Veterinary Medicines

Porcilis APP suspension for injection for pigs

Authorised
  • Actinobacillus pleuropneumoniae, Inactivated
  • Actinobacillus pleuropneumoniae, outer membrane protein
  • Actinobacillus pleuropneumoniae, APX I toxoid
  • Actinobacillus pleuropneumoniae, APX II toxoid
  • Actinobacillus pleuropneumoniae, APX III toxoid
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Product identification

Medicine name:
Porcilis APP suspension for injection for pigs
Porcilis APP suspension for injection for pigs
Active substance:
  • Actinobacillus pleuropneumoniae, Inactivated
  • Actinobacillus pleuropneumoniae, outer membrane protein
  • 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, Inactivated
    600.00
    milligram(s)
    /
    1.00
    Dose
  • Actinobacillus pleuropneumoniae, outer membrane protein
    50.00
    unit(s)
    /
    1.00
    Dose
  • Actinobacillus pleuropneumoniae, APX I toxoid
    50.00
    unit(s)
    /
    1.00
    Dose
  • Actinobacillus pleuropneumoniae, APX II toxoid
    50.00
    unit(s)
    /
    1.00
    Dose
  • Actinobacillus pleuropneumoniae, APX III toxoid
    50.00
    unit(s)
    /
    1.00
    Dose
Pharmaceutical form:
  • Suspension 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 not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Package description:
  • Carton with one glass bottle type I (Ph. Eur.) or PET bottle with halogenated rubber stoppers and aluminium closures, containing 250 ml (125 doses).
  • Carton with one glass bottle type I (Ph. Eur.) or PET bottle with halogenated rubber stoppers and aluminium closures, containing 100 ml (50 doses).
  • Carton with one glass bottle type I (Ph. Eur.) or PET bottle with halogenated rubber stoppers and aluminium closures, containing 50 ml (25 doses).
  • Carton with one glass bottle type I (Ph. Eur.) or PET bottle with halogenated rubber stoppers and aluminium closures, containing 20 ml (10 doses).

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:
  • Intervet (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Intervet International B.V.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10996/100/001
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0327/001
Concerned member states:
  • Croatia
  • Luxembourg
  • Norway
  • Portugal
  • Romania
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 25/09/2024
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