Veterinary Medicines

Hyobac App Multi Vet., emulsion for injection

Authorised
  • Actinobacillus pleuropneumoniae, APX III toxoid
  • Actinobacillus pleuropneumoniae, APX I toxoid
  • Actinobacillus pleuropneumoniae, serotype 5, strain WSLB 3079, Inactivated
  • Actinobacillus pleuropneumoniae, serotype 6, strain WSLB 3075, Inactivated
  • Actinobacillus pleuropneumoniae, serotype 2, strain WSLB 3012, Inactivated
  • Actinobacillus pleuropneumoniae, APX II toxoid
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Product identification

Medicine name:
Hyobac App Multi Vet., emulsion for injection
Hyobac App Multi Vet. Injektionsvätska, emulsion
Active substance:
  • Actinobacillus pleuropneumoniae, APX III toxoid
  • Actinobacillus pleuropneumoniae, APX I toxoid
  • Actinobacillus pleuropneumoniae, serotype 5, strain WSLB 3079, Inactivated
  • Actinobacillus pleuropneumoniae, serotype 6, strain WSLB 3075, Inactivated
  • Actinobacillus pleuropneumoniae, serotype 2, strain WSLB 3012, Inactivated
  • Actinobacillus pleuropneumoniae, APX II toxoid
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Actinobacillus pleuropneumoniae, APX III toxoid
    1.00
    relative potency
    /
    1.00
    millilitre(s)
  • Actinobacillus pleuropneumoniae, APX I toxoid
    1.00
    relative potency
    /
    1.00
    millilitre(s)
  • Actinobacillus pleuropneumoniae, serotype 5, strain WSLB 3079, Inactivated
    1.00
    relative potency
    /
    1.00
    millilitre(s)
  • Actinobacillus pleuropneumoniae, serotype 6, strain WSLB 3075, Inactivated
    1.00
    relative potency
    /
    1.00
    millilitre(s)
  • Actinobacillus pleuropneumoniae, serotype 2, strain WSLB 3012, Inactivated
    1.00
    relative potency
    /
    1.00
    millilitre(s)
  • Actinobacillus pleuropneumoniae, APX II 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
        0
        day
      • Meat and offal
        0
        day
      • Meat and offal
        0
        day
      • Meat and offal
        0
        day
      • Meat and offal
        0
        day
      • Meat and offal
        0
        day
      • Meat and offal
        0
        day
      • Meat and offal
        0
        day
      • Meat and offal
        0
        day
      • Meat and offal
        0
        day
      • Meat and offal
        0
        day
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AB07
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Sweden
Available in:
  • Sweden
Package description:
  • Available only in Swedish
  • Available only in Swedish
  • 100 ml in vial (HDPE) in paper cardboard

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:
  • Salfarm Danmark A/S
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
  • USKVBL
Responsible authority:
  • Swedish Medical Products Agency
Authorisation number:
  • 55370
Date of authorisation status change:
Reference member state:
  • Denmark
Procedure number:
  • DK/V/0121/001
Concerned member states:
  • Finland
  • Norway
  • Sweden

Documents

Summary of Product Characteristics

English (PDF)
Published on: 25/01/2022
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Swedish (PDF)
Published on: 2/05/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Swedish (PDF)
Published on: 2/05/2022
Download
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