Veterinary Medicine Information website

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
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:
  • Denmark
Available in:
  • Denmark
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 International B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Intervet International B.V.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 61408
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

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Danish (, LYOFILISAT OG SOLVENS TIL INJEKTIONSVÆSKE, EMULSION)
Published on: 7/10/2024
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Combined File of all Documents

English (PDF)
Published on: 14/03/2026
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eu-puar-frv0357001-mr-rpe784-en.pdf

English (PDF)
Published on: 13/03/2026
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