CALCIUM-D-SANDOZ Tablets Effervescent 600mg+400I Base Milligrams
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
CALCIUM CARBONATE COLECALCIFEROL
Available from:
Novartis Consumer Health UK Limited
Dosage:
600mg+400I Base Milligrams
Pharmaceutical form:
Tablets Effervescent
Authorization date:
2000-04-28
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)
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
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