देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
ASCORBIC ACID, SILICON COATED
Ricesteele Manufacturing Ltd
100 mg Milligram
Tablets
1988-05-18
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0095/008/004 Case No: 2045922 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to RICESTEELE MANUFACTURING LTD COOKSTOWN INDUSTRIAL ESTATE, TALLAGHT, DUBLIN 24, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product RUBEX 100 MG TABLETS 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 18/05/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/06/2008_ _CRN 2045922_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rubex 100 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Ascorbic Acid 100 mg. Each tablet also contains Sucrose 215mg. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. White, flat, circular tablets about 10.3mm in diameter, with bevelled edges and scored on one face. The scoreline allows the tablet to be broken for ease of swallowing only. It does not divide the tablet into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis and treatment of ascorbic acid deficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: Up to 1000mg daily o पूरा दस्तावेज़ पढ़ें