Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CANDESARTAN CILEXETIL
AstraZeneca UK Limited
2 Milligram
Tablets
2002-04-29
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0970/030/001 Case No: 2078949 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ASTRAZENECA UK LIMITED 600 CAPABILITY GREEN, LUTON, LU1 3LU, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product ATACAND 2 MG TABLETS 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 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 12/05/2010_ _CRN 2078949_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atacand 2 mg tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg candesartan cilexetil. Each 2 mg tablet contains 95. 4 mg lactose monohydrate. For a full list of excipients, _see section 6.1._ 3 PHARMACEUTICAL FORM Tablet Atacand 2 mg are round (diameter 7 mm), white tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Essential hypertension. Treatment of patients with heart failure and impaired left ventricle systolic function (left ventricular ejection fraction 40%) as add-on therapy to ACE inhibitors or when ACE inhibitors are not tolerated _(see section 5.1 Pharmacodynamic_ _properties)._ 4.2 Read the complete document