Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
BENZOYL PEROXIDE
Galderma (UK) Ltd
10 %w/w
Gel
1992-12-17
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0590/007/002 Case No: 2047174 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to GALDERMA (UK) LTD MERIDIEN HOUSE, 69-71 CLARENDON ROAD, WATFORD, HERTS WD17 1DS, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product ACNECIDE 10 %W/W GEL 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 11/03/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/03/2008_ _CRN 2047174_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Acnecide 10% w/w Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Hydrous benzoyl peroxide equivalent to Benzoyl Peroxide 10 % w/w. Excipient: Propylene glycol 40mg/g For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gel. White, smooth gel. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acnecide is indicated in the management of acne vulgaris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Topical administration only. Adults and children: After washing with a mild cleanser and water, apply once or twice daily or as directed to the affected areas. The degree of drying and peeling can be adjus Lesen Sie das vollständige Dokument