ELOXATIN Pdr for Soln for Infusion 5 Mg/Ml
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
OXALIPLATIN
Available from:
Sanofi-Aventis Ireland Limited
Dosage:
5 Mg/Ml
Pharmaceutical form:
Pdr for Soln for Infusion
Authorization date:
2007-01-19
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0540/148/002
Case No: 2061120
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
SANOFI-AVENTIS IRELAND LIMITED
CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ELOXATIN 5MG/ML, POWDER 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 31/07/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 15/07/2010_
_CRN 2061120_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eloxatin 5 mg/ml, powder for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
50 mg vial: each vial contains 50 mg oxaliplatin for reconstitution in 10 ml of solvent.
100 mg vial: each vial contains 100 mg oxaliplatin for reconstitution in 20 ml of solvent.
1 ml of reconstituted solution for infusion contains 5 mg oxaliplatin
Excipients - Contains Lactose Monohydrate 450mg/50mg vial and 900mg/100mg vial
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for infusion
White to off-white cake or powder
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oxaliplatin in combina
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