País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
CLIOQUINOL HYDROCORTISONE
Novartis Consumer Health UK Limited
CLIOQUINOL HYDROCORTISONE
3/1 %w/w %w/w
Cream
Product subject to prescription which may be renewed (B)
Withdrawn
2009-05-29
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0030/015/001 Case No: 2045318 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to NOVARTIS CONSUMER HEALTH UK LTD WIMBLEHURST ROAD, HORSHAM, WEST SUSSEX RH12 5AB, ENGLAND an authorisation, subject to the provisions of the said Regulations, in respect of the product VIOFORM HYDROCORTISONE 3/1 % W/W CREAM 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 12/05/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 30/01/2009_ _CRN 2045318_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vioform Hydrocortisone 3/1 % w/w Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Clioquinol 3% w/w Hydrocortisone 1% w/w Also contains Cetostearyl alcohol For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Cream A white to faintly yellow, homogenous cream with a characteristic odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Exudative and secondarily infected eczema and dermatitis, including atopic eczema, primary irritant dermatitis, allergic and seborrhoeic dermatitis. Infected insect bite reactions. Genital or peri-anal intertrigo. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Met Leia o documento completo