País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
OMEPRAZOLE MAGNESIUM
McDowell Pharmaceuticals
20 Milligram
Tablets Gastro-Resistant
2009-06-25
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1473/019/001 Case No: 2059696 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 LOSEC MUPS GASTRO-RESISTANT TABLETS 20MG 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 25/06/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/06/2009_ _CRN 2059696_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Losec Mups Gastro-Resistant Tablets 20mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20.6mg omeprazole magnesium equivalent to 20 mg omeprazole, as coated pellets. Excipient: Sucrose (contained in sugar spheres) For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant, film-coated tablet _Product imported from the UK_ Pink, oblong, biconvex, gastro-resistant, film-coated tablets engraved with on one side and 20 mg on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of oesophageal reflux disease, including reflux oesophagitis. Treatment of duodenal and Leia o documento completo