국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
ERYSIPELOTHRIX RHUSIOPATHIAE SUIS, STRAIN B-7 (SEROTYPE2) INACTIVATED
Fort Dodge Animal Health Limited
QI09AB03
Emulsion for Injection
Immunological - Inactivated vaccine
Porcine
2004-05-20
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) REGULATIONS 2007 (S.I. NO. 144 OF 2007) VPA: 10861/085/001 Case No: 7001230 The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies Regulations (S.I. No. 144 of 2007) hereby grants to: FORT DODGE ANIMAL HEALTH FLANDERS ROAD, HEDGE END, SOUTHAMPTON SO30 4QH, 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: SUVAXYN ERY 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. 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 29/06/2007_ _CRN 7001230_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Suvaxyn® Ery 2 QUALITATIVE AND QUANTITATIVE COMPOSITION * Relative Potency compared to a reference serum obtained from a vaccine that has given satisfactory protection in vaccinated pigs. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Emulsion for injection. Appearance: Ivory white oil emulsion. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (gilts and sows) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation of pigs (gilts and sows) to: Reduce clinical signs caused by _Erysipelothrix rhusiopathiae _infectio 전체 문서 읽기