Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
DIMETICONE ZINC OXIDE CALAMINE
Forest Laboratories UK Ltd
Cream
2001-10-15
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0100/044/001 Case No: 2071722 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to FOREST LABORATORIES UK LTD RIVERBRIDGE HOUSE, CROSSWAYS BUSINESS P, KENT, DA2 6SL, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product VASOGEN CREAM (DIMETICONE 20% W/W, ZINC OXIDE 7.5% W/W AND CALAMINE 1.5% 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 25/09/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 25/09/2009_ _CRN 2071722_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vasogen Cream (Dimeticone 20% w/w, zinc oxide 7.5 % w/w and calamine 1.5% w/w) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream A pale pink cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For use as a barrier cream where protection from water, irritants or body exudates is needed in conditions such as nappy rash, bedsores and for local protection of the skin around the stoma after ileostomy and colostomy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical use. A Прочитайте повний документ