Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
GLIBENCLAMIDE
Sanofi-Aventis Ireland Limited
2.5 Milligram
Tablets
1998-09-11
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0540/040/001 Case No: 2070442 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to SANOFI-AVENTIS IRELAND LIMITED CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product SEMI-DAONIL 2.5MG 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 05/02/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 05/02/2010_ _CRN 2070442_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Semi-Daonil 2.5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Glibenclamide 2.5 mg Excipients: contains Lactose Monohydrate 39.5mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, flat, round tablets, 6mm in diameter, ‘LB’ above and ‘G’ below a breakline on one side and plain on the other side. The score line allows the tablets to be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Daonil is a sulphonylurea hypoglycaemic agent indicated for the oral treatment of patients with non-insulin dependent diabetes who respond inadequately to dietary measures Baca dokumen lengkap