Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
CLOTRIMAZOLE
Bayer PLC
CLOTRIMAZOLE
1%w/w %w/w
Cutaneous Powder
Withdrawn
2008-02-22
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0021/004/006 Case No: 2038189 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to BAYER PLC BAYER HOUSE, STRAWBERRY HILL, NEWBURY, BERKSHIRE RG14 1JA, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product CANESTEN DERMATOLOGICAL POWDER 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 26/07/2007 until 20/09/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 22/09/2007_ _CRN 2038189_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Canesten Dermatological Powder 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Clotrimazole 1% w/w. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Cutaneous powder White, fine powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Canesten Dermatological Powder should be used as an adjunct in the management of infections caused by microorganisms sensitive to clotrimazole and as a prophylactic against re-infection. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Canesten Dermatological Powder should be sprinkled onto the infected areas two to three times daily after using Canesten Cream or Canesten Dermatologica Lesen Sie das vollständige Dokument