Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
SALMONELLA ENTERITIDIS PHAGE TYPE 4 INACTIVATED
Pfizer Healthcare Ireland
QI01AB01
Emulsion for Injection
Immunological - Inactivated vaccine
Fowl - Chicken
2010-05-14
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) 10019/176/001 Case No: 7007815 Transferred from 10861/093/001. The Irish Medicines Board in exercise of the powers conferred on it by the Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) hereby grants to: PFIZER HEALTHCARE IRELAND RINGASKIDDY, CO. CORK, IRELAND 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: POULVAC ISE 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 14/05/2010 until 30/05/2011. 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 27/05/2010_ _CRN 7007815_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT POULVAC iSE 2 QUALITATIVE AND QUANTITATIVE COMPOSITION * Potency : statistical reduction of _Salmonella _Enteritidis positive birds in vaccination/challenge test. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Emulsion for injection. Homogeneous white-ivory emulsion. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens (future breeder and future layer pullets). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of 12 Read the complete document