Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
CALCIUM CARBONATE
SSL International plc
CALCIUM CARBONATE
800 Milligram
Tablets Chewable
Product not subject to medical prescription
Withdrawn
0000-00-00
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1138/022/002 Case No: 2067702 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to Transferred from PA0618/038/002. SSL INTERNATIONAL PLC VENUS, 1 OLD PARK LANE, TRAFFORD PARK, MANCHESTER M41 7HA, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product REMEGEL SUMMER FRUIT 800 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 08/01/2010 until 12/03/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 08/01/2010_ _CRN 2067702_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Remegel Summer Fruit 800mg Chewable Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 800mg Calcium Carbonate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablets. A pink, soft chewable square with beveled edges and rounded corners. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Remegel tablets are indicated for the relief of stomach upsets due to hyperacidity and heartburn. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of Administration: Oral. ADULTS AND CHILDREN 12 YEARS AND Baca dokumen lengkap