GALLIMUNE 302 ND+IB+EDS Water-in oil emulsion for injection
GALLIMUNE 302 ND+IB+EDS Water-in oil emulsion for injection
Authorised
- Newcastle disease virus, strain Ulster 2C, Inactivated
- Avian infectious bronchitis virus, type Massachusetts, strain M41, Inactivated
- Egg drop syndrome '76 virus, strain V127, Inactivated
Product identification
Medicine name:
GALLIMUNE 302 ND+IB+EDS Water-in oil emulsion for injection
Gallimune 302 ND+IB+EDS
Active substance:
- Newcastle disease virus, strain Ulster 2C, Inactivated
- Avian infectious bronchitis virus, type Massachusetts, strain M41, Inactivated
- Egg drop syndrome '76 virus, strain V127, Inactivated
Target species:
-
Chicken (for reproduction)
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Newcastle disease virus, strain Ulster 2C, Inactivated10.00log10 haemagglutination inhibiting unit(s)0.30millilitre(s)
-
Avian infectious bronchitis virus, type Massachusetts, strain M41, Inactivated10.00log10 haemagglutination inhibiting unit(s)0.30millilitre(s)
-
Egg drop syndrome '76 virus, strain V127, Inactivated162.00log10 haemagglutination inhibiting unit(s)0.30millilitre(s)
Pharmaceutical form:
-
Emulsion for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Chicken (for reproduction)
-
Egg0day
-
Meat and offal0day
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI01AA13
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Germany
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 Vetmedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
- Boehringer Ingelheim Animal Health France
Responsible authority:
- Paul-Ehrlich-Institut
Authorisation number:
- PEI.V.01042.01.1
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)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
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