GALLIVAC IBD

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Infectious bursal disease virus, attenuated strain S706

Tillgänglig från:

Merial Animal Health Limited

ATC-kod:

QI01AD09

INN (International namn):

Infectious bursal disease virus, attenuated strain S706

Dos:

.

Läkemedelsform:

Lyophilisate for suspension

Receptbelagda typ:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk grupp:

Chickens

Terapiområde:

avian infectious bursal disease virus (gumboro disease)

Terapeutiska indikationer:

Immunological - Live Vaccine

Bemyndigande status:

Authorised

Tillstånd datum:

2006-12-21

Produktens egenskaper

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.)
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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 Bu