Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
GLIMEPIRIDE
Profind Wholesale Ltd.
4 Milligram
Tablets
2010-06-25
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PPA1500/063/002 Case No: 2083479 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PROFIND WHOLESALE LTD. UNIT 625, KILSHANE AVENUE, NORTHWEST BUSINESS PARK, DUBLIN 15, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product AMARYL 4MG TABLETS the particulars of which are set out in 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 28/07/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/07/2010_ _CRN 2083479_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amaryl 4mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4mg glimepiride Excipient(s): lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet _Product imported from _Italy: Light blue oblong tablets scored on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amaryl 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 activity, as well as ro Olvassa el a teljes dokumentumot