Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
RAMIPRIL
Imbat Limited
10 Milligram
Tablets
2008-02-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1151/051/004 Case No: 2069197 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to IMBAT LIMITED UNIT L2, NORTH RING BUSINESS PARK, SANTRY, DUBLIN 9 an authorisation, subject to the provisions of the said Regulations, in respect of the product TRITACE, 10 MILLIGRAM 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 26/08/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 04/09/2009_ _CRN 2069197_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tritace 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg of ramipril. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet _Product imported from Austria:_ White, oblong tablets with a score line on both sides engraved on one side with ‘HMO’ and plain on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tritace is indicated in the treatment of all grades of hypertension. Congestive heart failure; as adjunctive therapy to diuretics with or without cardiac glycosides. Tritace has been shown to reduce mortality when administered to patients surviving acute myocardi Прочетете целия документ