Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
CALCITRIOL
Roche Products Ltd
0.5 Microgram
Capsule
1980-02-18
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0050/047/002 Case No: 2033493 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ROCHE PRODUCTS LTD 6 FALCON WAY, SHIRE PARK, WELWYN GARDEN CITY, AL7 1TW, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product ROCALTROL 0.5 MICROGRAM CAPSULES 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 16/02/2007 until 17/02/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/04/2007_ _CRN 2033493_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rocaltrol 0.5 microgram capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 0.5 micrograms of calcitriol. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Capsule, soft Both lengths brown-red to orange-grey opaque. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rocaltrol is indicated for the correction of the abnormalities of calcium and phosphate metabolism in patients with renal osteodystrophy. Rocaltrol is also indicated for the treatment of established post-menopausal osteoporosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dose of Rocaltrol should be carefully adjusted for each patient a Lestu allt skjalið