Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
RAMIPRIL
Sanofi-Aventis Ireland Limited
10mg Milligram
Capsules Hard
2005-05-13
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0540/137/004 Case No: 2065496 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 RAMIPRIL 10MG 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 27/10/2009 until 12/05/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 27/10/2009_ _CRN 2065496_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ramipril 10mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 10 mg ramipril For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gelatin capsules, hard. Blue opaque/white opaque gelatin capsules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ramipril is indicated in the treatment of all grades hypertension. Congestive heart failure; as adjunctive therapy to diuretics with or without cardiac glycosides. Ramipril has been shown to reduce mortality when administered to patients surviving acute myocardial infarction with clinical evidence of heart failure. Prevention of myocardial infarction, Läs hela dokumentet