BICALUTAMIDE Film Coated Tablet 150 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-04-2024
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Active ingredient:
BICALUTAMIDE
Available from:
Pliva Pharma Limited
Dosage:
150 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2008-11-14
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)
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
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