Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
OMEPRAZOLE
Hennig Arzneimittel GmbH & Co KG
OMEPRAZOLE
10 Milligram
Capsule
Withdrawn
2008-12-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1238/002/001 Case No: 2046532 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to Transferred from PA1284/009/001. HENNIG ARZNEIMITTEL GMBH & CO KG LIEBIGSTRASSE 1-2, 65439 FLöRSHEIM AM MAIN, GERMANY an authorisation, subject to the provisions of the said Regulations, in respect of the product TUMELIN 10 MG CAPSULES 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 22/02/2008 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 06/03/2008_ _CRN 2046532_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tumelin 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 Read the complete document