Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CEFUROXIME AXETIL
Sandoz Ltd
125 Milligram
Tablets
2006-12-08
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0372/009/001 Case No: 2052305 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to SANDOZ LTD 37 WOOLMER WAY, BORDON, HANTS GU35 9QE, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product CEFUROXIME 125 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 25/08/2008 until 07/12/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/09/2008_ _CRN 2052305_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefuroxime 125mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 150.36 mg cefuroxime axetil which is equivalent to 125 mg cefuroxime per tablet. For excipients: see 6.1. 3 PHARMACEUTICAL FORM Coated tablets. White to slightly yellowish, biconvex, oblong tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefuroxime axetil is indicated for the treatment of mild to moderately severe infections caused by micro-organisms susceptible to cefuroxime, such as: - upper respiratory tract infections: acute otitis media, sinusitis, tonsillitis and pharyngitis - acute bronchitis, acute exacerbations of Read the complete document