Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
BICALUTAMIDE
Helsinn Birex Therapeutics Ltd
50 Milligram
Film Coated Tablet
2008-09-12
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0915/015/001 Case No: 2070471 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to HELSINN BIREX THERAPEUTICS LTD DAMASTOWN, MULHUDDART, DUBLIN 15, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product BICALINN 50 MG 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 18/12/2009 until 11/09/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 05/01/2010_ _CRN 2070471_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bicalinn 50 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg bicalutamide. Also contains 60 mg of lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White, round, biconvex film-coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of advanced prostate cancer in combination with LHRH analogue therapy or surgical castration. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adult males including the elderly: One tablet (50 mg) once a day. Treatment with Bicalinn should be started Pročitajte cijeli dokument