Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
FENOFIBRATE
Abbott Healthcare Products Ltd
145 Milligram
Coated Tablets
2007-01-05
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0108/030/005 Case No: 2077632 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ABBOTT HEALTHCARE PRODUCTS LTD MANSBRIDGE ROAD, WEST END, SOUTHAMPTON SO18 3JD, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product LIPANTIL SUPRA 145MG FILM-COATED TABLETS 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 21/06/2010 until 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 20/07/2010_ _CRN 2077632_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lipantil Supra 145mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 145.0 mg fenofibrate (nanoparticles). _For excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Film coated tablet. White, oblong, film-coated tablets engraved “145” on one side and “Fournier logo” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolaemia and hypertriglyceridaemia alone or combined (types IIa, IIb, IV dyslipidaemias, as well as types III and V dyslipidaemias ) in patients unresponsive to dietary and other non-drug therapeutic measures (e. Đọc toàn bộ tài liệu