Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
GLICLAZIDE
Les Laboratoires Servier
GLICLAZIDE
30 Milligram
Modified-release Tablets
Product subject to prescription which may be renewed (B)
Withdrawn
2010-07-27
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0568/007/002 Case No: 2074702 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to LES LABORATOIRES SERVIER 22, RUE GARNIER, 92200 NEUILLY-SUR-SEINE, FRANCE an authorisation, subject to the provisions of the said Regulations, in respect of the product GLICLAZIDE SERVIER 30 MG, MODIFIED RELEASE TABLET. 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 29/03/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 08/06/2010_ _CRN 2074702_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gliclazide Servier 30 mg, modified release tablet. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains gliclazide 30 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified release tablet. White, oblong tablet engraved on both faces, ‘DIA 30’ on one face and on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Non insulin-dependent diabetes (type 2) in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral use. For adult use only. The daily dose Přečtěte si celý dokument