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IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0754/008/001
Case No: 2044953
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
TECHNO-PHARM LIMITED
PHARMAPARK, CHAPELIZOD, DUBLIN 20, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
EPIRUBICIN "EBEWE" 2MG/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 24/01/2008 until 16/02/2011.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 25/01/2008_
_CRN 2044953_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Epirubicin "EBEWE" 2mg/ml concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml concentrate for solution for infusion and injection contains 2mg Epirubicin hydrochloride
Each 5ml concentrate for solution for infusion and injection contains 10mg Epirubicin hydrochloride
Each 25ml concentrate for solution for infusion and injection contains 50mg Epirubicin hydrochloride
Each 50ml concentrate for solution for infusion and injection contains 100mg Epirubicin hydrochloride
Each 100ml concentrate for solution for infusion and injection contains 200mg Epirubicin
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