国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
MIRTAZAPINE
Profind Wholesale Ltd
MIRTAZAPINE
45 Milligram
Orodispersible Tablet
Product subject to prescription which may not be renewed (A)
Withdrawn
2013-01-29
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PPA1500/066/002 Case No: 2083999 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PROFIND WHOLESALE LTD. UNIT 625, KILSHANE AVENUE, NORTHWEST BUSINESS PARK, DUBLIN 15, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product ZISPIN SOLTAB 45MG ORODISPERSIBLE TABLETS the particulars of which are set out in the attached Schedule. The authorisation is also subject to the general conditions as may be specified in the said Regulations as listed on the reverse of this document. This authorisation, unless previously revoked, shall continue in force from 08/10/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 11/10/2010_ _CRN 2083999_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zispin Sol Tab 45mg orodispersible tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each oro-dispersible tablet contains 45 mg of mirtazapine. Excipients: Contains aspartame and sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet. _Product imported from UK:_ Round, white, standard bevelled-edge, coded with ‘TZ/4’ on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of episodes of major depression. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults The effective daily dose is usually between 15 and 45 mg; the starting dose is 15 or 30mg. Mirtazapine b 阅读完整的文件