País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
AMIODARONE HYDROCHLORIDE
B & S Healthcare
200 Milligram
Tablets
2006-12-21
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1328/058/001 Case No: 2061197 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 CORDARONE X 200 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 24/02/2009 until 20/12/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 24/02/2009_ _CRN 2061197_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cordarone X 200 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg amiodarone hydrochloride. Excipients: Lactose monohydrate. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet _Product imported from France, Italy and the Netherlands:_ Round, white tablets with a breakline, on one side imprinted ‘200’ and on the other a logo. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment should be initiated and normally monitored only under hospital or specialist supervision. Oral Cordarone X is indicated for the treatment of severe rhythm Llegiu el document complet