Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
GLIMEPIRIDE
Winthrop Pharmaceuticals UK Limited
GLIMEPIRIDE
1 Milligram
Tablets
Withdrawn
2008-01-31
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1046/015/001 Case No: 2041428 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to WINTHROP PHARMACEUTICALS UK LIMITED ONE ONSLOW STREET, GUILDFORD, SURREY, GU1 4YS, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product GLIMEPIRIDE 1 MG 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 17/12/2007 until 23/07/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/12/2007_ _CRN 2041428_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glimepiride 1mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1mg glimepiride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. The tablets are pink, oblong and scored on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Glimepiride Winthrop is indicated for the treatment of type 2 diabetes mellitus, when diet, physical exercise and weight reduction alone are not adequate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration The basis for successful treatment of diabetes is a good diet, regular physical activi Read the complete document