البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
TAMSULOSIN HYDROCHLORIDE
McDowell Pharmaceuticals
TAMSULOSIN HYDROCHLORIDE
400 Microgram
Tablet Prolonged Release
Product subject to prescription which may be renewed (B)
Withdrawn
2013-11-09
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1473/037/001 Case No: 2071278 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 OMNEXEL, 400 MICROGRAMS, PROLONGED RELEASE TABLETS, FILM-COATED. 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 08/01/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 11/01/2010_ _CRN 2071278_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Omnexel, 400 micrograms, prolonged release tablets, film-coated. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged release film-coated tablet contains 400 micrograms tamsulosin hydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated, prolonged release tablet. _Product imported from the UK:_ Round, bi-convex, yellow, film-coated and debossed with the code ’04’ on one side, and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). 4.2 POSOLOGY AND اقرأ الوثيقة كاملة