מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
BICALUTAMIDE
Pliva Pharma Limited
150 Milligram
Film Coated Tablet
2008-11-14
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0585/033/002 Case No: 2041277 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PLIVA PHARMA LIMITED VISION HOUSE, BEDFORD ROAD, PETERSFIELD, HAMPSHIRE GU32 3QB, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product BICALUTAMIDE 150 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 14/11/2008 until 13/11/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/11/2008_ _CRN 2041277_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bicalutamide 150mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150mg of bicalutamide Excipients: Each tablet contains 3.1mg of lactose (as lactose monohydrate) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White to almost white round, biconvex, film-coated tablet, imprinted with ‘BC’ on one side and ‘150’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bicalutamide 150mg is indicated either alone or as adjuvant to radical prostatectomy or radiotherapy in p קרא את המסמך השלם