Veterinary Medicines

SUIGEN APP 2,9,11 EMULSION FOR INJECTION FOR PIGS

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

Medicine name:
SUIGEN APP 2,9,11 EMULSION FOR INJECTION FOR PIGS
Suigen APP 2,9,11, Emulsion zur Injektion für Schweine
Active substance:
  • Actinobacillus pleuropneumoniae, APX II toxoid
  • Actinobacillus pleuropneumoniae, serotype 9 and 11, Inactivated
  • Actinobacillus pleuropneumoniae, APX I toxoid
  • Actinobacillus pleuropneumoniae, serotype 2, strain WSLB 3012, Inactivated
  • Actinobacillus pleuropneumoniae, APX III toxoid
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Actinobacillus pleuropneumoniae, APX II toxoid
    1.00
    relative potency
    /
    1.00
    millilitre(s)
  • Actinobacillus pleuropneumoniae, serotype 9 and 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, serotype 2, strain WSLB 3012, Inactivated
    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
        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:
  • Germany
Package description:
  • Plastic box of 10 x 10 ml (10 x 10 doses) in 10 ml glass vial hydrolytic class I
  • Cardboard box of 1 x 250 ml (1 x 250 doses) in 250 ml HDPE plastic vial
  • Cardboard box of 1 x 100 ml (1 x 100 doses) in 120 ml HDPE plastic vial
  • Cardboard box of 1 x 100 ml (1 x 100 doses) in 100 ml glass vial hydrolytic class II
  • Cardboard box of 1 x 50 ml (1 x 50 doses) in 60 ml HDPE plastic vial
  • Cardboard box of 1 x 50 ml (1 x 50 doses) in 50 ml glass vial hydrolytic class II
  • Cardboard box of 1 x 10 ml (1 x 10 doses) in 15 ml HDPE plastic vial
  • Cardboard box of 1 x 10 ml (1 x 10 doses) in 10 ml glass vial hydrolytic class I

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - known active substance (Article 8 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Virbac
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Paul-Ehrlich-Institut
Authorisation number:
  • PEI.V.12153.01.1
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0465/001
Concerned member states:
  • Germany

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Published on: 24/07/2023
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