Veterinary Medicines

Fertigest 0.004 mg/ml solution for injection

Authorised
  • Buserelin
Download as PDF

Product identification

Medicine name:
Fertigest 0.004 mg/ml solution for injection
Fertigest 0.004 mg/ml Oplossing voor injectie
Fertigest 0.004 mg/ml Solution injectable
Fertigest 0.004 mg/ml Injektionslösung
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
        0
        day
      • Meat and offal
        0
        day
    • Horse
      • Milk
        0
        day
      • Meat and offal
        0
        day
    • Rabbit
      • Meat and offal
        0
        day
    • Pig
      • Meat and offal
        0
        day
  • Subcutaneous use
    • Cattle (cow)
      • Milk
        0
        day
      • Meat and offal
        0
        day
    • Horse
      • Milk
        0
        day
      • Meat and offal
        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:
  • 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.U.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V520035
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

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 7/03/2023
Download
French (PDF)
Published on: 7/03/2023
Download
German (PDF)
Published on: 7/03/2023
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 7/03/2023
Download
French (PDF)
Published on: 7/03/2023
Download
German (PDF)
Published on: 7/03/2023
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."