Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
PROPAFENONE HYDROCHLORIDE
Abbott Laboratories Ireland Ltd
300 Milligram
Film Coated Tablet
1998-07-20
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0038/079/003 Case No: 2076590 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ABBOTT LABORATORIES IRELAND LTD 4051 KINGSWOOD DRIVE, CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product ARYTHMOL 300MG 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 24/02/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 25/06/2010_ _CRN 2076590_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Arythmol 300 mg Film-coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300 mg propafenone hydrochloride. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. White, biconvex, film-coated tablets and embossed “300” on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic supraventricular tachyarrhythmias warranting treatment, such as AV junctional tachycardias, supraventricular tachycardias in patients with WPW syndrome or paroxysmal atrial fibrillation. Serious symptomatic ventricular tachyarrhythmias if life-threatening or necessitating treatment Đọc toàn bộ tài liệu