OXALIPLATIN WINTHROP
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
OXALIPLATIN
Available from:
Sanofi-Aventis Ireland Limited
Dosage:
5 Mg/Ml
Pharmaceutical form:
Concentrate for Soln for Inf
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
PA0540/153/001
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
OXALIPLATIN WINTHROP 5 MG/ML 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 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
Oxaliplatin Winthrop 5 mg/ml Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of concentrate for solution for infusion contains 5 mg oxaliplatin
10 ml of concentrate for solution for infusion contains 50 mg of oxaliplatin
20 ml of concentrate for solution for infusion contains 100 mg of oxaliplatin
40 ml of concentrate for solution for infusion contains 200 mg of oxaliplatin
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless liquid
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oxaliplatin in comb
Read the complete document
