CALCORT 30 Milligram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
15-05-2024
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Active ingredient:
DEFLAZACORT
Available from:
Shire Pharmaceuticals Limited
INN (International Name):
DEFLAZACORT
Dosage:
30 Milligram
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Withdrawn
Authorization date:
2007-10-31
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0535/005/003
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 30MG 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 30 mg Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Deflazacort 30 mg.
Excipients: also includes lactose monohydrate 313 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 ‘30’ 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 diseases, pulmonary diseases,
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