Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
GLIMEPIRIDE
Sanofi-Aventis Ireland Limited
6.0mg Milligram
Tablets
2000-07-22
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0540/028/005 Case No: 2071509 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to SANOFI-AVENTIS IRELAND LIMITED CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product AMARYL 6 MG TABLET 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 20/02/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/04/2010_ _CRN 2071509_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amaryl 6 mg tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 6 mg glimepiride. Excipients: also contains 133.6 mg lactose monohydrate and 0.4 mg sunset yellow aluminium lake (E110) per tablet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet The tablets are orange, oblong and 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 treatme সম্পূর্ণ নথি পড়ুন