Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
METFORMIN HYDROCHLORIDE
Morningside Healthcare Limited
850 Milligram
Film Coated Tablet
2007-08-24
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1333/001/002 Case No: 2040752 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to MORNINGSIDE HEALTHCARE LIMITED 115 NARBOROUGH ROAD, LEICESTER LE3 0PA, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product METFORMIN HYDROCHLORIDE 850MG 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 21/11/2007 until 23/08/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 22/11/2007_ _CRN 2040752_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Metformin Hydrochloride 850mg film coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains; Metformin Hydrochloride 850 mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet White, circular, bi-convex film-coated tablet with diameter of 13.5 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycemic control. IN ADULTS, METFORMIN may be used as monothe Read the complete document