País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
TRIAMCINOLONE ACETONIDE NEOMYCIN SULFATE GRAMICIDIN NYSTATIN
Bristol-Myers Squibb Pharmaceuticals Ltd
TRIAMCINOLONE ACETONIDE NEOMYCIN SULFATE GRAMICIDIN NYSTATIN
1 Grams
Ointment
Withdrawn
2009-05-31
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0002/033/001 Case No: 2055949 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 KENACOMB OTIC OINTMENT. 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 16/12/2008 until 04/06/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/12/2008_ _CRN 2055949_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Kenacomb Otic Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1g of ointment contains: triamcinolone acetonide 0.1% w/w, neomycin sulphate (equivalent to neomycin) 0.25% w/w (1625 units), gramicidin 0.025% w/w, and nystatin 2% w/w (100,000 units). For excipients, see 6.1. 3 PHARMACEUTICAL FORM Ointment. A smooth, shiny amber to yellow coloured homogenous ear ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the topical management of corticosteroid sensitive cutaneous conditions infected or likely to be infected by organisms sensitive to the anti-infectives present. 4.2 POSOLOGY AND METHOD OF ADMINISTRAT Leer el documento completo