Veterinary Medicines

Hyobac App 2 Vet., emulsion for injection

Authorised
  • Actinobacillus pleuropneumoniae, serotype 2, strain WSLB 3012, APX II toxoid
  • Actinobacillus pleuropneumoniae, serotype 2, strain WSLB 3012, APX III toxoid
  • Actinobacillus pleuropneumoniae, serotype 2, strain WSLB 3012, Inactivated
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Product identification

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

Product details

Active substance and strength:
  • Actinobacillus pleuropneumoniae, serotype 2, strain WSLB 3012, APX II toxoid
    1.00
    relative potency
    /
    1.00
    millilitre(s)
  • Actinobacillus pleuropneumoniae, serotype 2, strain WSLB 3012, APX III toxoid
    1.00
    relative potency
    /
    1.00
    millilitre(s)
  • Actinobacillus pleuropneumoniae, serotype 2, strain WSLB 3012, Inactivated
    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
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AB07
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Available in:
  • Denmark
Package description:
  • 100 ml in vial (HDPE) in paper cardboard
  • 100 ml in vial (type II glass) 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.
Responsible authority:
  • Danish Health And Medicines Authority
Authorisation number:
  • 48942
Date of authorisation status change:
Reference member state:
  • Denmark
Procedure number:
  • DK/V/0120/001
Concerned member states:
  • Sweden

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Danish (, INJEKTIONSVÆSKE, EMULSION)
Published on: 29/06/2023
Download

PI Hyobac App 2.pdf

English (PDF)
Published on: 25/01/2022
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