Veterinary Medicines

SALMOPORC SCS lyophilisate and solvent for suspension for pigs

Not authorised
  • Salmonella enterica, subsp. enterica, serovar Choleraesuis, strain 431/261, Live
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Product identification

Medicine name:
SALMOPORC SCS lyophilisate and solvent for suspension for pigs
Salmoporc SCS liofilizat i rozpuszczalnik do sporządzania zawiesiny dla świń
Active substance:
  • Salmonella enterica, subsp. enterica, serovar Choleraesuis, strain 431/261, Live
Target species:
  • Pig
Route of administration:
  • Subcutaneous use
  • Oral use
  • Intramuscular use

Product details

Active substance and strength:
  • Salmonella enterica, subsp. enterica, serovar Choleraesuis, strain 431/261, Live
    8273.00
    [CFU] /dose
    /
    1.00
    [CFU] /dose
Pharmaceutical form:
  • Lyophilisate and solvent for emulsion for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Pig
      • Meat and offal
        3
        week
  • Oral use
    • Pig
      • Meat and offal
        3
        week
  • Intramuscular use
    • Pig
      • Meat and offal
        3
        week
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AE02
Legal status of supply:
This information is not available for this product.
Authorisation status:
  • Revoked
Authorised in:
  • Poland
Package description:
  • Lyophilised vaccine: 10 ml hydrolytic class 1 glass bottles, each containing 50 doses of vaccine and closed with bromobutyl rubber stopper and secured caps. Solvent: 50 ml hydrolytic class 2 glass bottles, each containing 50 ml of solvent, closed with bromobutyl rubber stopper and secured caps. Cardboard carton containing 50 doses (lyophilisate and solvent).
  • Lyophilised vaccine: 10 ml hydrolytic class 1 glass bottles, each containing 10 doses of vaccine and closed with bromobutyl rubber stopper and secured caps. Solvent: 10 ml hydrolytic class 2 glass bottles, each containing 10 ml of solvent, closed with bromobutyl rubber stopper and secured caps. Cardboard carton containing 10 doses (lyophilisate and solvent).

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Ceva Animal Health Polska Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • IDT Biologika GmbH
  • Solupharm Pharmazeutische Erzeugnisse GmbH
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 1325
Date of authorisation status change:
Reference member state:
  • Poland
Procedure number:
  • PL/V/0106/001/MR

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 31/03/2023
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Labelling

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Polish (PDF)
Published on: 31/03/2023
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 31/03/2023
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