Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
CALCIUM CARBONATE COLECALCIFEROL
Novartis Consumer Health UK Limited
CALCIUM CARBONATE COLECALCIFEROL
600mg+400I Base Milligrams
Tablets Effervescent
Product not subject to medical prescription
Authorised
0000-00-00
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0030/038/001 Case No: 2075491 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to NOVARTIS CONSUMER HEALTH UK LIMITED WIMBLEHURST ROAD, HORSHAM, WEST SUSSEX RH12 5AB, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product CALCIUM-D-SANDOZ 600 MG + 400 IU, EFFERVESCENT 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 30/03/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 31/03/2010_ _CRN 2075491_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calcium-D-Sandoz 600 mg + 400 IU, effervescent tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 effervescent tablet contains 1500 mg of calcium carbonate (equivalent to 600 mg or 15 mmol of calcium) 400 I.U. or 10 µg cholecalciferol (vitamin D 3 ) as cholecalciferol concentrate ‘powder form’. Excipient(s): 52 mg of sodium, 1.52 mg of sucrose, 50 mg of lemon flavouring (contains: sorbitol (E 420)), 0.30 mg of partially hydrogenated soybean oil For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Effervescent tablet White-round tablet, smooth Lestu allt skjalið