Veterinary Medicines

Salmoporc, lyophilisate and solvent for suspension for injection for pigs

Authorised
  • Salmonella enterica, subsp. enterica, serovar Typhimurium, Live
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Product identification

Medicine name:
Salmoporc, lyophilisate and solvent for suspension for injection for pigs
Salmoporc Lyofilisaat en oplosmiddel voor suspensie voor injectie
Salmoporc Lyophilisat et solvant pour suspension injectable
Salmoporc Lyophilisat und Lösungsmittel zur Herstellung einer Injektionssuspension
Active substance:
  • Salmonella enterica, subsp. enterica, serovar Typhimurium, Live
Target species:
  • Pig
Route of administration:
  • Oral use
  • Subcutaneous use

Product details

Active substance and strength:
  • Salmonella enterica, subsp. enterica, serovar Typhimurium, Live
    8.00
    log10 colony forming unit(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Lyophilisate for suspension for injection
Withdrawal period by route of administration:
  • Oral use
    • Pig
      • Meat and offal
        6
        week
  • Subcutaneous use
    • Pig
      • Meat and offal
        6
        week
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AE02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • Cardboard box containing 1 vial with 20 doses (1 dose = 1 ml) lyophilised vaccine
  • 1 vial with 20 ml solvent

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Similar biological application (Article 13(4) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Ceva Sante Animale
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva-Phylaxia Veterinary Biologicals Co. Ltd.
  • IDT Biologika GmbH
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V541502
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0247/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Hungary
  • Ireland
  • Italy
  • Portugal
  • Romania
  • Slovakia
  • 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.
Dutch (PDF)
Published on: 20/06/2022
Updated on: 21/06/2022
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French (PDF)
Published on: 20/06/2022
Updated on: 21/06/2022
Download
German (PDF)
Published on: 20/06/2022
Updated on: 21/06/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 20/06/2022
Updated on: 21/06/2022
Download
French (PDF)
Published on: 20/06/2022
Updated on: 21/06/2022
Download
German (PDF)
Published on: 20/06/2022
Updated on: 21/06/2022
Download
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