国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
ALFUZOSIN HYDROCHLORIDE
Clonmel Healthcare Ltd
ALFUZOSIN HYDROCHLORIDE
10 Milligram
Tablet Prolonged Release
Withdrawn
2009-05-28
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0126/160/002 Case No: 2052342 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to CLONMEL HEALTHCARE LIMITED WATERFORD ROAD, CLONMEL, CO. TIPPERARY, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product BENPROTAN 10 MG 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 26/08/2008 until 14/12/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/10/2008_ _CRN 2052342_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Benprotan 10 mg Prolonged Release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg alfuzosin hydrochloride. Excipients: Each tablet conains 8 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet. White, round, bevelled-edge, uncoated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of moderate to severe functional symptoms of benign prostatic hyperplasia (BPH). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The prolonged-release tablet should be swallowed whole with a sufficient amount of fluid 阅读完整的文件