Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
PERINDOPRIL ERBUMINE
Teva Pharma B.V.
8 Milligram
Tablets
2008-05-16
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0749/058/002 Case No: 2072857 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to TEVA PHARMA B.V. COMPUTERWEG 10, 3542 DR UTRECHT, NETHERLANDS an authorisation, subject to the provisions of the said Regulations, in respect of the product TEVARYL 8 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 23/07/2010 until 15/05/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 23/07/2010_ _CRN 2072857_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tevaryl 8 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains perindopril tert-butylamine 8 mg, equivalent to 6.676 mg perindopril. Excipients: each tablet contains 110.00 mg of lactose. For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Tablet White, round, uncoated, biconvex tablets with ‘P8’ engraved on one side of the tablet and the other side plain. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Treatment of hypertension Heart Failure Treatment of symptomatic heart failure Stable coronary artery disease: Reduction of risk of cardiac events in patients with a history of myocardial infarction Läs hela dokumentet