국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
ISOSORBIDE MONONITRATE
Ethypharm
ISOSORBIDE MONONITRATE
20 Milligram
Prolonged Release Capsules
Product subject to prescription which may be renewed (B)
Withdrawn
2012-03-16
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0549/003/001 Case No: 2043622 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ETHYPHARM SA 17-21 RUE ST. MATTHIEU, 78550 HOUDAN, FRANCE an authorisation, subject to the provisions of the said Regulations, in respect of the product CARDOX SR 20 MG. PROLONGED-RELEASE CAPSULES. 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 22/04/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 23/04/2008_ _CRN 2043622_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cardox SR 20mg Prolonged-release Capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains: Isosorbide mononitrate 20.00 mg. Excipients: also includes lactose monohydrate 60mg per capsule and sucrose 19.25mg per capsule. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release Capsules, hard. (Prolonged-release capsule). Size 3, opaque white, hard gelatin capsules contains spherical off-white microganules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prophylaxis of angina pectoris and as an adjunct for the treatment of chronic heart failure. 4.2 POSOLOGY AND METHOD OF 전체 문서 읽기