Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
QUINAPRIL HYDROCHLORIDE
Ranbaxy Ireland Limited
5 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) PA0408/068/001 Case No: 2053491 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 5 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 30/10/2008 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 30/10/2008_ _CRN 2053491_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Quinapril Ranbaxy 5mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains _5_mg 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 “5” 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 adm Read the complete document