AREDIA Pdr/Conc/Soln for Infus 30 Anhyd Milligrams
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
PAMIDRONATE DISODIUM PENTAHYDRAT
Available from:
Novartis Pharmaceuticals UK Ltd
Dosage:
30 Anhyd Milligrams
Pharmaceutical form:
Pdr/Conc/Soln for Infus
Authorization date:
1993-11-11
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0013/090/002
Case No: 2081182
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
NOVARTIS PHARMACEUTICALS UK LTD
FRIMLEY BUSINESS PARK, FRIMLEY, CAMBERLEY, SURREY, GU16 7SR, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
AREDIA 30MG POWDER AND SOLVENT FOR CONCENTRATE FOR SOLUTION FOR INFUSION.
the particulars of which are set out in 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 13/08/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 13/08/2010_
_CRN 2081182_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aredia 30mg powder and solvent for concentrate for solution for infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 30 mg vial contains lyophilised pamidronate disodium pentahydrate equivalent to 30 mg pamidronate disodium
anhydrous.
A 10 ml ampoule of water for injections is supplied with each vial. When reconstituted, the concentration is 3mg/ml.
Further dilution is required.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for concentrate for solution for infusion (Powder and solvent for sterile concentrate)
White, lyophiliz
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