Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
GLIMEPIRIDE
Actavis Group PTC ehf
4 Milligram
Tablets
2008-10-17
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1380/019/004 Case No: 2063329 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ACTAVIS GROUP PTC EHF REYKJAVIKURVEGI 76-78, 220 HAFNARFJORDUR, ICELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product GLEMIDE 4 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 21/07/2009 until 16/10/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 17/08/2009_ _CRN 2063329_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glemide 4 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Glemide 4 mg tablets Each tablet contains 4 mg of glimepiride. Excipient: lactose monohydrate 139.60 mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Description: Flat, oblong tablets with bevelled edges. Marking “G” on one side, scored on the other side. Glemide 4 mg tablets are blue in colour and 10.1 x 5.1 mm in size. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Glemide is indicated for the treatment of type 2 diabetes mellitus, when diet, physical exercise an Soma hati kamili