Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
TAMSULOSIN HYDROCHLORIDE
Astellas Pharma Co. Ltd
TAMSULOSIN HYDROCHLORIDE
0.4 Milligram
Capsule
Withdrawn
2010-04-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1241/007/001 Case No: 2053044 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ASTELLAS PHARMA CO. LTD 25 THE COURTYARD, KILCARBERY BUSINESS PARK, CLONDALKIN, DUBLIN 22, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product OMNIC 0.4 MG, MODIFIED RELEASE CAPSULES 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 25/11/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 25/11/2008_ _CRN 2053044_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Omnic 0.4 mg, modified release capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains as active ingredient tamsulosin hydrochloride 0.4 mg. Excipient(s): For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified release capsule, hard Orange/olive-green coded 0.4 and logo and 701 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral use One capsule daily, to be taken after breakfast or the first meal of the day. The capsule Lugege kogu dokumenti