Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
AMLODIPINE
Ergha Healthcare Ltd
10mg Milligram
Tablets
2007-01-12
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0966/010/002 Case No: 2086528 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ERGHA HEALTHCARE LTD DAMASTOWN, MULHUDDART, DUBLIN 15, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product RUSTIN 10 MG TABLETS the particulars of which are set out in 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 28/07/2010 until 11/01/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/07/2010_ _CRN 2086528_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT RUSTIN 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Amlodipine Besilate equivalent to 10 mg Amlodipine. For full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Tablet White, round, slightly arched tablets, with “AB 10” and breakline on one side and plain on the other. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. In the management of essential hypertension and be used as the sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive may benefit from the addition of Rustin, which h Прочитайте повний документ