Veterinary Medicines

GESTAVET HCG 1000 / PMSG 2000

Authorised
  • HUMAN CHORIONIC GONADOTROPIN
  • Gonadotropin, equine, serum
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Product identification

Medicine name:
GESTAVET HCG 1000 / PMSG 2000
Gestavet 3000 Lyofilisaat voor oplossing voor injectie
Gestavet 3000 Lyophilisat pour solution injectable
Gestavet 3000 Lyophilisat zur Herstellung einer Injektionslösung
Active substance:
  • HUMAN CHORIONIC GONADOTROPIN
  • Gonadotropin, equine, serum
Target species:
  • Pig (sow)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • HUMAN CHORIONIC GONADOTROPIN
    1000.00
    international unit(s)
    /
    1.00
    Vial
  • Gonadotropin, equine, serum
    2000.00
    international unit(s)
    /
    1.00
    Vial
Pharmaceutical form:
  • Lyophilisate and solvent for solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig (sow)
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG03GA99
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • box containing 10 vials of lyophilisate and box containing 10 vials containing 25 ml of solvent

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:
  • Biogenesis Global S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Hipra S.A.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V351407
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0134/002
Concerned member states:
  • Austria
  • Belgium
  • France
  • Germany
  • Greece
  • Italy
  • Lithuania
  • Malta
  • Netherlands
  • Portugal
  • United Kingdom (Northern Ireland)

Documents

Package Leaflet

English (PDF)
Published on: 2/02/2024
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Dutch (PDF)
Published on: 22/03/2022
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French (PDF)
Published on: 22/03/2022
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German (PDF)
Published on: 22/03/2022
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Summary of Product Characteristics

English (PDF)
Published on: 2/02/2024
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Dutch (PDF)
Published on: 22/03/2022
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French (PDF)
Published on: 22/03/2022
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Labelling

English (PDF)
Published on: 2/02/2024
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eu-PUAR-esv0134002-mrp-gestavet-hcg-1000---pmsg-2000-en.pdf

English (PDF)
Published on: 2/02/2024
Download
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