Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
SIMVASTATIN
Ratiopharm GmbH
5 Milligram
Coated Tablets
2001-10-19
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0819/028/001 Case No: 2056263 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to RATIOPHARM GMBH GRAF-ARCO-STRASSE 3, D-89079 ULM, GERMANY an authorisation, subject to the provisions of the said Regulations, in respect of the product SIMVASTATIN SH, 5 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 12/12/2008 until 15/07/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/12/2008_ _CRN 2056263_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Simvastatin SH 5 mg Film-coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of simvastatin. Each tablet contains 79.5 mg lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Oblong, biconvex, yellow tablets with a score line on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 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- Izlasiet visu dokumentu