Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
PERINDOPRIL TERT-BUTYLAMINE INDAPAMIDE
PCO Manufacturing
4/1.25 Milligram
Tablets
2007-08-03
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA0465/067/003 Case No: 2054664 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PCO MANUFACTURING LIMITED UNIT 10, ASHBOURNE BUSINESS PARK, RATH, ASHBOURNE, CO. MEATH, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product COVERSYL PLUS 4MG/1.25MG 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 20/10/2008 until 02/08/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 20/10/2008_ _CRN 2054664_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Coversyl Plus 4mg/1.25mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains: Perindopril tert-butylamine 4.00 mg, equivalent to 3.338 mg perindopril Indapamide 1.25 mg Excipients: Lactose Monohydrate For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Tablet. _Product imported from the Netherlands:_ White, rod-shaped tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension, COVERSYL PLUS 4mg/1.25mg Tablets are indicated in patients whose blood pressure is not adequately controlled on perindopril alone 4.2 POSOLOGY AND ME Lugege kogu dokumenti