IMOCOLIBOV

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

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

Commercializzato da:

Merial Animal Health Limited

Codice ATC:

QI02AC

INN (Nome Internazionale):

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

Dosaggio:

percent

Forma farmaceutica:

Suspension for injection

Tipo di ricetta:

LM: Licensed Merchant as defined in relevant national legislation

Gruppo terapeutico:

Cattle, Sheep

Area terapeutica:

Inactivated bacterial vaccines and antisera QI04AC Inactivated bacterial vaccines and antisera

Indicazioni terapeutiche:

Immunological - Inactivated Vaccine

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2003-08-06

Scheda tecnica

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