Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
ALUMINIUM HYDROXIDE GEL, DRIED MAGNESIUM CARBONATE LIGHT ALGINIC ACID SILICA COLLOIDAL HYDRATED
Pierre Fabre Medicament
ALUMINIUM HYDROXIDE GEL, DRIED MAGNESIUM CARBONATE LIGHT ALGINIC ACID SILICA COLLOIDAL HYDRATED
30/40/200/ Milligram
Tablets Chewable
Product not subject to medical prescription
Withdrawn
2013-05-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0329/002/001 Case No: 2061404 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PIERRE FABRE MEDICAMENT 45 PLACE ABEL GANCE, 92100 BOULOGNE, CEDEX, FRANCE an authorisation, subject to the provisions of the said Regulations, in respect of the product TOPAAL 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 10/03/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 10/03/2009_ _CRN 2061404_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Topaal Chewable Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Excipients: Each chewable tablet contains 11mg sodium, 220mg lactose monohydrate and 880mg sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablets Round, off-white or light cream coloured, 18mm diameter, flat faced bevel-edged chewable tablet, with a score-line on one face. The score-line is only to facilitate breaking, for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the control of the symptoms of gastro-oesophageal reflux and oesophagitis associated with hiat Belgenin tamamını okuyun