 mg/ml Solution injectable
Veterelin 0.004 mg/ml Injektionslösung
Active substance:
  • Buserelin
Target species:
  • Cattle
  • Horse
  • Rabbit
  • Pig
Route of administration:
  • Intramuscular use
  • Subcutaneous use
  • Intravenous use

Product details

Active substance and strength:
  • Buserelin
    0.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Milk
        0
        day
      • Meat and offal
        0
        day
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Rabbit
      • Meat and offal
        0
        day
    • Pig
      • Meat and offal
        0
        day
  • Subcutaneous use
    • Cattle
      • Milk
        0
        day
      • Meat
        0
        day
    • Horse
      • Milk
        0
        day
      • Meat
        0
        day
    • Rabbit
      • Meat
        0
        day
  • Intravenous use
    • Cattle
      • Meat
        0
        day
      • Milk
        0
        day
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Rabbit
      • Meat and offal
        0
        day
    • Pig
      • 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:
  • Colourless glass vials of 10 ml, with bromobutyl rubber closure and aluminium capsules with Flip-off opening ring in PP of blue colour. 5 Bottles of 10 ml.
  • Colourless glass vials of 20 ml, with bromobutyl rubber closure and aluminium capsules with Flip-off opening ring in PP of blue colour. 1 Bottle of 20 ml.
  • Colourless glass vials of 10 ml, with bromobutyl rubber closure and aluminium capsules with Flip-off opening ring in PP of blue colour. 1 Bottle of 10 ml.
  • Colourless glass vials of 10 ml, with bromobutyl rubber closure and aluminium capsules with Flip-off opening ring in PP of blue colour. 1 Bottles of 100 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:
  • Laboratorios Calier S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Calier S.A.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V395577
Date of authorisation status change:
Reference member state:
  • Portugal
Procedure number:
  • PT/V/0104/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Romania
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 17/11/2021
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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.
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

This document does not exist in this language (English). You can find it in another language below.
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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Combined File of all Documents

English (PDF)
Published on: 1/08/2025
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