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 Vet. 500+500 IE pulver og solvens til injektionsvæske, opløsning
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:
  • Denmark
Available in:
  • Denmark
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:
  • Danish Medicines Agency
Authorisation number:
  • 42390
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

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Danish (, PULVER OG SOLVENS TIL INJEKTIONSVÆSKE, OPLØSNING 500+500 IE)
Published on: 4/05/2022
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