Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LOSARTAN POTASSIUM LOSARTAN POTASSIUM
Merck Sharp and Dohme Limited
12.5 & 50 Milligram
Film Coated Tablet
1998-12-21
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0035/082/002 Case No: 2077446 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to MERCK SHARP AND DOHME LIMITED HERTFORD ROAD, HODDESDON, HERTFORDSHIRE EN11 9BU, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product COZAAR INITIATION PACK FOR HEART FAILURE 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 21/12/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/05/2010_ _CRN 2077446_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cozaar Initiation Pack for Heart Failure 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Cozaar 12.5 mg tablet contains 11.5 mg of losartan, present as 12.5mg of losartan potassium. Each Cozaar 50 mg tablet contains 45.8 mg of losartan present as 50 mg losartan potassium. Excipients: Each Cozaar 12.5 mg tablet contains 25.25 mg of lactose monohydrate. Each Cozaar 50 mg tablet contains 25.5 mg of lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet Cozaar 12.5 mg: Blue, oval-shaped, film-coated tablet marked ‘11’ on one side a Read the complete document