Veterinary Medicines

PORCILIS LAWSONIA LYOPHILISATE AND SOLVENT FOR EMULSION FOR INJECTION FOR PIGS

Authorised
  • Lawsonia intracellularis, strain SPAH-08, Inactivated
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Product identification

Medicine name:
PORCILIS LAWSONIA LYOPHILISATE AND SOLVENT FOR EMULSION FOR INJECTION FOR PIGS
Porcilis Lawsonia lyofilisaat en suspendeervloeistof voor emulsie voor injectie voor varkens
Active substance:
  • Lawsonia intracellularis, strain SPAH-08, Inactivated
Target species:
  • Pig (for fattening)
  • Pig (for reproduction)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Lawsonia intracellularis, strain SPAH-08, Inactivated
    5323.00
    unit(s)
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate and solvent for emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig (for fattening)
      • All relevant tissues
        0
        day
    • Pig (for reproduction)
      • All relevant tissues
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AB18
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Available in:
  • Netherlands
Package description:
  • Cardboard box with 1 x 50 doses of vaccine and cardboard box with 1 x 100 ml solvent
  • Cardboard box with 10 x 100 doses of vaccine and cardboard box with 10 x 200 ml solvent
  • Cardboard box with 1 x 100 doses of vaccine and cardboard box with 1 x 200 ml solvent
  • Cardboard box with 10 x 50 doses of vaccine and cardboard box with 10 x 100 ml solvent

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Intervet Nederland B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Intervet International B.V.
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 123502
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0357/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

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Dutch (PDF)
Published on: 10/06/2024
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