Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
GLUCOSAMINE SULFATE
Pinewood Laboratories Ltd,
1500 Milligram
Powder for Oral Solution
2008-10-10
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0281/135/001 Case No: 2079243 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PINEWOOD LABORATORIES LTD, T/A PINEWOOD HEALTHCARE BALLYMACARBRY, CLONMEL, CO. TIPPERARY, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product OSTEOLE 1500 MG 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 14/04/2010 until 09/10/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 15/04/2010_ _CRN 2079243_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Osteole 1500 mg powder for oral solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains: Crystalline glucosamine sulfate 1884mg equivalent to glucosamine sulfate 1500mg and sodium chloride 384mg Excipients: also includes 2.5 mg of aspartame (E951), 2.028 g of sorbitol (E420) and 151 mg of sodium per sachet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution. A white to slight yellow, crystalline, odourless powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of the symptoms of osteoarthritis, i.e. Les hele dokumentet