IMOCOLIBOV

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Inactivated e.coli (antigen k99), Inactivated e.coli (antigen y), Inactivated e.coli (antigen 31a), Inactivated e.coli serotype 09, Inactivated e.coli serotype 08, Inactivated e.coli serotype 015, Inactivated e.coli serotype 078, Inactivated e.coli serotype 0101, Inactivated e.coli serotype 00117

متاح من:

Merial Animal Health Limited

ATC رمز:

QI02AC

INN (الاسم الدولي):

Inactivated e.coli (antigen k99), Inactivated e.coli (antigen y), Inactivated e.coli (antigen 31a), Inactivated e.coli serotype

جرعة:

percent

الشكل الصيدلاني:

Suspension for injection

نوع الوصفة الطبية :

LM: Licensed Merchant as defined in relevant national legislation

المجموعة العلاجية:

Cattle, Sheep

المجال العلاجي:

Inactivated bacterial vaccines and antisera QI04AC Inactivated bacterial vaccines and antisera

الخصائص العلاجية:

Immunological - Inactivated Vaccine

الوضع إذن:

Authorised

تاريخ الترخيص:

2003-08-06

خصائص المنتج

IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA:
10857/033/001
Case No: 7004886
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:
IMOCOLIBOV
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 revoked, shall continue in force from
22/09/2008
.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
(NOTE: 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
IMOCOLIBOV
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of vaccine contains_ E. coli_ somatic serotypes 09, 08, 015,
078, 0101, 0117, expressi