País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
LISINOPRIL DIHYDRATE
Profind Wholesale Ltd.
5 Milligram
Tablets
2009-05-28
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PPA1500/018/001 Case No: 2083742 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PROFIND WHOLESALE LTD. UNIT 625, KILSHANE AVENUE, NORTHWEST BUSINESS PARK, DUBLIN 15, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product ZESTRIL 5MG TABLETS 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 28/07/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/07/2010_ _CRN 2083742_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zestril 5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Lisinopril dihydrate equivalent to 5mg anhydrous lisinopril For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets _Product imported from _the UK: Pink, round, biconvex tablets marked with a heart shape and 5 on one side a break bar on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPERTENSION Treatment of hypertension. HEART FAILURE Treatment of symptomatic heart failure. ACUTE MYOCARDIAL INFARCTION Short-term (6 weeks) treatment of haemodynamically stable patients within 24 hours of an acute myocardial infarction. RE Leer el documento completo