Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
QUINAPRIL HYDROCHLORIDE
Ranbaxy Ireland Limited
40 Milligram
Film Coated Tablet
2008-08-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0408/068/004 Case No: 2046050 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to RANBAXY IRELAND LIMITED SPAFIELD, CORK ROAD, CASHEL, CO. TIPPERARY, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product QUINAPRIL RANBAXY 40 MG 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 01/08/2008 until 31/07/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/08/2008_ _CRN 2046050_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Quinapril Ranbaxy 40mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40mg quinapril (as hydrochloride). For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. White to off-white oval tablets with a film coating. The codes “Q” and “40” are imprinted on one face of the tablet on either side of the break line. The other face of tablet also has a break line. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Essential hypertension and decompensated heart failure. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral a Lesen Sie das vollständige Dokument