GALLIVAC IBD

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

BURSAL DISEASE VIRUS, INFECTIOUS (ATTENUATED STRAIN S706)

Commercializzato da:

Merial Animal Health Limited

Codice ATC:

QI01AD09

INN (Nome Internazionale):

BURSAL DISEASE VIRUS, INFECTIOUS (ATTENUATED STRAIN S706)

Dosaggio:

Per Cent

Forma farmaceutica:

Lyophilisate for suspension

Tipo di ricetta:

POM

Gruppo terapeutico:

Fowl - Chicken

Area terapeutica:

Avian infectious bursal disease virus vaccine (Gumboro disease)

Indicazioni terapeutiche:

Immunological - Live Vaccine

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2006-12-21

Scheda tecnica

IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10857/049/001
Case No: 7005344
The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) hereby
grants to:
MERIAL ANIMAL HEALTH LIMITED
SANDRINGHAM HOUSE, SANDRINGHAM AVENUE, HARLOW BUSINESS PARK, HARLOW, ESSEX CM19 5TG, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations and the general conditions of the attached authorisation, in respect of the
Veterinary Medicinal Product:
GALLIVAC IBD
The particulars of which are set out in Part 1 and Part 2 of the said Schedule. The authorisation is also subject to any special conditions as may
be specified in the said Schedule.
The authorisation, unless previously revoked, shall continue in force from 15/05/2009.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
(NOTE: From this date of effect, this authorisation replaces any previous authorisation in respect of this product which is now null and void.)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 16/05/2009_
_CRN 7005344_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
GALLIVAC IBD
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose contains:
Active ingredient:
Infectious Bursal Disease virus, attenuated strain S706, at least
10
4.0
CCID
50
Excipient :
qs 1 dose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate for suspension
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens (broilers, future layers and broiler breeders).
4.2 IN