Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
GLICLAZIDE
B & S Healthcare
30 Milligram
Modified-release Tablets
2006-09-22
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1328/010/002 Case No: 2052901 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to B & S HEALTHCARE UNIT 4, BRADFIELD ROAD, RUISLIP, MIDDLESEX, HA4 0NU, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product DIAMICRON MR 30 MG, MODIFIED-RELEASE 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 31/03/2009 until 21/09/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 31/03/2009_ _CRN 2052901_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diamicron MR 30 mg, Modified-release Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified release tablet contains 30 mg gliclazide. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified release tablet. _Product imported from the Netherlands:_ White, oblong tablet engraved on both faces, ‘DIA 30’ on one face and the Servier logo 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 Διαβάστε το πλήρες έγγραφο