Veterinary Medicines

PLUSET 500 IU/500 IU powder and solvent for solution for injection for cattle

Authorised
  • FOLLICLE-STIMULATING HORMONE
  • Luteinising hormone
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Product identification

Medicine name:
PLUSET 500 IU/500 IU powder and solvent for solution for injection for cattle
PLUSET Polvere e solvente per soluzione iniettabile per bovini
Active substance:
  • FOLLICLE-STIMULATING HORMONE
  • Luteinising hormone
Target species:
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • FOLLICLE-STIMULATING HORMONE
    500.00
    international unit(s)
    /
    10.00
    millilitre(s)
  • Luteinising hormone
    500.00
    international unit(s)
    /
    10.00
    millilitre(s)
Pharmaceutical form:
  • Powder and solvent for solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG03GA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Available in:
  • Italy
Package description:
  • Cardboard box with 2 glass vials of 10 ml of lyophilised product and 1 glass vial of 21 ml of diluent. Lyophilised product: Vial of colourless neutral glass (type 1) Capacity: 10 ml. Provided with bromobutyl and silicate stopper and aluminium cap flip off seal. Container for the diluent: Vial of colourless neutral glass (type 1) Capacity: 21 ml. With rubber penitype stopper of grey colour and aluminium cap flip off seal.

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 Calier S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Calier S.A.
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 101400
Date of authorisation status change:
Reference member state:
  • Italy
Procedure number:
  • IT/V/0117/001
Concerned member states:
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 3/01/2022
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Italian (PDF)
Published on: 6/02/2022
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