Veterinary Medicines

BIOSUIS APP 2, 9, 11, Emulsion for injection

Authorised
  • Actinobacillus pleuropneumoniae, Serotype 11, Inactivated
  • Actinobacillus pleuropneumoniae, APX I toxoid
  • Actinobacillus pleuropneumoniae, APX II toxoid
  • Actinobacillus pleuropneumoniae, APX III toxoid
  • Actinobacillus pleuropneumoniae, serotype 2, strain WSLB 3012, Inactivated
  • Actinobacillus pleuropneumoniae, serotype 9, strain WSLB 3013, Inactivated
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Product identification

Medicine name:
BIOSUIS APP 2, 9, 11, Emulsion for injection
BIOSUIS APP 2, 9, 11, Injekční emulze
Active substance:
  • Actinobacillus pleuropneumoniae, Serotype 11, Inactivated
  • Actinobacillus pleuropneumoniae, APX I toxoid
  • Actinobacillus pleuropneumoniae, APX II toxoid
  • Actinobacillus pleuropneumoniae, APX III toxoid
  • Actinobacillus pleuropneumoniae, serotype 2, strain WSLB 3012, Inactivated
  • Actinobacillus pleuropneumoniae, serotype 9, strain WSLB 3013, Inactivated
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Actinobacillus pleuropneumoniae, Serotype 11, Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
  • Actinobacillus pleuropneumoniae, APX I toxoid
    1.00
    relative potency
    /
    1.00
    Dose
  • Actinobacillus pleuropneumoniae, APX II toxoid
    1.00
    relative potency
    /
    1.00
    Dose
  • Actinobacillus pleuropneumoniae, APX III toxoid
    1.00
    relative potency
    /
    1.00
    Dose
  • Actinobacillus pleuropneumoniae, serotype 2, strain WSLB 3012, Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
  • Actinobacillus pleuropneumoniae, serotype 9, strain WSLB 3013, Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AB07
Legal status of supply:
This information is not available for this product.
Authorisation status:
  • Valid
Authorised in:
  • Czechia
Package description:
  • Glass Vial 1 x 10.0 Dose
  • Glass Vial 1 x 50.0 Dose
  • Glass Vial 1 x 100.0 Dose
  • Plastic Vial 1 x 10.0 Dose
  • Plastic Vial 1 x 50.0 Dose
  • Plastic Vial 1 x 100.0 Dose
  • Plastic Bottle 1 x 250.0 Dose
  • Glass Vial 10 x 10.0 millilitre(s)
  • Plastic Vial 10 x 10.0 millilitre(s)
  • Glass Vial 10 x 10.0 millilitre(s)
  • Plastic Vial 10 x 10.0 millilitre(s)

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:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 97/037/12-C
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0121/001
Concerned member states:
  • Croatia
  • Estonia
  • Greece
  • Hungary
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • Slovakia

Documents

Summary of Product Characteristics

English (PDF)
Published on: 24/05/2022
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Czech (PDF)
Published on: 24/05/2022
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Package Leaflet

English (PDF)
Published on: 24/05/2022
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Czech (PDF)
Published on: 24/05/2022
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Labelling

English (PDF)
Published on: 24/05/2022
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Czech (PDF)
Published on: 24/05/2022
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eu-puar-czv0121001-mr-biosuis_app_2,_9,_11-en.pdf

English (PDF)
Published on: 16/11/2023
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