Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
GLIMEPIRIDE
Medis ehf
2mg Milligram
Tablets
2006-04-13
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1285/016/002 Case No: 2039802 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to MEDIS EHF MEDIS EHF, REYKJAVIKURVEGUR 78, 220 HAFNARFJOROUR, ICELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product GLIMEPIRIDE 2 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 13/09/2007 until 21/07/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 30/11/2007_ _CRN 2039802_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glimepiride 2 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg of glimepiride. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Tablet. Green, scored, oblong, flat with bevelled edges. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Glimepiride 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 The basis for successful treatment of diabetes is a good diet, regular physical activity, as well as routine checks of blood and urine. Tablets or insulin can not compens Läs hela dokumentet