BICALUTAMIDE Film Coated Tablet 150 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
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Active ingredient:
BICALUTAMIDE LACTOSE MONOHYDRATE SODIUM STARCH GLYCOLLATE POVIDONE K30 SILICA COLLOIDALIS ANHYDRICA MAGNESIUM STEARATE
Available from:
Gedeon Richter Plc
Dosage:
150 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2008-11-28
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA1330/004/002
Case No: 2078605
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
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 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 22/02/2010 until 21/08/2013.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 22/02/2010_
_CRN 2078605_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bicalutamide 150 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 150 mg of bicalutamide.
Excipients: Contains 193.2 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 "X" on one side, and "RG" on the other
side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BICALUTAMIDE150 MG FILM-COATED TABLET is indicated either alone or as adjuvant to radical prostatectomy or
radiotherapy in patients with locally advanced prostate cancer at high
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