Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
TERBINAFINE HYDROCHLORIDE
Norton Waterford
250 Milligram
Tablets
2005-04-22
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0436/038/001 Case No: 2084796 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to NORTON WATERFORD T/A IVAX PHARMACEUTICALS IRELAND, UNIT 301, IDA INDUSTRIAL PARK, CORK ROAD, WATERFORD, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product FUNGAFINE 250MG 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 05/07/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 05/07/2010_ _CRN 2084796_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fungafine 250 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 mg terbinafine, as terbinafine hydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, round, flat, 11 mm tablets, scored on both sides with side scores, marked “T” above and “1” below the score on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS N.B. Orally administered terbinafine tablets are not effective against _Pityriasis versicolor_. The official local guidelines should be borne in mind, for example, national recommendations relating to the correct use and pre Прочитајте комплетан документ