Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
PERINDOPRIL ARGININE
S.C.A.C Limited
10 Milligram
Film Coated Tablet
2010-01-11
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1593/001/002 Case No: 2069251 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to S.C.A.C LIMITED CYGNET HOUSE, MARKET SQUARE, STAINES, MIDDLESEX TW18 4RH, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product COVERSYL ARGININE 10MG FILM-COATED 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 11/01/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 11/01/2010_ _CRN 2069251_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Coversyl Arginine 10mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 6.790mg perindopril corresponding to 10mg perindopril arginine. Excipients: Also contains lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet. _Product imported from _Poland: Green, round, biconvex, film-coated tablet engraved with on one face and the Servier logo on the other face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension: Treatment of hypertension. Stable coronary artery disease: Reduction of risk of cardiac read_full_document