BICALINN 50 Milligram Film Coated Tablet

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

BICALUTAMIDE

제공처:

Sinclair IS Pharma Limited

INN (International Name):

BICALUTAMIDE

복용량:

50 Milligram

약제 형태:

Film Coated Tablet

처방전 유형:

Product subject to prescription which may not be renewed (A)

승인 상태:

Withdrawn

승인 날짜:

2012-02-28

제품 특성 요약

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