Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
HYDROTALCITE
Bayer Limited
HYDROTALCITE
500 Milligram
Tablets Chewable
Withdrawn
2009-03-27
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1410/033/001 Case No: 2056854 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to Transferred from PA0021/047/001. BAYER LIMITED THE ATRIUM, BLACKTHORN ROAD, DUBLIN 18, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product ALKA ANTACID 500 MG 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 24/10/2008 until 25/05/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/10/2008_ _CRN 2056854_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alka Antacid 500mg Chewable Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains hydrotalcite 500 mg. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablets. White round tablets with peppermint-like odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic relief in the following conditions: indigestion; hyperacidity; dyspepsia; gastric and duodenal ulceration; gastritis; heartburn, especially when associated with reflux oesophagitis or hiatus hernia and heartburn in pregnancy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND THE ELDERLY O Lees het volledige document