Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CARVEDILOL
Niche Generics Limited
12.5 Milligram
Tablets
2003-08-22
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1063/003/003 Case No: 2067236 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to NICHE GENERICS LIMITED 1, THE CAM CENTRE, WILBURY WAY, HITCHIN, HERTFORDSHIRE SG4 OTW, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product BIOCARD 12.5 MG 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 19/03/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 23/03/2010_ _CRN 2067236_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Biocard 12.5 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 12.5 mg carvedilol. Excipients: Each tablet contains 144.50 mg lactose monohydrate and 10 mg sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets. Appearance: Oval slightly biconvex, white tablet, marked S3 on one side, scored on the reverse. The tablets can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _SYMPTOMATIC CHRONIC HEART FAILURE (CHF)_ Biocard is indicated for the treatment of symptomatic CHF (New York Heart Association (NYHA) Classes II Read the complete document