국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
MELOXICAM
Norton Waterford
15 Milligram
Tablets
2004-09-10
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0436/036/002 Case No: 2053828 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to NORTON WATERFORD T/A IVAX PHARMACEUTICALS IRELAND, IDA INDUSTRIAL PARK, WATERFORD, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product MOVOX 15 MG 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 14/01/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 27/05/2009_ _CRN 2053828_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Movox 15 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: 15 mg meloxicam Excipient: Each tablet contains 81.70 mg lactose (as lactose monohydrate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Pale yellow coloured round tablet with a score line on one side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short-term symptomatic treatment of exacerbations of osteoarthrosis. Long-term symptomatic treatment of rheumatoid arthritis or ankylosing spondylitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ORAL USE Exacerbations 전체 문서 읽기