Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
NYSTATIN
Bristol-Myers Squibb Pharmaceuticals Ltd
25,000 Units/Gram
Vaginal Cream
1977-04-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0002/007/009 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/4G VAGINAL 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/4g Vaginal Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 4 g application contains 100,000 units nystatin. Excipients: each 4g application contains 0.856g propylene glycol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Vaginal cream. Off-white to pale yellow smooth soft vanishing-type cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The treatment of vaginal infections due to _Candida albicans_. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: Insert 1 or 2 applications (of 4g each) high into the vagina for 14 consecutive nights, or longer, regardless of an Izlasiet visu dokumentu