Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
MAGALDRATE ALGINIC ACID SODIUM BICARBONATE
Forest Laboratories UK Ltd
MAGALDRATE ALGINIC ACID SODIUM BICARBONATE
400/200/100 Milligram
Tablets Chewable
Product not subject to medical prescription
Withdrawn
2011-03-31
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0100/048/001 Case No: 2072941 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, ANCHOR BOULEVARD, CROSSWAYS BUSINESS PARK, DARTFORD, KENT DA2 6SL, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product BISODOL HEARTBURN CHEWABLE TABLETS 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 19/01/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 24/01/2010_ _CRN 2072941_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bisodol Heartburn Chewable Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Excipients: Each tablet contains 0.8g sucrose and 27mg sodium. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablet Round, white, smooth, bevel-edged edge tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of heartburn, including heartburn of pregnancy, reflux oesophagitis, hiatus hernia, regurgitation and all cases of epigastric distress associated with gastric reflux. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. Adults, Olvassa el a teljes dokumentumot