Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
CLOBETASOL PROPIONATE
Galderma (UK) Ltd
500 Micrograms/g
Cutaneous Emulsion
2005-11-11
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0590/022/001 Case No: 2033593 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 ETRIVEX 500 MICROGRAMS/G CUTANEOUS EMULSION 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 02/08/2007 until . Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 03/08/2007_ _CRN 2033593_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Etrivex 500 micrograms/g cutaneous emulsion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of cutaneous emulsion contains 500 micrograms of clobetasol propionate. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous emulsion White, fluid emulsion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Topical treatment of moderate to severe plaque-type psoriasis in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For cutaneous use. Etrivex 500 micrograms/g cutaneous emulsion should be applied in thin layer without occlusion to the psoriasis affected areas not more than twice per day. It should b Lue koko asiakirja