Veterinary Medicine Information website

FIXR APP 2,9,11, Emulsion for injection

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

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

Product details

Active substance and strength:
  • Actinobacillus pleuropneumoniae, serovar 2, strain WSLB 3012, Inactivated
    1.00
    relative potency
    /
    1.00
    millilitre(s)
  • Actinobacillus pleuropneumoniae, serovar 9, strain WSLB 3013, Inactivated
    1.00
    relative potency
    /
    1.00
    millilitre(s)
  • Actinobacillus pleuropneumoniae, serovar 11, Inactivated
    1.00
    relative potency
    /
    1.00
    millilitre(s)
  • Actinobacillus pleuropneumoniae, APX I toxoid
    1.00
    relative potency
    /
    1.00
    millilitre(s)
  • Actinobacillus pleuropneumoniae, APX II toxoid
    1.00
    relative potency
    /
    1.00
    millilitre(s)
  • Actinobacillus pleuropneumoniae, APX III toxoid
    1.00
    relative potency
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AB07
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • Glass Vial 1 x 10 Dose (1 dose = 1 ml)
  • Plastic Vial 1 x 10 Dose (1 dose = 1 ml)
  • Glass Vial 10 x 10 Dose (1 dose = 1 ml)
  • Plastic Vial 10 x 10 Dose (1 dose = 1 ml)
  • Glass Vial 1 x 50 Dose (1 dose = 1 ml)
  • Plastic Vial 1 x 50 Dose (1 dose = 1 ml)
  • Glass Vial 1 x 100 Dose (1 dose = 1 ml)
  • Plastic Vial 1 x 100 Dose (1 dose = 1 ml)
  • Plastic Bottle 1 x 250 Dose (1 dose = 1 ml)

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:
  • Kernfarm B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
  • Kernfarm B.V.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
This information is not available for this product.
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0430/001
Concerned member states:
  • Belgium
  • Czechia

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 17/08/2025
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French (PDF)
Published on: 17/08/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 17/08/2025
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German (PDF)
Published on: 17/08/2025
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French (PDF)
Published on: 17/08/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 17/08/2025
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German (PDF)
Published on: 17/08/2025
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French (PDF)
Published on: 17/08/2025
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Combined File of all Documents

English (PDF)
Published on: 18/07/2024
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FIXR APP_PuAR.pdf

English (PDF)
Published on: 15/05/2024
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