PRIMUN NEWCASTLE HB1 Lyophilisate for suspension for chickens
PRIMUN NEWCASTLE HB1 Lyophilisate for suspension for chickens
Authorised
- Newcastle disease virus, strain B1 Hitchner, Live
Product identification
Medicine name:
PRIMUN NEWCASTLE HB1 Lyophilisat zur Herstellung einer Suspension für Hühner
PRIMUN NEWCASTLE HB1 Lyophilisate for suspension for chickens
Active substance:
- Newcastle disease virus, strain B1 Hitchner, Live
Target species:
-
Chicken
Route of administration:
-
Oculonasal use
Product details
Active substance and strength:
-
Newcastle disease virus, strain B1 Hitchner, Live6.00log 10 50% embryo infective dose1.00Dose
Pharmaceutical form:
-
Lyophilisate for suspension for injection
Withdrawal period by route of administration:
-
Oculonasal use
- Chicken
-
Meat and offal0day
-
Egg0day
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI01AD06
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 (Glass) with 1000 Dose (10000 Dose)
- (ID2): 1 Box with 10 Bottle (Glass) with 1000 Dose (10000 Dose)
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:
- Laboratorios Calier S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- Laboratorios Calier S.A.
Responsible authority:
- Paul-Ehrlich-Institut
Authorisation number:
- PEI.V.11870.01.1
Date of authorisation status change:
Reference member state:
-
Germany
Procedure number:
- DE/V/0272/001
Concerned member states:
-
Italy
-
Poland
-
Portugal
-
Spain
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
English (PDF)
Download Published on: 28/01/2022
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