Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
RAMIPRIL
Ranbaxy (UK) Limited
1.25 Milligram
Capsules Hard
2007-07-27
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0967/006/001 Case No: 2064661 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to RANBAXY (UK) LIMITED 20 BALDERTON STREET, LONDON W1K 6TL, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product BELLRAMIL, 1.25 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 19/05/2009 until 26/07/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 19/05/2009_ _CRN 2064661_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bellramil 1.25 mg Capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains ramipril 1.25 mg. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsule, hard, Size 4 with yellow cap/white body imprinted with ‘R’ on cap and ‘1.25’ on body. Contains white to off- white granular powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For reducing the risk of myocardial infarction, stroke, cardiovascular death or need for revascularisation procedures in patients of 55 years or more who have clinical evidence of cardiovascular disease (previous MI, unstable Soma hati kamili