Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PADIMATE O AVOBENZONE ETHYLHEXYL P-METHOXYCINNAMATE
Stiefel Laboratories (U.K.) Ltd.
Cutaneous Solution
2002-12-06
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0144/043/001 Case No: 2044218 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to STIEFEL LABS (U.K.) LTD. HOLTSPUR LANE, WOOBURN GREEN, HIGH WYCOMBE, BUCKS HP10 0AU, ENGLAND an authorisation, subject to the provisions of the said Regulations, in respect of the product STIEFEL SUNBLOCK LOTION PADIMATE O 8.0% W/W AVOBENZONE 2.0% W/W OCTYL METHOXYCINNAMATE 10.0% W/W 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 06/12/2007. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 01/05/2009_ _CRN 2044218_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Stiefel Sunblock Lotion Padimate O 8.0% w/w Avobenzone 2.0% w/w Octyl Methoxycinnamate 10.0% w/w 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Excipients: Also contains Sorbic acid 0.3% w/w and Miglyol 840 Gel B 4% w/w. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Cutaneous emulsion 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS STIEFEL SUNBLOCK LOTION is indicated as a protective Sunblock in patients with photodermatoses, including those caused by radiotherapy. It is effective in protecting against UVA and UVB ra Read the complete document