Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
ALFUZOSIN HYDROCHLORIDE
Profind Wholesale Ltd
ALFUZOSIN HYDROCHLORIDE
10 Milligram
Tablet Prolonged Release
Product subject to prescription which may be renewed (B)
Withdrawn
2013-01-29
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PPA1500/024/001 Case No: 2083742 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PROFIND WHOLESALE LTD. UNIT 625, KILSHANE AVENUE, NORTHWEST BUSINESS PARK, DUBLIN 15, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product XATRAL 10MG PROLONGED RELEASE TABLETS the particulars of which are set out in 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 28/07/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/07/2010_ _CRN 2083742_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xatral 10mg Prolonged Release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg alfuzosin hydrochloride. Fora full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. _Product imported from the UK:_ Round biconvex three layer tablet: one white layer between two yellow layers. _Product imported from the Italy:_ 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 catheterization for Acute Urinary R Lesen Sie das vollständige Dokument