Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
LANSOPRAZOLE
Norton Waterford
LANSOPRAZOLE
15 Milligram
Capsules Gastro-Resistant
Product subject to prescription which may be renewed (B)
Withdrawn
0000-00-00
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0436/041/001 Case No: 2072581 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to NORTON WATERFORD T/A IVAX PHARMACEUTICALS IRELAND, UNIT 301, IDA INDUSTRIAL PARK, CORK ROAD, WATERFORD, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product LANZIOP 15MG GASTRO-RESISTANT CAPSULES the particulars of which are set out in 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 18/08/2010 until 10/11/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/08/2010_ _CRN 2072581_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lanziop 15mg Gastro-resistant Capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 15 mg of lansoprazole. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsule, hard. White gelatin gastro-resistant capsule, filled with white to light brown or lightly pink coloured enteric-coated pellets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS o Treatment of duodenal or gastric ulcers, verified by endoscopy or radiography. o Treatment of reflux oesophagitis. o Long-term prophylaxis of reflux oesophagitis. o Zollinger-Ellison syndrome. 4.2 POSOLOGY AND METHOD OF Przeczytaj cały dokument