Veterinary Medicines

FIXR MYC-VAC

Authorised
  • Mycoplasma gallisepticum, strain MG-NEV45, Inactivated
  • Mycoplasma gallisepticum, strain MG-NEV40, Inactivated
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Product identification

Medicine name:
FIXR MYC-VAC
Fixr MYC-VAC, emulsie voor injectie voor kippen
Active substance:
  • Mycoplasma gallisepticum, strain MG-NEV45, Inactivated
  • Mycoplasma gallisepticum, strain MG-NEV40, Inactivated
Target species:
  • Chicken
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Mycoplasma gallisepticum, strain MG-NEV45, Inactivated
    40.00
    unit(s)
    /
    1.00
    Dose
  • Mycoplasma gallisepticum, strain MG-NEV40, Inactivated
    40.00
    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:
  • Netherlands
Package description:
  • Polystyrene box: 10 x 250 ml polypropylene bottles (Ph. Eur.) which are closed with elastomer stoppers (Ph.Eur.) and sealed with aluminium caps.
  • Carton box: 1 x 250 ml polypropylene bottle (Ph. Eur.) which are closed with elastomer stoppers (Ph.Eur.) and sealed with 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:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 127755
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0363/001
Concerned member states:
  • Belgium
  • Czechia
  • Hungary
  • Portugal
  • Romania
  • Spain

Documents

Combined File of all Documents

English (PDF)
Published on: 9/10/2023
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Dutch (PDF)
Published on: 24/01/2024
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