Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
BIFONAZOLE
Bayer Limited
BIFONAZOLE
1 %w/w
Gel
Product subject to prescription which may be renewed (B)
Withdrawn
2010-03-10
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1410/049/001 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 GEL 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 Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The gel contains 1% w/w bifonazole. For excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Gel A clear colourless gel. 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 After cleansing and drying the affected area, the preparation should be thinly applied and rubbed in once daily, preferably at night before retiring. Duration of treatment need not usually exceed four weeks. 4.3 CONTRAINDICATIONS Use in patients with hypersensitivity to i Belgenin tamamını okuyun