Novamune Concentrate and Solvent for Suspension for Injection for Chickens
Novamune Concentrate and Solvent for Suspension for Injection for Chickens
Authorised
- Infectious bursal disease virus, Live
Product identification
Medicine name:
Novamune Concentrate and Solvent for Suspension for Injection for Chickens
Novamune Concentraat voor suspensie voor injectie
Novamune Suspension à diluer pour suspension injectable
Novamune Konzentrat zur Herstellung einer Injectionssuspension
Active substance:
- Infectious bursal disease virus, Live
Target species:
-
Chicken
Route of administration:
-
Subcutaneous use
Product details
Active substance and strength:
-
Infectious bursal disease virus, Live4.20log 10 50% infective dose in chicken1.00Dose
Pharmaceutical form:
-
Concentrate and solvent for suspension for injection
Withdrawal period by route of administration:
-
Subcutaneous use
- Chicken
-
Meat and offal0day
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI01AD09
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- bag containing 1600 ml
- bag containing 1200 ml
- bag containing 1000 ml
- bag containing 800 ml
- bag containing 400 ml
- bag containing 200 ml
- ampoule of 5 ml containing 2000 doses
- ampoule of 5 ml containing 1000 doses
- ampoule of 5 ml containing 500 doses
- ampoule of 2 ml containing 1000 doses
- ampoule of 2 ml containing 500 doses
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Ceva Sante Animale
Marketing authorisation date:
Manufacturing sites for batch release:
- Ceva-Phylaxia Veterinary Biologicals Co. Ltd.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V534062
Date of authorisation status change:
Reference member state:
-
Spain
Procedure number:
- ES/V/0365/001
Concerned member states:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Cyprus
-
Czechia
-
Denmark
-
Estonia
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Ireland
-
Italy
-
Latvia
-
Lithuania
-
Netherlands
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Sweden
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Package Leaflet
This document does not exist in this language (English). You can find it in another language below.
eu-PUAR-novamune-concentrate-and-solvent-for-suspension-for-injection-for-chickens-en.pdf
English (PDF)
Download Published on: 12/04/2023
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