Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
GLIMEPIRIDE
Rowex Ltd
GLIMEPIRIDE
1 Milligram
Tablets
Withdrawn
2008-01-31
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0711/080/001 Case No: 2029953 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ROWEX LTD BANTRY, CO. CORK, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product GLEPID 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 12/03/2007 until 02/02/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 15/03/2007_ _CRN 2029953_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glepid 1 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg glimepiride For excipients see section 6.1. 3 PHARMACEUTICAL FORM Tablet. A light red, flat, oblong, scored tablet encoded G breakline 1 on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Glimepiride is indicated for 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. For the different dosage regimens appropriate strengths are available. The basis for successful treatment of diabetes is a good diet, regular physical activity, as well as routine checks of blood an Read the complete document