Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
FELODIPINE
Selana Healthcare Ltd
5 Milligram
Tablet Prolonged Release
2006-11-24
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1363/003/001 Case No: 2079004 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to SELANA HEALTHCARE LTD GARADICE HOUSE, 3-4 FAIRVIEW, DUBLIN 3 an authorisation, subject to the provisions of the said Regulations, in respect of the product FELODIPINE 5 MG, PROLONGED RELEASE 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 26/05/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 26/05/2010_ _CRN 2079004_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Felodipine 5 mg, prolonged release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged release tablet contains 5 mg of felodipine. Excipient: Each prolonged release tablet contains 22.75 mg lactose. For a full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Prolonged release tablet Light pink, round, biconvex, film-coated prolonged release tablet with imprint 5. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Essential hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Felodipine 5mg and Felodipine 10mg should usually be administered as follows: The recommended starting dose is 5 mg felodipine once dail Olvassa el a teljes dokumentumot