Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
RAMIPRIL
Sanofi-Aventis Ireland Limited T/A SANOFI
RAMIPRIL
5mg Milligram
Capsule
Withdrawn
2009-03-07
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0540/084/003 Case No: 2060254 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to SANOFI-AVENTIS IRELAND LIMITED CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product TRITACE 5MG CAPSULES 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 03/02/2009 until 07/03/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 03/02/2009_ _CRN 2060254_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tritace 5 mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 5.0 mg ramipril. For excipients, see 6.1 3 PHARMACEUTICAL FORM Gelatin capsule, hard. Scarlet opaque/white opaque gelatin capsule, containing a white powder mixture. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tritace is indicated in the treatment of all grades 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 myocardial infarction with clinical evidence of heart failure. Non-diabet Przeczytaj cały dokument