国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
LEVAMISOLE HYDROCHLORIDE, OXYCLOZANIDE BP (VET)
Norbrook Laboratories Limited
QP52AE51
LEVAMISOLE HYDROCHLORIDE, OXYCLOZANIDE BP (VET)
%v/v
Oral Suspension
LM-Licensed Merchant
Bovine, Ovine
Levamisole, combinations
Endoparasiticide
Authorised
1989-10-01
IRISH MEDICINES BOARD ACT 1995, AS AMENDED EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 VPA: 10999/036/001 Case No: 7006151 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: NORBROOK LABORATORIES LIMITED STATION WORKS, NEWRY, CO. DOWN BT35 6JP 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: LEVAFAS DIAMOND FLUKE AND WORM DRENCH 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 30/09/2009. 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 06/07/2010_ _CRN 7006151_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Levafas Diamond Fluke and Worm Drench 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Oral suspension. A yellow viscous suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, sheep. ACTIVE SUBSTANCES Levamisole hydrochloride 3.0 % w/v Oxyclozanide 6.0 % w/v EXCIPIENTS Sodium metabisulphite (E223) 0.15 % w/v Tartrazine (E102) 0.011 % w/v Sodium methyl parahydroxybenzoate (E219) 0.18 % w/v IRISH MEDICINES BOARD _____________________________________________________________________________________________ 阅读完整的文件