Veterinary Medicines

FIXR MS-VAC Emulsion for injection for chickens

Authorised
  • Mycoplasma synoviae, strain MS-NEV1, Inactivated
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Product identification

Medicine name:
FIXR MS-VAC Emulsion for injection for chickens
FIXR MS-VAC Emulsie voor injectie
FIXR MS-VAC Emulsion injectable
FIXR MS-VAC Emulsion zur Injektion
Active substance:
  • Mycoplasma synoviae, strain MS-NEV1, Inactivated
Target species:
  • Chicken
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Mycoplasma synoviae, strain MS-NEV1, Inactivated
    70.00
    unit(s)
    /
    1.00
    Dose
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Chicken
      • Meat and offal
        0
        day
      • Egg
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AB03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • Polypropylene bottles of 310 ml (extractable contents are 250 ml) with a closure of elastomer stoppers and aluminium 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:
  • Fatro S.p.A.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V560613
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0302/001
Concerned member states:
  • Belgium
  • Czechia
  • Germany
  • Hungary
  • Portugal
  • Romania
  • Spain
  • 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.
Dutch (PDF)
Published on: 30/08/2023
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French (PDF)
Published on: 30/08/2023
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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: 30/08/2023
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French (PDF)
Published on: 30/08/2023
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German (PDF)
Published on: 30/08/2023
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 30/08/2023
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French (PDF)
Published on: 30/08/2023
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German (PDF)
Published on: 30/08/2023
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