Veterinary Medicines

FIXR Ery One

Authorised
  • Erysipelothrix rhusiopathiae, serotype 2, strain 2-II, Inactivated
  • Erysipelothrix rhusiopathiae, serotype 1, strain 1-203, Inactivated
  • Erysipelothrix rhusiopathiae, serotype 2, strain 2-5, Inactivated
  • Erysipelothrix rhusiopathiae, serotype 2, strain 2-64, Inactivated
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Product identification

Medicine name:
FIXR Ery One
FIXR Ery One Emulsie voor injectie
FIXR Ery One Emulsion injectable
FIXR Ery One Emulsion zur Injektion
Active substance:
  • Erysipelothrix rhusiopathiae, serotype 2, strain 2-II, Inactivated
  • Erysipelothrix rhusiopathiae, serotype 1, strain 1-203, Inactivated
  • Erysipelothrix rhusiopathiae, serotype 2, strain 2-5, Inactivated
  • Erysipelothrix rhusiopathiae, serotype 2, strain 2-64, Inactivated
Target species:
  • Pig
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Erysipelothrix rhusiopathiae, serotype 2, strain 2-II, Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Erysipelothrix rhusiopathiae, serotype 1, strain 1-203, Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Erysipelothrix rhusiopathiae, serotype 2, strain 2-5, Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Erysipelothrix rhusiopathiae, serotype 2, strain 2-64, Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Pig
      • Meat and offal
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AB03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • 5 x 20 ml glass class II vials closed with chlorobutyl rubber penetrable stoppers and sealed with aluminium or flip-off caps
  • 10 x 10 ml glass class I vials closed with chlorobutyl rubber penetrable stoppers and sealed with aluminium or flip-off caps
  • 1 x 50 ml glass class II vials closed with chlorobutyl rubber penetrable stoppers and sealed with aluminium or flip-off caps
  • 1 x 100 ml glass class II vials closed with chlorobutyl rubber penetrable stoppers and sealed with aluminium or flip-off caps
  • 1 x 100 ml HDPE vials closed with chlorobutyl rubber penetrable stoppers and sealed with aluminium or flip-off caps
  • 1 x 10 ml glass class I vials closed with chlorobutyl rubber penetrable stoppers and sealed with aluminium or flip-off caps

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Similar biological application (Article 13(4) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Kernfarm B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
This information is not available for this product.
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0344/001
Concerned member states:
  • Belgium

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/03/2022
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French (PDF)
Published on: 22/03/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/03/2022
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French (PDF)
Published on: 22/03/2022
Download
German (PDF)
Published on: 22/03/2022
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