Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FLUVASTATIN SODIUM
Teva Pharma B.V.
40 Milligram
Capsule
2008-07-25
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0749/043/002 Case No: 2076636 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 FLUVASTATIN TEVA 40 MG CAPSULES 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 09/04/2010 until 24/07/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/04/2010_ _CRN 2076636_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fluvastatin Teva 40 mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One 40 mg capsule contains 40 mg fluvastatin (as fluvastatin sodium). Excipient: 199.2 mg lactose monohydrate/capsule For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard The 40 mg capsules have a yellow opaque body and pink opaque cap marked 93/7443, and are filled with an off-white to yellowish powder with small agglomerates. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fluvastatin is indicated as an adjunct to diet for the reduction of elevated total cholesterol (total-C) and low-density lipoprotein ch Read the complete document