מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
OMEPRAZOLE
acis Arzneimittel GmbH
40 Milligram
Capsules Hard
2008-04-25
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1486/001/003 Case No: 2072945 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ACIS ARZNEIMITTEL GMBH LIL - DAGOVER - RING 7, 82031 GRUNWALD, GERMANY an authorisation, subject to the provisions of the said Regulations, in respect of the product LEMOWAN, 40 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 04/12/2009 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 04/12/2009_ _CRN 2072945_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lemowan 40 mg capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 40 mg of Omeprazole Also contains sucrose For a full list of excipients, see Section 6.1 3 PHARMACEUTICAL FORM Capsules, hard, with gastro-resistant granules. Opaque blue cap and opaque orange body, containing white to beige granules. Size 0 capsule. 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 gastric קרא את המסמך השלם