FLUTAPLEX Tablets 250 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
FLUTAMIDE
Available from:
Pharmachemie BV
Dosage:
250 Milligram
Pharmaceutical form:
Tablets
Authorization date:
1999-08-23
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0937/001/001
Case No: 2016336
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
PHARMACHEMIE BV
SWENSWEG 5,, P.O. BOX 552, 2003 RN HAARLEM, NETHERLANDS
an authorisation, subject to the provisions of the said Regulations, in respect of the product
FLUTAPLEX
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 09/01/2006 until 22/08/2009 .
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 10/01/2006_
_CRN 2016336_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flutaplex
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 250mg flutamide.
For excipients see 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Flutaplex is a yellow tablet with
inscription ‘Flutamide 250’.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Flutamide tablets are indicated for the treatment of advanced prostatic carcinoma in which suppression of testosterone
effect is indicated.
Flutamide is used in the palliative treatment of metastasized,
inoperable carcinoma of the prostate, in combination with
an LH-RH agonist or surgical castration.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Adults:
The recommended adult dose, including the elderl
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