Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
DEFLAZACORT
Shire Pharmaceuticals Limited
DEFLAZACORT
6 Milligram
Tablets
Product subject to prescription which may not be renewed (A)
Withdrawn
2007-12-31
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0535/005/002 Case No: 2026443 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to SHIRE PHARMACEUTICALS LIMITED HAMPSHIRE INTERNATIONAL BUSINESS PARK, CHINEHAM, BASINGSTOKE, HAMPSHIRE RG24 8EP, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product CALCORT 6MG 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 14/08/2007. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 03/11/2007_ _CRN 2026443_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calcort 6mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Deflazacort 6 mg. Excipients: Also includes lactose monohydrate 142 mg per tablet, and sucrose 7 mg per tablet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Round white tablet, marked with a cross on one face and ‘6’ on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A wide range of conditions may sometimes need treatment with glucocorticoids. The indications include: Primary and secondary adrenocortical insufficiency, rheumatic disorders, collagen dise Læs hele dokumentet