Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
PERINDOPRIL TERT-BUTYLAMINE SALT
Les Laboratoires Servier
PERINDOPRIL TERT-BUTYLAMINE SALT
2 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Withdrawn
2013-08-27
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0568/017/001 Case No: 2062163 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to LES LABORATOIRES SERVIER 22, RUE GARNIER, 92200 NEUILLY-SUR-SEINE, FRANCE an authorisation, subject to the provisions of the said Regulations, in respect of the product PERINDOPRIL TERT-BUTYLAMINE 2MG TABLETS 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 28/04/2009 until 13/11/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/04/2009_ _CRN 2062163_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Perindopril tert-butylamine 2mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Perindopril tert-butylamine. One tablet contains 1.669 mg perindopril corresponding to 2 mg perindopril tert-butylamine. Excipient: lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, round tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension: Treatment of hypertension Heart Failure: Treatment of symptomatic heart failure Stable coronary artery disease: Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation. 4.2 POS Pročitajte cijeli dokument