देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
PRAVASTATIN SODIUM
Alfred E Tiefenbacher (GmbH & Co. KG)
PRAVASTATIN SODIUM
40 Milligram
Tablets
Withdrawn
2009-02-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1178/001/003 Case No: 2049397 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ALFRED E TIEFENBACHER VAN-DER-SMISSEN-STRASSE 1, 22767 HAMBURG, GERMANY an authorisation, subject to the provisions of the said Regulations, in respect of the product VASTATIFIX 40 MG FILM-COATED 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 13/06/2008 until 28/10/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 14/06/2008_ _CRN 2049397_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vastatifix 40 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40 mg pravastatin sodium. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Yellow, indented capsule shape tablet, with "40" on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolemia Treatment of primary hypercholesterolemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate. Primary prevention Reduction of cardiovascular mortality and morbidity in patients wi पूरा दस्तावेज़ पढ़ें