Gallimune Se + St, water-in oil emulsion for injection
Gallimune Se + St, water-in oil emulsion for injection
Authorised
- Salmonella enterica, subsp. enterica, serovar Typhimurium, strain DT104, Inactivated
- Salmonella enterica, subsp. enterica, serovar Enteritidis, strain PT4, Inactivated
Product identification
Medicine name:
Gallimune Se + St, water-in oil emulsion for injection
Gallimune SE+ST emulsion injectable
Active substance:
- Salmonella enterica, subsp. enterica, serovar Typhimurium, strain DT104, Inactivated
- Salmonella enterica, subsp. enterica, serovar Enteritidis, strain PT4, Inactivated
Target species:
-
Chicken (pullet)
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Salmonella enterica, subsp. enterica, serovar Typhimurium, strain DT104, Inactivated149.00antibody unit(s)0.30millilitre(s)
-
Salmonella enterica, subsp. enterica, serovar Enteritidis, strain PT4, Inactivated171.00antibody unit(s)0.30millilitre(s)
Pharmaceutical form:
-
Emulsion for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Chicken (pullet)
-
Meat and offal0day
-
Egg0day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI01AB01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Luxembourg
Package description:
- (ID2) 3000 millilitre(s): Box (Cardboard) with 10 Bottle (PolyPropylene) each with 300 millilitre(s)
- (ID1) 300 millilitre(s): Box (Cardboard) with 1 Bottle (PolyPropylene) with 300 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 Italia S.p.A. In Breve Boehringer Ingelheim Ah It S.p.A.
Responsible authority:
- Ministry Of Health
Authorisation number:
- V 344/07/06/0908
Date of authorisation status change:
Reference member state:
-
Germany
Procedure number:
- DE/V/0282/001
Concerned member states:
-
Austria
-
Belgium
-
Cyprus
-
Czechia
-
Denmark
-
France
-
Greece
-
Hungary
-
Ireland
-
Italy
-
Latvia
-
Lithuania
-
Luxembourg
-
Netherlands
-
Poland
-
Portugal
-
Slovakia
-
Slovenia
-
Spain
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
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