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
Download as PDF

Product identification

Medicine name:
GALLIMUNE 303 ND+IB+ART Water-in oil emulsion for injection
GALLIMUNE 303 ND+IB+ART
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:
  • Italy
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 Italia S.p.A. In Breve Boehringer Ingelheim Ah It S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Boehringer Ingelheim Animal Health France
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 103715
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
Download

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Italian (PDF)
Published on: 5/02/2024
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."