Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
CICLOPIROX
Sanofi-Aventis Ireland Limited
10 %v/v
Shampoo
2005-08-26
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0540/032/005 Case No: 2072051 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to SANOFI-AVENTIS IRELAND LIMITED CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product BATRAFEN 10MG/G SHAMPOO 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 05/11/2009 until 25/08/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 05/11/2009_ _CRN 2072051_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Batrafen 10mg/g Shampoo 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One gram shampoo contains 10 mg ciclopirox. For excipients see section 6.1. 3 PHARMACEUTICAL FORM Shampoo Almost colourless to yellowish, translucent solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Batrafen 10mg/g Shampoo is indicated for the treatment of seborrhoeic dermatitis of the scalp. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For cutaneous use. For the initial treatment of the symptoms of seborrhoeic dermatitis Batrafen 10mg/g Shampoo is applied on the scalp once or twice a week, depending on severity, for four weeks. For subseque Lesen Sie das vollständige Dokument