Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
ALFUZOSIN HYDROCHLORIDE
Sanofi-Aventis Ireland Limited
10 Milligram
Tablet Prolonged Release
2007-08-10
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0540/163/001 Case No: 2067390 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to SANOFI-AVENTIS IRELAND LIMITED CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product ALFUZOSIN WINTHROP 10MG 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 16/09/2009 until 09/08/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/09/2009_ _CRN 2067390_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alfuzosin Winthrop 10mg Prolonged Release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg alfuzosin hydrochloride. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Tablet, prolonged release. Round biconvex three layer tablet: one white layer between two yellow layers. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of the functional symptoms of benign prostatic hypertrophy. Adjunctive therapy with urethral catheterisation for Acute Urinary Retention related to BPH. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Alfuzosin Winthrop 10mg prolonged release tablets Przeczytaj cały dokument