Veterinary Medicines

GESTAVET HCG 200 / PMSG 400

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

Medicine name:
GESTAVET HCG 200 / PMSG 400
GESTAVET HCG 200/PMSG 400 LIOFILIZADO Y DISOLVENTE PARA SOLUCION INYECTABLE PARA PORCINO
Active substance:
  • Gonadotropin, equine, serum
  • HUMAN CHORIONIC GONADOTROPIN
Target species:
  • Pig (sow)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Gonadotropin, equine, serum
    400.00
    international unit(s)
    /
    5.00
    millilitre(s)
  • HUMAN CHORIONIC GONADOTROPIN
    200.00
    international unit(s)
    /
    5.00
    millilitre(s)
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:
  • Spain
Package description:

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:
  • The Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 1355 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0134/001
Concerned member states:
  • Austria
  • Belgium
  • France
  • Germany
  • Greece
  • Italy
  • Lithuania
  • Malta
  • Netherlands
  • Portugal
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

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

Package Leaflet

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

Labelling

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

Combined File of all Documents

English (PDF)
Published on: 21/11/2022
Download

eu-PUAR-esv0134001-mrp-gestavet-hcg-200---pmsg-400-en.pdf

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

es-puar-gestavet-hcg-200---pmsg-400-es.pdf

Spanish (PDF)
Published on: 17/03/2023
Download
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