Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
COLECALCIFEROL CALCIUM CARBONATE
Procter & Gamble Pharmaceuticals UK Limited
COLECALCIFEROL CALCIUM CARBONATE
1000 Milligram
Granules Effervescent
Product not subject to medical prescription
Withdrawn
2010-03-11
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0170/018/002 Case No: 2046809 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PROCTER & GAMBLE PHARMACEUTICALS RUSHAM PARK, WHITEHALL LANE, EGHAM, SURREY TW20 9NW, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product CACIT D3 1000 MG / 880 IU, EFFERVESCENT GRANULES FOR ORAL SOLUTION. 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 04/07/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 05/07/2008_ _CRN 2046809_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cacit D3 1000 mg / 880 IU, Effervescent Granules for Oral Solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One sachet of 8 g contains : For excipients, see 6.1. 3 PHARMACEUTICAL FORM Effervescent white granules for oral solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Correction of vitamin D and calcium combined deficiency in elderly people. Vitamin D and calcium supplementation as an adjunct to specific therapy for osteoporosis treatment in patients with established, or at high risk of vitamin D and calcium combined deficiencies. 4.2 POSO Baca dokumen lengkap