Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
BENZOYL PEROXIDE HYDROUS
Galderma (UK) Ltd
10 %w/w
Gel
1997-10-31
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0590/007/004 Case No: 2036964 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 WASH 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 31/10/2007. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 20/11/2007_ _CRN 2036964_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Acnecide Wash 10 % w/w Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Hydrous Benzoyl Peroxide equivalent to Benzoyl peroxide 10 % w/w. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Gel. White to off white gel. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acnecide Wash is intended for the cutaneous treatment of acne vulgaris of the face, chest and back, where comedones, papules predominate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For cutaneous (topical) administration only. Unless otherwise directed, Acnecide Wash should be applied once daily to cover the affected skin ar Læs hele dokumentet