Veterinary Medicines

Fixplan 200 IU/ml lyophilisate and solvent for solution for injection

Authorised
  • Gonadotropin, equine, serum
  • Water for injection
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Product identification

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

Product details

Active substance and strength:
  • Gonadotropin, equine, serum
    200.00
    international unit(s)
    /
    1.00
    millilitre(s)
  • Water for injection
    1.00
    other
    /
    1.00
    millilitre(s)
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
        hour
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • 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
Available in:
  • Ireland
Package description:
  • Lyophilisate: 8 ml colourless type I glass vial closed with a grey bromobutyl rubber stopper, aluminium seals and prolypropylene caps. Solvent: 30 ml colourless type II glass vial closed with a grey bromobutyl rubber stopper, aluminium seals and polypropylene caps. Carton box containing 1 vial of 5,000 IU lyophilisate and 1 vial of solvent (25 ml).

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:
  • Syn Vet-Pharma Ireland Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • V.M.D.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA23174/002/001
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0448/001
Concerned member states:
  • Belgium
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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