Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
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
Merial Animal Health Limited
QI02AC
INACTIVATED E.COLI (ANTIGEN K99), INACTIVATED E.COLI (ANTIGEN Y), INACTIVATED E.COLI (ANTIGEN 31A), INACTIVATED E.COLI SEROTYPE
Per Cent
Suspension for Injection
LM-Licensed Merchant
Bovine, Ovine
Inactivated bacterial vaccines and antisera QI04AC Inactivated bacterial vaccines and antisera
Immunological - Inactivated vaccine
Authorised
2003-08-06
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.) IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 23/09/2008_ _CRN 7004886_ _page number: 1_ 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, expressing virulence factors: Active substances: * 1 SA.U: q.s. to obtain an agglutinating antibody titre of 1 log 10 in guinea-pigs after two administrations of vaccine. ** OD – Optical Density For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection. Read the complete document