Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
RABEPRAZOLE SODIUM
Laboratorios LICONSA, S.A.
20 Milligram
Tablets Gastro-Resistant
2009-09-11
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1239/005/002 Case No: 2050096 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to LABORATORIOS LICONSA, S.A. GRAN VIA CARLOS III, 98, 7TH FLOOR, E-08028 BARCELONA, SPAIN an authorisation, subject to the provisions of the said Regulations, in respect of the product RABEPRAZOLE LICONSA 20 MG GASTRO-RESISTANT 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 11/09/2009 until 10/09/2014. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 14/09/2009_ _CRN 2050096_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rabeprazole Liconsa 20 mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 20 mg rabeprazole sodium, equivalent to 18.85 mg of rabeprazole. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet. Yellow, film-coated, biconvex tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rabeprazole Liconsa gastro-resistant tablets are indicated for treatment of: Active duodenal ulcer Active benign gastric ulcer Symptomatic erosive or ulcerative gastro-oesophageal reflux disease (GORD) Gastro-oe Lestu allt skjalið