MYCOSPOR 1 %w/w Cutaneous Solution
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
BIFONAZOLE
Available from:
Bayer Limited
INN (International Name):
BIFONAZOLE
Dosage:
1 %w/w
Pharmaceutical form:
Cutaneous Solution
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Withdrawn
Authorization date:
2010-03-10
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA1410/049/004
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/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 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/v Cutaneous Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The solution contains 1% w/v bifonazole.
For excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution
A clear, colourless solution.
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 CONTRAI
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