CASODEX Film Coated Tablet 50 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
BICALUTAMIDE
Available from:
G & A Licensing Limited
Dosage:
50 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2008-05-16
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)
PPA1447/017/001
Case No: 2045968
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
G & A LICENSING LTD
BALLYMURRAY, CO. ROSCOMMON, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CASODEX 50MG 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 16/05/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 22/05/2008_
_CRN 2045968_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Casodex 50 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50mg bicalutamide.
Also contains: Lactose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets
_Product imported from Spain:_
Round, white, biconvex, intagliated with ‘CDX50’ on one face and a logo on the reverse.
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 Casodex should
Read the complete document
