Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
BICALUTAMIDE LACTOSE MONOHYDRATE SODIUM STARCH GLYCOLLATE POVIDONE K30 SILICA COLLOIDALIS ANHYDRICA MAGNESIUM STEARATE
Gedeon Richter Plc
50 Milligram
Film Coated Tablet
2008-11-28
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1330/004/001 Case No: 2058633 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to Transferred from PA1425/001/001. GEDEON RICHTER LTD GYOMROI UT 19-21, 1103 BUDAPEST, HUNGARY an authorisation, subject to the provisions of the said Regulations, in respect of the product BICALUTAMIDE 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 28/11/2008 until 20/07/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/11/2008_ _CRN 2058633_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bicalutamide 50 mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 50 mg of bicalutamide. Excipients: Contains 64.4 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White or almost white, round, biconvex film-coated tablet, with engraved sign ,,L’’on one side, and ,,RG’’on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of advanced prostate cancer in combination with luteinizing hormone-releasing hormone (LHRH) analogue therapy or surgical castration. 4.2 Đọc toàn bộ tài liệu