Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
CICLOPIROX OLAMINE
Sanofi-Aventis Ireland Limited
10 %v/v
Cutaneous Solution
2009-01-09
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0540/032/006 Case No: 2064842 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to SANOFI-AVENTIS IRELAND LIMITED CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product BATRAFEN 1% W/V CUTANEOUS SOLUTION 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 10/07/2009 until 17/12/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 10/07/2009_ _CRN 2064842_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Batrafen 1% w/v Cutaneous Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 10 mg ciclopiroxolamine in an alcoholic aqueous base. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous Solution Colourless to faintly yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS All fungal infections of the skin where rapid drying is an advantage. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Batrafen solution should be gently rubbed into the infected area twice a day. 4.3 CONTRAINDICATIONS Batrafen solution should not be used in patients with known hypersensitivity to any c Przeczytaj cały dokument