File downloaded on 2026-01-11
Source URL: https://medicines.health.europa.eu/veterinary/en/600000032859
Authorised

Product identification

Medicine name:
Salmoporc, liofilizado para suspensão oral para suínos
Salmoporc, lyophilisate for oral suspension for pigs
Active substance:
  • Salmonella enterica, subsp. enterica, serovar Typhimurium, strain 421/125 (histidine-adenine auxotrohic), Live
Target species:
  • Pig
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Salmonella enterica, subsp. enterica, serovar Typhimurium, strain 421/125 (histidine-adenine auxotrohic), Live
    8.00
    log10 colony forming unit(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral lyophilisate
Withdrawal period by route of administration:
  • Oral 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:
  • Portugal
Package description:
  • Cardboard box containing one 10 ml glass vial (type I) with rubber stoppers and aluminium crimp caps containing 200 doses (1 dose = 1 ml) of lyophilisate.

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 Saude Animal Produtos Farmaceuticos E Imunologicos Lda.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva-Phylaxia Zrt.
  • IDT Biologika GmbH
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 966/02/19DIVPT
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0247/002
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Hungary
  • Ireland
  • Italy
  • Portugal
  • Romania
  • Slovakia
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Portuguese (PDF)
Published on: 4/11/2022
Download