Veterinary Medicines

BIOSUIS Salm emulsion for injection for pigs

Authorised
  • Salmonella enterica, subsp. enterica, serovar Typhimurium, Inactivated
  • Salmonella enterica, subsp. enterica, serovar Derby, Inactivated
  • Salmonella enterica, subsp. enterica, serovar Infantis, strain A S03499-06, Inactivated
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Product identification

Medicine name:
BIOSUIS Salm emulsion for injection for pigs
Biosuis Salm Emulsja do wstrzykiwań
Active substance:
  • Salmonella enterica, subsp. enterica, serovar Typhimurium, Inactivated
  • Salmonella enterica, subsp. enterica, serovar Derby, Inactivated
  • Salmonella enterica, subsp. enterica, serovar Infantis, strain A S03499-06, Inactivated
Target species:
  • Pig (pregnant sow)
  • Pig (pregnant gilt)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Salmonella enterica, subsp. enterica, serovar Typhimurium, Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
  • Salmonella enterica, subsp. enterica, serovar Derby, Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
  • Salmonella enterica, subsp. enterica, serovar Infantis, strain A S03499-06, Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig (pregnant sow)
      • Meat and offal
        0
        day
    • Pig (pregnant gilt)
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AB14
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:
  • Glass Vial 1 x 10.0 Dose
  • Plastic Vial 1 x 50.0 Dose
  • Plastic Vial 1 x 100.0 Dose
  • Glass Vial 10 x 10.0 Dose

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:
  • Bioveta a.s.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2953
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0151/001
Concerned member states:
  • Austria
  • Belgium
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Netherlands
  • Poland
  • Slovakia
  • United Kingdom (Northern Ireland)

Documents

Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
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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: 4/02/2022
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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: 4/02/2022
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