Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
PORCINE REPRODUCTIVE AND RESPIRATORY SYNDROME VIRUS INACTIVATED
Boehringer Ingelheim Ltd
QI09AA05
Emulsion for Injection
Immunological - Inactivated vaccine
Porcine
2003-06-06
IRISH MEDICINES BOARD ACT 1995, AS AMENDED EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 VPA: 10007/037/001 Case No: 7006775 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: BOEHRINGER INGELHEIM LTD ELLESFIELD AVENUE, BRACKNELL, BERKSHIRE RG12 8YS, ENGLAND 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: INGELVAC PRRS KV EMULSION FOR INJECTION FOR PIGS (SOWS AND GILTS). The particulars of which are set out in the attached Schedule. The authorisation is also subject to any special conditions as may be specified in the Schedule. The authorisation,unless revoked, shall continue in force from 11/05/2010. 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 04/09/2010_ _CRN 7006775_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Ingelvac PRRS KV emulsion for injection for pigs (sows and gilts). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Inactivated Porcine Reproductive and Respiratory Syndrome (PRRS) virus, P120 strain: 2.5 log10 IF* Units. *IF Units: ImmunoFluorescence antibody titre obtained after two injections in pigs under specific laboratory conditions. ADJUVANT: O/w oily excipient (containing hydrogenated polyisobutene as adjuvant): q.s. 1 dose of 2 ml. EXCIPIENTS: For a full lis Baca dokumen lengkapnya