Veterinary Medicines

Nobilis IBmulti+ND+EDS Emulsion for injection (water-in-oil)

Authorised
  • Newcastle disease virus, strain Clone 30, Inactivated
  • Egg drop syndrome '76 virus, strain BC14, Inactivated
  • Avian infectious bronchitis virus, type D274/D207, strain 249g, Inactivated
  • Avian infectious bronchitis virus, type Massachusetts, strain M41, Inactivated
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Product identification

Medicine name:
Nobilis IBmulti+ND+EDS Emulsion for injection (water-in-oil)
Nobilis IBmulti-ND-EDS injektionsvæske, emulsion
Active substance:
  • Newcastle disease virus, strain Clone 30, Inactivated
  • Egg drop syndrome '76 virus, strain BC14, Inactivated
  • Avian infectious bronchitis virus, type D274/D207, strain 249g, Inactivated
  • Avian infectious bronchitis virus, type Massachusetts, strain M41, Inactivated
Target species:
  • Chicken (for reproduction)
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Newcastle disease virus, strain Clone 30, Inactivated
    2.00
    log10 haemagglutination inhibiting unit(s)
    /
    0.50
    millilitre(s)
  • Egg drop syndrome '76 virus, strain BC14, Inactivated
    2.70
    log10 haemagglutination inhibiting unit(s)
    /
    0.50
    millilitre(s)
  • Avian infectious bronchitis virus, type D274/D207, strain 249g, Inactivated
    2.00
    virus neutralising unit(s)
    /
    0.50
    millilitre(s)
  • Avian infectious bronchitis virus, type Massachusetts, strain M41, Inactivated
    2.46
    virus neutralising unit(s)
    /
    0.50
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Chicken (for reproduction)
      • Egg
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AA13
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Package description:
  • (ID1): 1 Box with 1 Bottle (PolyEthylene TerePhthalate) with 250 millilitre(s) (500 ID)
  • (ID2): 1 Box with 1 Bottle (PolyEthylene TerePhthalate) with 500 millilitre(s) (1000 ID)
  • (ID4): 1 Box with 1 Bottle (Glass) with 500 millilitre(s) (1000 ID)
  • (ID3): 1 Box with 1 Bottle (Glass) with 250 millilitre(s) (500 ID)

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:
  • Intervet International B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • INTERVET INTERNATIONAL B.V.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 38233
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0225/001
Concerned member states:
  • Belgium
  • Denmark
  • France
  • Ireland
  • Luxembourg
  • Sweden

Documents

Summary of Product Characteristics

English (PDF)
Published on: 9/08/2022
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Danish (PDF)
Published on: 4/05/2022
Download

Combined File of all Documents

English (PDF)
Published on: 5/06/2024
Download
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