Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ATENOLOL
Imbat Limited
50 Milligram
Film Coated Tablet
2008-03-07
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PPA1151/055/002 Case No: 2083791 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 ATECOR 50MG FILM-COATED 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 31/08/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 31/08/2010_ _CRN 2083791_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atecor 50mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50mg Atenolol Excipients: lactose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet _Product imported from Germany:_ White, round, biconvex, film-coated tablet with a score line on one face and marked '50' on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a beta-adrenoceptor blocker ATECOR is indicated for the treatment of essential hypertension, angina pectoris and cardiac dysrhythmias. ATECOR is also indicated in early intervention in the acute phase of myocardial infarction and for the long-term pr Read the complete document