Authorised

Product identification

Medicine name:
Salmoporc, lyophilisate and solvent for suspension for injection for pigs
Salmoporc Lyophilisat und Lösungsmittel zur Herstellung einer Injektionssuspension für Schweine
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:
  • Austria
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 Zrt.
  • IDT Biologika GmbH
Responsible authority:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 838869
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

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 5/01/2021
Updated on: 25/09/2024
Download

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 10/04/2019
Updated on: 25/09/2024
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 15/09/2020
Updated on: 25/09/2024
Download
Source URL: https://medicines.health.europa.eu/veterinary/600000033165