Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
BIFONAZOLE
Bayer Limited
1 %w/w
Cutaneous Powder
2008-10-24
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1410/049/003 Case No: 2068861 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to BAYER LIMITED THE ATRIUM, BLACKTHORN ROAD, DUBLIN 18, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product MYCOSPOR 1% W/W CUTANEOUS POWDER 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 08/10/2009 until 21/11/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 08/10/2009_ _CRN 2068861_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mycospor 1% w/w Cutaneous Powder 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The powder contains 1% w/w bifonazole. For excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Cutaneous Powder A fine white dusting powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of fungal skin infections due to dermatophytes, yeasts, moulds and other fungi. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Sprinkle on to the affected areas once daily. Mycospor Powder may also be dusted inside articles of clothing and footwear which are in contact with the infected area. The affected area should be washed and dried thoroughly Read the complete document