国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
CELECOXIB
Profind Wholesale Ltd
CELECOXIB
200 Milligram
Capsules Hard
Product subject to prescription which may be renewed (B)
Withdrawn
2013-05-23
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PPA1500/038/001 Case No: 2083758 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 CELEBREX 200 MG CAPSULES, HARD 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 2083758_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Celebrex 200 mg capsules, hard. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 200mg celecoxib Excipients: contains lactose monohydrate For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsule, hard. _Product imported from Italy :_ Opaque, white capsule with two gold bands marked 7767 and 200 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic relief in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks (see sections 4.3, 4.4) 阅读完整的文件