Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ROSUVASTATIN (AS CALCIUM)
B & S Healthcare
40 Milligram
Film Coated Tablet
2010-08-13
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PPA1328/059/004 Case No: 2083385 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to B & S HEALTHCARE UNIT 4, BRADFIELD ROAD, RUISLIP, MIDDLESEX, HA4 0NU, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product CRESTOR 40 MG FILM-COATED 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 13/08/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 17/08/2010_ _CRN 2083385_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Crestor 40mg film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40mg rosuvastatin (as rosuvastatin calcium). Each tablet also contains 168.32mg of lactose monohydrate. For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from UK_: Film-coated tablets, pink, oval and marked with 'ZD4522' on one side and '40' on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TREATMENT OF HYPERCHOLESTEROLAEMIA Adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterola Read the complete document