البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
TACALCITOL
Crookes Healthcare Ltd
4 Microgram
Cutaneous Emulsion
2005-12-02
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0043/027/002 Case No: 2042784 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to CROOKES HEALTHCARE LTD 1 THANE ROAD WEST, NOTTINGHAM, NG2 3AA, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product CURATODERM 4 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 18/09/2008 until 01/12/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 03/10/2008_ _CRN 2042784_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Curatoderm 4 micrograms/g Cutaneous Emulsion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each g of emulsion contains 4.17 micrograms tacalcitol monohydrate equivalent to 4 micrograms tacalcitol. Excipients: propylene glycol, dodecyl gallate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous emulsion White, thin emulsion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Topical treatment of mild to moderate psoriasis, especially on the scalp. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cutaneous emulsion. Children (< 12 years): The use of Curatoderm Emulsion in childr اقرأ الوثيقة كاملة