Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
LT TOXOID AND E. COLI ANTIGENS, K88AB, K88AC, K99 AND 987P
Intervet Ireland Limited
QI09AB02
Emulsion for Injection
Immunological - Inactivated vaccine
Porcine
2002-10-24
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10996/099/001 Case No: 7004495 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: INTERVET IRELAND LIMITED MAGNA DRIVE, MAGNA BUSINESS PARK, DUBLIN 24, 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: PORCILIS PORCOL 5 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 27/10/2007. 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 27/06/2008_ _CRN 7004495_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis Porcol 5 2 QUALITATIVE AND QUANTITATIVE COMPOSITION * Effective dose 50% in potency (seroconversion) test For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Emulsion for injection 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (sows and gilts) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the passive immunisation of piglets by active immunisation of sows/gilts to reduce mortality and clinical signs such as diarrhoea due to neonatal e Lire le document complet