Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
HYDROCORTISONE BUTYRATE CHLORQUINALDOL
Astellas Pharma Co. Ltd
0.1/3.0 %w/w
Ointment
2005-09-30
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1241/004/002 Case No: 2036420 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ASTELLAS PHARMA CO. LTD 25 THE COURTYARD, KILCARBERY BUSINESS PARK, CLONDALKIN, DUBLIN 22, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product LOCOID C OINTMENT 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 14/10/2007. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 23/10/2007_ _CRN 2036420_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Locoid C Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The ointment contains Hydrocortisone butyrate 0.1% w/w and Chlorquinaldol 3.0% w/w. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ointment Buff coloured, translucent soft fatty ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The product is recommended for clinical use in treatment of conditions responsive to topical corticosteroids, e.g. eczema, dermatitis and psoriasis where there is concurrent infection by a micro-organism susceptible to chlorquinaldol, or where such infection is to be prevented. Topical corticosteroi Read the complete document