Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
ISOSORBIDE MONONITRATE
AstraZeneca UK Limited
ISOSORBIDE MONONITRATE
30 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Withdrawn
2010-12-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0970/041/001 Case No: 2040338 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ASTRAZENECA UK LIMITED 600 CAPABILITY GREEN, LUTON, LU1 3LU, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product IMDUR 30 MG PROLONGED-RELEASE FILM-COATED 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 24/01/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 07/03/2008_ _CRN 2040338_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Imdur 30 mg Prolonged-release Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains isosorbide mononitrate 30 mg. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release, film-coated tablet. Pink, oval, biconvex tablets scored on both sides and engraved ‘A/II’ on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylactic management of angina pectoris. Imdur is not indicated in the management of acute attacks of angina pectoris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DOSAGE Imdur 60 mg once daily, to be taken in the morning. Đọc toàn bộ tài liệu