国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
NIMESULIDE
Sinclair IS Pharma Limited
NIMESULIDE
3.0 %w/w
Gel
Product subject to prescription which may be renewed (B)
Withdrawn
2010-10-31
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0915/001/003 Case No: 2070812 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to HELSINN BIREX THERAPEUTICS LTD DAMASTOWN, MULHUDDART, DUBLIN 15, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product MESULID 3 %W/W GEL 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 10/12/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 25/03/2010_ _CRN 2070812_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mesulid 3% w/w Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Mesulid 3% w/w gel contains 3% w/w nimesulide (1 g of gel contains 30 mg of nimesulide). Excipients: Methyl parahydroxybenzoate 0.80% w/w Propyl parahydroxybenzoate 0.02% w/w For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Gel. Opalescent, pale yellow gel. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic relief of pain associated with sprains and acute traumatic tendinitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: Nimesulide 3% w/w gel (usually 3 g, corresponding to a line 6-7 cm long) should be applied in a thin layer to the aff 阅读完整的文件