ประเทศ: ไอร์แลนด์
ภาษา: อังกฤษ
แหล่งที่มา: HPRA (Health Products Regulatory Authority)
DOXAZOSIN MESILATE
Helsinn Birex Therapeutics Ltd
2mg Milligram
Tablets
2005-05-27
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 อ่านเอกสารฉบับเต็ม