IMOCOLIBOV

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

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

Available from:

Merial Animal Health Limited

ATC code:

QI02AC

INN (International Name):

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

Dosage:

percent

Pharmaceutical form:

Suspension for injection

Prescription type:

LM: Licensed Merchant as defined in relevant national legislation

Therapeutic group:

Cattle, Sheep

Therapeutic area:

Inactivated bacterial vaccines and antisera QI04AC Inactivated bacterial vaccines and antisera

Therapeutic indications:

Immunological - Inactivated Vaccine

Authorization status:

Authorised

Authorization date:

2003-08-06

Summary of Product characteristics

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