Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
ALENDRONATE SODIUM
Pliva Pharma Limited
70 Milligram
Tablets
2006-12-08
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0585/025/002 Case No: 2071003 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PLIVA PHARMA LIMITED VISION HOUSE, BEDFORD ROAD, PETERSFIELD, HAMPSHIRE GU32 3QB, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product FOSALEN ONCE WEEKLY 70 MG 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 11/02/2010 until 07/12/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 13/02/2010_ _CRN 2071003_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fosalen Once Weekly 70mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 70mg alendronic acid (as sodium alendronate trihydrate) Excipients: Each tablet contains 142.64 mg of lactose monohydrate. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off-white, oval tablet, embossed "AN 70" on one side and the Arrow logo on the other. 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 Lue koko asiakirja