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NOBILIS E.COLI INAC

Authorised
  • Escherichia coli, fimbrial adhesin F11
  • Escherichia coli, flagellar toxin
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Product identification

Medicine name:
NOBILIS E.COLI INAC
Active substance:
  • Escherichia coli, fimbrial adhesin F11
  • Escherichia coli, flagellar toxin
Target species:
  • Chicken
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Escherichia coli, fimbrial adhesin F11
    100.00
    microgram(s)
    /
    0.50
    millilitre(s)
  • Escherichia coli, flagellar toxin
    100.00
    microgram(s)
    /
    0.50
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Chicken
      • Meat and offal
        35
        day
      • Egg
        no withdrawal period
  • Subcutaneous use
    • Chicken
      • Meat and offal
        35
        day
      • Egg
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AB05
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Available in:
  • Netherlands
Package description:
  • 250 ml (500 doses) in one glass type II vial closed with a nitryl rubber stopper and sealed with a coded aluminium cap in a cardboard box.
  • 500 ml (1000 doses) in one glass type II vial closed with a nitryl rubber stopper and sealed with a coded aluminium cap in a cardboard box.
  • 500 ml (1000 doses) in one PET vial closed with a nitryl rubber stopper and sealed with a coded aluminium cap in a cardboard box.
  • 250 ml (500 doses) in one PET vial closed with a nitryl rubber stopper and sealed with a coded aluminium cap in a cardboard box.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Legal basis not covered by Directive 2001/82/EC
Marketing authorisation holder:
  • Intervet Nederland B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Intervet International B.V.
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 8266
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0017/001
Concerned member states:
  • Austria
  • Belgium
  • France
  • Germany
  • Greece
  • Ireland
  • Italy
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

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Dutch (PDF)
Published on: 19/01/2022
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