GALLIVAC IBD

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

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Prenos Lastnosti izdelka (SPC)
12-06-2017

Aktivna sestavina:

Infectious bursal disease virus, attenuated strain S706

Dostopno od:

Merial Animal Health Limited

Koda artikla:

QI01AD09

INN (mednarodno ime):

Infectious bursal disease virus, attenuated strain S706

Odmerek:

.

Farmacevtska oblika:

Lyophilisate for suspension

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtska skupina:

Chickens

Terapevtsko območje:

avian infectious bursal disease virus (gumboro disease)

Terapevtske indikacije:

Immunological - Live Vaccine

Status dovoljenje:

Authorised

Datum dovoljenje:

2006-12-21

Lastnosti izdelka

                                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
                                
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