Veterinary Medicines

GALLIMUNE 303 ND+IB+ART Water-in oil emulsion for injection

Authorised
  • Newcastle disease virus, strain Ulster 2C, Inactivated
  • Avian infectious bronchitis virus, type Massachusetts, strain M41, Inactivated
  • Turkey rhinotracheitis virus, strain VCO3, Inactivated
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Product identification

Medicine name:
GALLIMUNE 303 ND+IB+ART Water-in oil emulsion for injection
Gallimune ND+IB+ART Emulsion injectable
Active substance:
  • Newcastle disease virus, strain Ulster 2C, Inactivated
  • Avian infectious bronchitis virus, type Massachusetts, strain M41, Inactivated
  • Turkey rhinotracheitis virus, strain VCO3, Inactivated
Target species:
  • Chicken (for reproduction)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Newcastle disease virus, strain Ulster 2C, Inactivated
    50.00
    50% Protective Dose
    /
    0.30
    millilitre(s)
  • Avian infectious bronchitis virus, type Massachusetts, strain M41, Inactivated
    18.00
    log10 haemagglutination inhibiting unit(s)
    /
    0.30
    millilitre(s)
  • Turkey rhinotracheitis virus, strain VCO3, Inactivated
    0.76
    interference percentage unit(s)
    /
    0.30
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Chicken (for reproduction)
      • Egg
        0
        day
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AA21
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Luxembourg
Package description:
  • (ID4): 1 Box with 10 Bottle (PolyPropylene) with 300 millilitre(s) (3000 millilitre(s))
  • (ID3): 1 Box with 1 Bottle (PolyPropylene) with 300 millilitre(s) (300 millilitre(s))
  • (ID2): 1 Box with 10 Bottle (PolyPropylene) with 150 millilitre(s) (1500 millilitre(s))
  • (ID1): 1 Box with 1 Bottle (PolyPropylene) with 150 millilitre(s) (150 millilitre(s))

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:
  • Boehringer Ingelheim Animal Health Belgium S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Boehringer Ingelheim Animal Health France
Responsible authority:
  • Ministere De La Sante Division De La Pharmacie Et Des Medicaments
Authorisation number:
  • V 344/04/12/0816
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0228/001
Concerned member states:
  • Belgium
  • Cyprus
  • Denmark
  • Finland
  • France
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Portugal
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 15/02/2024
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French (PDF)
Published on: 21/06/2022
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