Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DOXAZOSIN MESILATE
McDowell Pharmaceuticals
4 Milligram
Tablets
2009-02-20
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1473/006/001 Case No: 2066413 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to MCDOWELL PHARMACEUTICALS 4 ALTONA ROAD, LISBURN, N. IRELAND, BT27 5QB an authorisation, subject to the provisions of the said Regulations, in respect of the product CARDURA XL 4MG PROLONGED-RELEASE 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 08/12/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 08/12/2009_ _CRN 2066413_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cardura XL 4mg Prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4mg doxazosin (as mesilate) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablets. _Product importedfrom the UK;_ Cardura XL 4mg are white, round, biconvex shaped tablets with an orifice on one side marked ‘CXL4’ and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cardura XL is indicated for the treatment of hypertension and can be used as a sole agent to control blood pressure in hypertensive patients. In patients inadequately controlled on sin Read the complete document