Veterinary Medicine Information website

Fertigest 0.004 mg/ml solution for injection

Authorised
  • Buserelin
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Product identification

Medicine name:
Fertigest 0.004 mg/ml solution for injection
Active substance:
  • Buserelin
Target species:
  • Cattle (cow)
  • Horse
  • Rabbit
  • Pig
Route of administration:
  • Intramuscular use
  • Subcutaneous 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 (cow)
      • Milk
        no withdrawal period
      • Meat and offal
        no withdrawal period
    • Horse
      • Milk
        no withdrawal period
      • Meat and offal
        no withdrawal period
    • Rabbit
      • Meat and offal
        no withdrawal period
    • Pig
      • Meat and offal
        no withdrawal period
  • Subcutaneous use
    • Cattle (cow)
      • Milk
        no withdrawal period
      • Meat and offal
        no withdrawal period
    • Horse
      • Milk
        no withdrawal period
      • Meat and offal
        no withdrawal period
    • Rabbit
      • Meat and offal
        no withdrawal period
    • Pig
      • Meat and offal
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH01CA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovakia
Package description:
  • 1 vial of 20 ml product in type I colourless glass vials closed with bromobutyl rubber stopper (type I) and sealed with aluminium cap in a cardboard box.
  • 5 vials of 20 ml product in type I colourless glass vials closed with bromobutyl rubber stopper (type I) and sealed with aluminium cap in a cardboard box.

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:
  • Vetpharma Animal Health S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Mevet S.A.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/062/DC/17-S
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0212/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Czechia
  • Germany
  • Hungary
  • Ireland
  • Poland
  • Portugal
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

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Slovak (PDF)
Published on: 25/06/2024
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