DOXAZOSIN DISPHAR
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
11-05-2024
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Active ingredient:
DOXAZOSIN MESILATE
Available from:
Helsinn Birex Therapeutics Ltd
Dosage:
2mg Milligram
Pharmaceutical form:
Tablets
Authorization date:
2005-05-27
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0915/012/002
Case No: 2021543
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
DOXAZOSIN DISPHAR 2MG 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 25/06/2007 until 21/04/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 27/06/2007_
_CRN 2021543_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Doxazosin Disphar 2mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Doxazosin 2mg (as mesilate).
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White, oblong tablets with 'D2' embossed on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Doxazosin is indicated for first-line treatment of hypertension and can be used as monotherapy to control blood
pressure in these patients. The drug can also be used in combination with a thiazide diuretic, beta-blocking agent,
calcium antagonists or ACE inhibitors when treatment with diuretics or beta-blockers alone has not given the desired
effect
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