Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
BISOPROLOL FUMARATE
B & S Healthcare
BISOPROLOL FUMARATE
10 Milligram
Tablets
Withdrawn
2011-09-07
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PPA1328/013/005 Case No: 2034068 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 CARDICOR 10 MILLIGRAM 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 26/03/2007 until 05/10/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/04/2007_ _CRN 2034068_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cardicor 10 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg bisoprolol fumarate. (2:1) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from Italy and the UK:_ Light orange, heart shaped, film-coated tablet, scored on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of stable chronic moderate to severe heart failure with reduced systolic ventricular function (ejection fraction ≤35%, based on echocardiography) in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides (for a Prečítajte si celý dokument