Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
NIZATIDINE
Flynn Pharma Ltd
300 Milligram
Capsules Hard
2005-08-12
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1226/004/002 Case No: 2049007 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to FLYNN PHARMA LTD ALTON HOUSE, 4 HERBERT STREET, DUBLIN 2, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product AXID 300 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 13/10/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 13/10/2009_ _CRN 2049007_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Axid 300 mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 300 mg Nizatidine. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsules, hard (capsule) Hard gelatin capsules with brown caps and pale yellow bodies, coded FLYNN 3145, containing an off-white granular powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of the following diseases where reduction of gastric acid is indicated: Duodenal ulcer, Benign gastric ulcer, Prevention of duodenal or benign gastric ulcer recurrence, Gastric and/or duodenal ulcer associated with concomitant use of non-steroidal anti-inflamm Прочитайте повний документ