Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
OMEPRAZOLE
Medana Pharma SA
OMEPRAZOLE
10 Milligram
Capsule
Withdrawn
2010-08-23
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1483/001/001 Case No: 2076522 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to MEDANA PHARMA SA 10 WL.LOKIETKA STREET, 98-200 SIERADZ, POLAND an authorisation, subject to the provisions of the said Regulations, in respect of the product BENTOME, 10 MILLIGRAM 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 21/12/2009 until 31/05/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 08/01/2010_ _CRN 2076522_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bentome 10 mg capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 10 mg of Omeprazole Also contains sucrose. For a full list of excipients, see Section 6.1 3 PHARMACEUTICAL FORM Capsule hard, with gastro-resistant granules. Opaque red cap and opaque orange body, containing white to beige granules. Size 3 capsule marked with O10 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Duodenal ulcers • Benign gastric ulcers • Reflux oesophagitis • Maintenance treatment of reflux oesophagitis to prevent relapse • Zollinger-Ellison syndrome • Treatment of NSAID (Non Steroid Anti Inflammatory Drug) related gas Preberite celoten dokument