Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
ESOMEPRAZOLE
McDowell Pharmaceuticals
20 Milligram
Tablets Gastro-Resistant
2009-01-30
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1473/001/001 Case No: 2050120 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to MCDOWELL PHARMACEUTICALS 4 ALTONA ROAD, LISBURN, N. IRELAND, BT27 5QB an authorisation, subject to the provisions of the said Regulations, in respect of the product NEXIUM 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 30/01/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 30/01/2009_ _CRN 2050120_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nexium 20 mg Gastro-Resistant Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 20mg esomeprazole (as magnesium trihydrate). Excipients: Sucrose (contained in sugar spheres) For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Gastro-resistant tablet. _Product imported from the UK:_ Light Pink, oblong, biconvex, tablet engraved ‘20 mg’ on one side and ‘A/EH’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NEXIUM tablets are indicated for: GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) treatment of erosive reflux oesophagitis long-term management of p Citiți documentul complet