Veterinary Medicines

Salmoporc, lyophilisate for oral suspension for pigs

Authorised
  • Salmonella enterica, subsp. enterica, serovar Typhimurium, strain 421/125 (histidine-adenine auxotrohic), Live
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Product identification

Medicine name:
Salmoporc, lyophilisate for oral suspension for pigs
SALMOPORC, liofilizat pentru suspensie orală pentru porcine
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:
  • Romania
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 Sante Animale Romania S.R.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva-Phylaxia Zrt.
  • IDT Biologika GmbH
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 240044
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

Summary of Product Characteristics

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Romanian (PDF)
Published on: 2/04/2024
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