Veterinary Medicines

Enterisol Ileitis lyophilisate and diluent for oral suspension for pigs

Authorised
  • Lawsonia intracellularis, strain MS B3903, Live
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Product identification

Medicine name:
Enterisol Ileitis lyophilisate and diluent for oral suspension for pigs
Enterisol Ileitis liofilizat i rozpuszczalnik do sporządzania zawiesiny doustnej dla świń
Active substance:
  • Lawsonia intracellularis, strain MS B3903, Live
Target species:
  • Pig
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Lawsonia intracellularis, strain MS B3903, Live
    1258930.00
    tissue culture infective dose 50
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate and solvent for oral suspension
Withdrawal period by route of administration:
  • Oral use
    • Pig
      • Meat and offal
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AE04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:
  • (ID8): 1 Box with 12 Box with (1 Bottle (Glass) with 100 Dose and 1 Bottle (High Density PolyEthylene) with 200 millilitre(s)) (1200.0 Dose, 2400.0 millilitre(s))
  • (ID6): 1 Box with (1 Bottle (Glass) with 100 Dose and 1 Bottle (High Density PolyEthylene) with 200 millilitre(s)) (100.0 Dose, 200.0 millilitre(s))
  • (ID4): 1 Box with (1 Bottle (Glass) with 50 Dose and 1 Bottle (High Density PolyEthylene) with 100 millilitre(s)) (50.0 Dose, 100.0 millilitre(s))
  • (ID2): 1 Box with (1 Bottle (Glass) with 10 Dose and 1 Bottle (High Density PolyEthylene) with 20 millilitre(s)) (10.0 Dose, 20.0 millilitre(s))

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Immunological veterinary medicinal product application (Article 13d of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Boehringer Ingelheim Vetmedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Boehringer Ingelheim Vetmedica GmbH
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 1624
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0236/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 14/02/2022
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Polish (PDF)
Published on: 21/03/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 21/03/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 6/02/2023
Download
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