Veterinary Medicines

GESLIN

Authorised
  • Buserelin acetate
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Product identification

Medicine name:
GESLIN
GESLIN 0,0040 mg/ml soluție injectabilă pentru bovine, cal, porc și iepure
Active substance:
  • Buserelin acetate
Target species:
  • Cattle (cow)
  • Pig (sow for reproduction)
  • Horse (mare)
  • Rabbit (female for reproduction)
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 (cow)
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Pig (sow for reproduction)
      • Meat and offal
        0
        day
    • Horse (mare)
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Rabbit (female for reproduction)
      • Meat and offal
        0
        day
  • Intravenous use
    • Cattle (cow)
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Pig (sow for reproduction)
      • Meat and offal
        0
        day
    • Horse (mare)
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Rabbit (female for reproduction)
      • Meat and offal
        0
        day
  • Subcutaneous use
    • Cattle (cow)
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Pig (sow for reproduction)
      • Meat and offal
        0
        day
    • Horse (mare)
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Rabbit (female for reproduction)
      • 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:
  • Romania
Available in:
  • Romania
Package description:
  • Box with 1 vial of 20 ml
  • Box with 5 vials of 20 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:
  • Mevet S.A.U.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Mevet S.A.U.
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 240009
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0434/001
Concerned member states:
  • Cyprus
  • Estonia
  • Poland
  • Romania

Documents

Combined File of all Documents

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Romanian (PDF)
Published on: 9/02/2024
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