CISPLATIN "EBEWE"
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
16-04-2024
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Active ingredient:
CISPLATIN
Available from:
Ebewe Pharma Ges.m.b.H Nfg. KG
Dosage:
1
Pharmaceutical form:
Concentrate for Soln for Inf
Authorization date:
2001-11-02
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)
PA0789/002/005
Case No: 2060821
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
EBEWE PHARMA GES.M.B.H NFG. KG
MONDSEESTRASSE 11, A-4866 UNTERACH, AUSTRIA
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CISPLATIN 'EBEWE' 1 MG/ML - CONCENTRATE FOR SOLUTION FOR INFUSION
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 15/09/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 16/09/2009_
_CRN 2060821_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cisplatin ‘Ebewe’ 1 mg/ml – Concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 1 mg cisplatin.
1 vial of 10 ml concentrate for solution for infusion contains 10 mg cisplatin.
1 vial of 20 ml concentrate for solution for infusion contains 20 mg cisplatin.
1 vial of 50 ml concentrate for solution for infusion contains 50 mg cisplatin.
1 vial of 100 ml concentrate for solution for infusion contains 100 mg cisplatin.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
The conc
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