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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
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