MYCOSTATIN Cream 100,000 International Unit
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
29-04-2024
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Active ingredient:
NYSTATIN
Available from:
Bristol-Myers Squibb Pharmaceuticals Ltd
Dosage:
100,000 International Unit
Pharmaceutical form:
Cream
Authorization date:
1977-04-01
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)
PA0002/007/002
Case No: 2035298
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTD
SWORDS, CO. DUBLIN, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
MYCOSTATIN 100,000 UNITS/G CREAM
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 01/04/2007.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 18/02/2009_
_CRN 2035298_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mycostatin 100,000 Units/g Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 100,000 units of nystatin.
Excipients: each gram of cream contains - 0.266g propylene glycol, and 0.01g 1,2 benzenedicarboxylic acid, diethyl
ester.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
Smooth, homogeneous, light yellow to buff coloured cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of cutaneous and mucocutaneous mycoses, particularly those caused by _Candida Albicans_.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children:
To be applied two to four tim
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