Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
SODIUM HYDROGEN CARBONATE MAGNESIUM CARBONATE LIGHT MAGNESIUM CARBONATE HEAVY
Forest Laboratories UK Ltd
Powder for Oral Suspension
1983-04-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0100/047/003 Case No: 2071722 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to FOREST LABORATORIES UK LTD RIVERBRIDGE HOUSE, CROSSWAYS BUSINESS P, KENT, DA2 6SL, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product BISODOL ANTACID POWDER FOR ORAL SUSPENSION MAGNESIUM CARBONATE, HEAVY 18 MG MAGNESIUM CARBONATE, LIGHT 345MG SODIUM HYDROGEN CARBONATE 532/5ML 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 25/09/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 25/09/2009_ _CRN 2071722_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bisodol Antacid Powder for Oral Suspension Magnesium carbonate, heavy 18 mg Magnesium carbonate, light 345 mg Sodium hydrogen carbonate 532 mg/5 ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml (0.9g) of powder contains: 18 mg Magnesium carbonate, heavy 345 mg Magnesium carbonate, light 532mg Sodium hydrogen carbonate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral suspension A white powder with a slight odour and a taste of peppermint, for d Přečtěte si celý dokument