国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
TRANDOLAPRIL
Abbott Laboratories Ireland Ltd
TRANDOLAPRIL
1.0 Milligram
Capsules Hard
Product subject to prescription which may be renewed (B)
Withdrawn
2010-06-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0038/084/002 Case No: 2066860 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ABBOTT LABORATORIES IRELAND LTD 4051 KINGSWOOD DRIVE, CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product GOPTEN 1.0 MG HARD 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 17/12/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 24/12/2009_ _CRN 2066860_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gopten 1.0 mg Hard Capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains Trandolapril 1.0 mg. Excipients: also includes Lactose monohydrate 55.5 mg per capsule. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Hard Capsule. Size 4, hard gelatin capsules with an opaque red body and an opaque orange cap, containing a practically white granular mass. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPERTENSION All grades of essential hypertension. Gopten may be used alone or in combination with other antihypertensive agents. LEFT VENTRICULAR DYSFUNCTION AFTER MY 阅读完整的文件