מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
SODIUM AUROTHIOMALATE
May & Baker Limited
50mg/0.5 Millilitre
Solution for Injection
1983-04-01
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0040/068/005 Case No: 2030701 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to MAY & BAKER LIMITED RPR HOUSE, 50 KINGS HILL AVENUE, WEST MALLING, KENT ME19 4AH, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product MYOCRISIN INJECTION 50 MG (10% W/V) 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 31/01/2007 until 31/03/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 01/02/2007_ _CRN 2030701_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Myocrisin Injection 50mg (10%w/v) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium Aurothiomalate, 50 mg in 0.5 ml. For excipients see 6.1. 3 PHARMACEUTICAL FORM Solution for Injection A pale yellow aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For use in the management of active progressive rheumatoid arthritis, including progressive juvenile rheumatoid arthritis especially if polyarticular or sero-positive. In some cases of chronic discoid lupus erythematosus unresponsive to anti-malarials a response may be obtained with this drug. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Myocri קרא את המסמך השלם