Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
CEFUROXIME AXETIL
Rowex Ltd
CEFUROXIME AXETIL
125 Milligram
Coated Tablets
Product subject to prescription which may not be renewed (A)
Withdrawn
2010-07-27
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0711/101/001 Case No: 2082950 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ROWEX LTD BANTRY, CO. CORK, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product CEFTAL 125MG 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 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 2082950_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ceftal 125mg coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ceftal 125 mg contains 150.36 mg cefuroxime axetil which is equivalent to 125 mg cefuroxime per tablet Excipients: aspartame (E951) 0.2mg For a full list of excipients: see section 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 chronic bronch Pročitajte cijeli dokument