Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
OMEPRAZOLE MAGNESIUM
G & A Licensing Limited
10 Milligram
Tablets Gastro-Resistant
2008-11-21
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1447/018/001 Case No: 2075043 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to G & A LICENSING LTD BALLYMURRAY, CO. ROSCOMMON, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product LOSEC MUPS 10MG 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 29/01/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 02/02/2010_ _CRN 2075043_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Losec MUPS 10mg Gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10.3mg omeprazole magnesium equivalent to 10mg omeprazole. Excipients: Sugar Spheres (contain sucrose) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant, film-coated tablet. _Imported product from Belgium and the UK_ Light-pink, oblong, biconvex, gastro-resistant, film-coated tablets engraved with a logo marking on one side and 10 mg on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of oesophageal reflux disease, including reflux oesophagitis. Treatment of duodenal and beni Přečtěte si celý dokument