Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
TERBINAFINE HYDROCHLORIDE
Novartis Consumer Health UK Limited
1.0 %w/w
Cream
2003-01-24
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0030/044/002 Case No: 2060127 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to NOVARTIS CONSUMER HEALTH UK LTD WIMBLEHURST ROAD, HORSHAM, WEST SUSSEX RH12 5AB, ENGLAND an authorisation, subject to the provisions of the said Regulations, in respect of the product LAMISIL AT CREAM 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 12/01/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 13/01/2009_ _CRN 2060127_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lamisil AT Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Terbinafine hydrochloride 1.0% w/w. Excipients: Each gram of cream contains 40mg stearyl alcohol and 40mg cetyl alcohol For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream. White smooth or almost smooth, glossy cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The treatment of tinea pedis (athlete’s foot) and tinea cruris (dhobie itch/jock itch) caused by Trichophyton _(e.g. T._ _rubrum, T. mentagrophytes, T. verrucosum, T. violaceum) and Epidermophyton floccosum_. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION METHOD OF ADMINISTRATION To সম্পূর্ণ নথি পড়ুন