Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ALENDRONATE SODIUM
Gedeon Richter Plc
70 Milligram
Film Coated Tablet
2007-12-19
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1330/002/001 Case No: 2040878 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to GEDEON RICHTER LTD H-1103 BUDAPEST, GYOMROI UT 19-21, HUNGARY an authorisation, subject to the provisions of the said Regulations, in respect of the product ALENDRONIC ACID 70MG "ONCE WEEKLY" 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 22/01/2008 until 18/12/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 23/01/2008_ _CRN 2040878_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alendronic Acid 70mg "once weekly" film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 70mg alendronic acid (equivalent to 91.35 mg sodium alendronate trihydrate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet. White, round, biconvex film-coated tablet with engraving “M14”. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of post menopausal osteoporosis. Alendronate reduces the risk of vertebral and hip fractures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dosage is one70mg film-coat Read the complete document