Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
GALANTAMINE HYDROBROMIDE
Rowex Ltd
8 Milligram
Film Coated Tablet
2008-02-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0711/114/002 Case No: 2025548 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 GALTAM 8MG FILM-COATED 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 01/02/2008 until 31/01/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 06/03/2008_ _CRN 2025548_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Galtam 8mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 8 mg Galantamine (as hydrobromide). Excipient: 99.227mg lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Pink coloured, oval, biconvex film-coated tablets plain on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Galantamine is indicated for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer type. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS/ELDERLY _Administration_ Galantamine should be administered twice a day, preferably with morning and Прочитать полный документ