Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TERBINAFINE
PIERRE FABRE DERMATOLOGIE
250 Milligram
Tablets
2008-06-20
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1230/002/001 Case No: 2051538 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to Transferred from PA0969/010/001. PIERRE FABRE DERMATOLOGIE 45 PLACE ABEL-GANCE, 92100 BOULOGNE CEDEX, FRANCE an authorisation, subject to the provisions of the said Regulations, in respect of the product FUNGSTER 250MG 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 20/06/2008 until 10/04/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 24/06/2008_ _CRN 2051538_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fungster 250 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 281.25 mg terbinafine hydrochloride equivalent to 250 mg terbinafine. (For a full list of excipients see section 6.1) 3 PHARMACEUTICAL FORM Tablet White, or almost white, round, biconvex tablets with a breakline on one side and 250 engraved on the other. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. Treatment of Terbinafine sensitive fungal infections such as Tinea corporis, Tinea cruris and Tinea pedis (caused by Dematophytes see Section 5.1 Read the complete document