DOXORUBICIN MARTINDALE PHARMA
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-04-2024
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Active ingredient:
DOXORUBICIN HYDROCHLORIDE
Available from:
Martindale Pharmaceuticals Ltd
Dosage:
2 Mg/Ml
Pharmaceutical form:
Concentrate for Soln for Inf
Authorization date:
2009-09-04
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)
PA0361/024/001
Case No: 2045379
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
MARTINDALE PHARMACEUTICALS LTD
BAMPTON ROAD, HAROLD HILL, ROMFORD, RM3 8UG, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
DOXORUBICIN MARTINDALE PHARMA 2 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 04/09/2009 until 03/09/2014.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 05/09/2009_
_CRN 2045379_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Doxorubicin Martindale Pharma 2 mg/ml Concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre of concentrate for solution for infusion contains 2 mg Doxorubicin hydrochloride.
Each 5ml vial contains a total content of Doxorubicin hydrochloride of 10 mg.
Each 10ml vial contains a total content of Doxorubicin hydrochloride of 20 mg.
Each 25ml vial contains a total content of Doxorubicin hydrochloride of 50 mg.
Each 75ml vial contains a total content of Doxorubicin hydrochloride of 150 mg.
Each 100ml vi
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