Veterinary Medicines

Folligon PMSG 200 IU/ml lyophilisate and solvent for solution for injection

Authorised
  • Gonadotropin, equine, serum
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Product identification

Medicine name:
Folligon PMSG 200 IU/ml lyophilisate and solvent for solution for injection
Active substance:
  • Gonadotropin, equine, serum
Target species:
  • Cattle
  • Sheep
  • Pig
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Gonadotropin, equine, serum
    5000.00
    international unit(s)
    /
    1.00
    Vial
Pharmaceutical form:
  • Lyophilisate and solvent for solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Pig
      • Meat and offal
        0
        day
  • Subcutaneous use
    • Pig
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG03GA03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Package description:
  • Lyophilisate: Clear, type I (Ph. Eur.) glass vials with halogenobutyl rubber stopper, closed with a colour codedaluminium cap.Solvent: Clear, type I (Ph. Eur) or type II (Ph. Eur.) glass vials with halogenobutyl rubber stopper, closed with a colourcoded aluminium cap.Pack sizes:Cardboard box with 1 vial of 1,000 IU lyophilisate and 1 x 5 ml vial of solvent.
  • Lyophilisate: Clear, type I (Ph. Eur.) glass vials with halogenobutyl rubber stopper, closed with a colour codedaluminium cap.Solvent: Clear, type I (Ph. Eur) or type II (Ph. Eur.) glass vials with halogenobutyl rubber stopper, closed with a colourcoded aluminium cap.Pack sizes:Cardboard box with 1 vial of 5,000 IU lyophilisate and 1 x 25 ml vial of solvent.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Intervet (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Intervet International GmbH
  • Intervet International B.V.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10996/055/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 24/11/2024
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