Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
GLUCOSAMINE SULPHATE SODIUM CHLORIDE
Clonmel Healthcare Ltd
1500 Base Milligrams
Powder for Oral Solution
2009-11-13
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0126/149/004 Case No: 2078176 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to CLONMEL HEALTHCARE LIMITED WATERFORD ROAD, CLONMEL, CO. TIPPERARY, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product ARTHRIMEL ONCE DAILY 1500MG POWDER FOR ORAL SOLUTION 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 25/05/2010 until 12/11/2014. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 25/05/2010_ _CRN 2078176_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Arthrimel Once Daily 1500mg Powder for Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 1884 mg of glucosamine sulfate and sodium chloride equivalent to 1500 mg of glucosamine sulfate and 384 mg of sodium chloride or to 1178 mg glucosamine. Excipients: Each sachet contains 2.5 mg aspartame, 2,023.5 mg sorbitol and 6.57 mmol (or 151 mg) sodium. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder for oral solution. Off-white to yellowish homogeneous powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Relief of symptoms in m Lesen Sie das vollständige Dokument