Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
TRICHOPHYTON VERRUCOSUM STRAIN LTF-130
Intervet Ireland Limited
QI02AP01
Lyophilisate and solvent for suspension for injection
Immunological - Live Vaccine
Bovine
2005-05-04
IRISH MEDICINES BOARD ACT 1995 ANIMAL REMEDIES REGULATIONS, 2005 (S.I. NO. 734 OF 2005) VPA: 10996/184/001 Case No: 7000605 The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies Regulations (S.I. No. 734 of 2005) 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: BOVILIS RINGVAC 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 17/07/2006. 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 10/11/2006_ _CRN 7000605_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Bovilis Ringvac, lyophilisate for suspension for injection, for cattle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Per 1 ml of vaccine: ACTIVE SUBSTANCE: Attenuated _Trichophyton verrucosum, _strain LTF-130 9 x 10 6 and 21 x 10 6 viable microconidia. EXCIPIENTS: For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPE Đọc toàn bộ tài liệu