Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
GLIBENCLAMIDE
B & S Healthcare
5 Milligram
Tablets
2006-09-29
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1328/060/001 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 DAONIL 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 31/03/2009 until 28/09/2011. 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 Daonil 5mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg glibenclamide. Excipients include lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. _Product imported from France and Spain:_ White biplane oblong tablets with ‘LDI’ engraved on each side of the scoreline and inverted on one side, the other side is plain. 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 alon Przeczytaj cały dokument