Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
MIRTAZAPINE
Ergha Healthcare Ltd
30 Milligram
Film Coated Tablet
2005-10-21
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0966/013/001 Case No: 2043671 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ERGHA HEALTHCARE LTD DAMASTOWN, MULHUDDART, DUBLIN 15, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product BEXZIS 30 MG FILM-COATED TABLETS The particulars of which are set out in Part I and Part II of 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 15/05/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/03/2010_ _CRN 2043671_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT BexZis 30mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30 mg of mirtazapine. Excipients Each tablet contains 226.66 mg lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Reddish brown, round tablets. One side of the tablet has a scoreline with the marking ”9” on one side of the scoreline and the number ”3” on the other. The other side of the tablet is marked with the number ”7207”. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of episodes of major depression. Read the complete document