Veterinary Medicines

GESTAVET HCG 200 / PMSG 400

Authorised
  • Gonadotropin, equine, serum
  • HUMAN CHORIONIC GONADOTROPIN
Download as PDF

Product identification

Medicine name:
GESTAVET HCG 200 / PMSG 400
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:
  • Malta
Package description:
  • box containing 10 vials of lyophilisate and box containing 10 vials of 5 ml of solvent
  • box containing 5 vials of lyophilisate and 5 vials of 5 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:
  • Laboratorios Hipra S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Hipra S.A.
Responsible authority:
  • Ministry For Agriculture, Fisheries And Animal Rights
Authorisation number:
  • VMA22
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
Download

Package Leaflet

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

Labelling

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

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

English (PDF)
Published on: 2/02/2024
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."