Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
NIFEDIPINE
Profind Wholesale Ltd
NIFEDIPINE
30 Milligram
Tablet Prolonged Release
Product subject to prescription which may be renewed (B)
Withdrawn
2013-03-05
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PPA1500/037/002 Case No: 2083758 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PROFIND WHOLESALE LTD. UNIT 625, KILSHANE AVENUE, NORTHWEST BUSINESS PARK, DUBLIN 15, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product ADALAT LA 30 MG PROLONGED-RELEASE TABLET 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 28/07/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/07/2010_ _CRN 2083758_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adalat LA 30 mg Prolonged-Release Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 30mg nifedipine. Excipients: Sodium For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release film coated tablet _Product imported from Italy_ Pink, circular convex tablets with Adalat 30 marked on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of all grades of hypertension. For the management of chronic stable angina pectoris either as monotherapy or in combination with a beta-blocker. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration, the ta Lesen Sie das vollständige Dokument