CACIT D3 1000 Milligram Granules Effervescent
Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Tabia za bidhaa
(SPC)
19-04-2024
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Viambatanisho vya kazi:
COLECALCIFEROL CALCIUM CARBONATE
Inapatikana kutoka:
Procter & Gamble Pharmaceuticals UK Limited
INN (Jina la Kimataifa):
COLECALCIFEROL CALCIUM CARBONATE
Kipimo:
1000 Milligram
Dawa fomu:
Granules Effervescent
Dawa ya aina:
Product not subject to medical prescription
Idhini hali ya:
Withdrawn
Idhini ya tarehe:
2010-03-11
Tabia za bidhaa
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
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