Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
SIMVASTATIN
Laboratoires Irex - Groupe Sanofi-Synthelabo
5 Milligram
Film Coated Tablet
2007-05-04
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA1190/001/001 Case No: 2003260 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to LABORATOIRES IREX - GROUPE SANOFI-SYNTHELABO 22 AVENUE GALILEE, 92355 LE PLESSIS ROBINSON, FRANCE an authorisation, subject to the provisions of the said Regulations, in respect of the product SIMVASTATIN IREX 5 MILLIGRAM 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 04/05/2007 until 03/05/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/05/2007_ _CRN 2003260_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Simvastatin Irex 5mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg of simvastatin. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Oblong, biconvex, yellow tablets with a scoreline on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolaemia Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate. Treatment of homozygous familial hypercholesterolaemia a Lugege kogu dokumenti