Veterinary Medicines

GALLIMUNE 302 ND+IB+EDS Water-in oil emulsion for injection

Authorised
  • Eggdrop syndrome-1976 virus, strain V127, Inactivated
  • Avian infectious bronchitis virus, type Massachusetts, strain M41, Inactivated
  • Newcastle disease virus, strain Ulster 2C, Inactivated
Download as PDF

Product identification

Medicine name:
GALLIMUNE 302 ND+IB+EDS Water-in oil emulsion for injection
GALLIMUNE 302 ND+IB+EDS emulzija za injiciranje
Active substance:
  • Eggdrop syndrome-1976 virus, strain V127, Inactivated
  • Avian infectious bronchitis virus, type Massachusetts, strain M41, Inactivated
  • Newcastle disease virus, strain Ulster 2C, Inactivated
Target species:
  • Chicken (for reproduction)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Eggdrop syndrome-1976 virus, strain V127, Inactivated
    162.00
    log10 haemagglutination inhibiting unit(s)
    /
    0.30
    millilitre(s)
  • Avian infectious bronchitis virus, type Massachusetts, strain M41, Inactivated
    10.00
    log10 haemagglutination inhibiting unit(s)
    /
    0.30
    millilitre(s)
  • Newcastle disease virus, strain Ulster 2C, Inactivated
    10.00
    log10 haemagglutination inhibiting 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:
  • QI01AA13
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovenia
Package description:
  • (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))
  • (ID3): 1 Box with 1 Bottle (PolyPropylene) with 300 millilitre(s) (300 millilitre(s))
  • (ID4): 1 Box with 10 Bottle (PolyPropylene) with 300 millilitre(s) (3000 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 France
Marketing authorisation date:
Manufacturing sites for batch release:
  • Boehringer Ingelheim Animal Health France
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • 2000-2005/2008
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0227/001
Concerned member states:
  • Belgium
  • Cyprus
  • Czechia
  • Denmark
  • Finland
  • France
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 28/01/2022
Download
Slovenian (PDF)
Published on: 22/07/2024
Download

Combined File of all Documents

English (PDF)
Published on: 20/10/2023
Download

Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 22/07/2024
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."