Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
PORCINE PARVOVIRUS STRAIN NADL-2, PPV-PK-7
Fort Dodge Animal Health Limited
QI09AA02
Suspension for Injection
Immunological - Inactivated vaccine
Porcine
2002-10-23
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) REGULATIONS 2007 (S.I. NO. 144 OF 2007) VPA: 10861/050/001 Case No: 7003442 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 LIMITED 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 PARVO 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 previously revoked, shall continue in force from 23/10/2007. Signed on behalf of the Irish Medicines Board ________________ A person authorised in that behalf by the said Board. (NOTE: From this date of effect, this authorisation replaces any previous authorisation in respect of this product which is now null and void.) IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/09/2007_ _CRN 7003442_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Suvaxyn Parvo 2 QUALITATIVE AND QUANTITATIVE COMPOSITION * 50% Tissue Culture Infective Dose, prior to inactivation For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Gilts and sows aged six months or greater. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of gilts and sows to reduce parvovirus related still birth, foeta Прочетете целия документ