Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
MACROGOL/POLYETHYLENE GLYCOL 3350 SODIUM CHLORIDE
Profind Wholesale Ltd.
13.8 Grams
Powder for Oral Solution
2009-08-28
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PPA1500/026/001 Case No: 2083742 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PROFIND WHOLESALE LTD. UNIT 625, KILSHANE AVENUE, NORTHWEST BUSINESS PARK, DUBLIN 15, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product MOVICOL 13.8G SACHET, POWDER FOR ORAL SOLUTION the particulars of which are set out in 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 28/07/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/07/2010_ _CRN 2083742_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Movicol 13.8g sachet, Powder for oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of Movicol contains the following active ingredients: Macrogol 3350 13.125g Sodium Chloride 350.7mg Sodium bicarbonate 178.5mg Potassium chloride 46.6mg The content of electrolyte ions per sachet when made up to 125ml of solution is as follows: Sodium 65 mmol/l Chloride 53 mmol/l Potassium 5.4 mmol/l Bicarbonate 17 mmol/l For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder for oral solution _Product imported from the UK_ Free flowing white powder 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aqra d-dokument sħiħ