Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
GLUCOSAMINE SULFATE SODIUM CHLORIDE
B & S Healthcare
1500 Milligram
Powder for Oral Solution
2010-02-12
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1328/133/001 Case No: 2074339 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to B & S HEALTHCARE UNIT 4, BRADFIELD ROAD, RUISLIP, MIDDLESEX, HA4 0NU, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product DONA 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 12/02/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/02/2010_ _CRN 2074339_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dona 1500mg Powder for Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains Crystalline glucosamine sulfate 1884mg equivalent to : glucosamine sulfate 1500mg sodium chloride 384mg Excipients: contains aspartame (E951) and sorbitol (E420) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for Oral Solution _Product imported from the Italy_ A white, crystalline, odourless powder 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of the symptoms of osteoarthritis, i.e. pain and function limitation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND THE Läs hela dokumentet