EPIRUBICIN Solution for Injection 2 Mg/Ml
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
23-04-2024
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Active ingredient:
EPIRUBICIN HYDROCHLORIDE
Available from:
Genepharm (Europe) Trading Ltd
Dosage:
2 Mg/Ml
Pharmaceutical form:
Solution for Injection
Authorization date:
2010-08-20
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA1658/002/001
Case No: 2085779
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
Transferred from PA0585/035/001.
GENEPHARM (EUROPE) TRADING LTD
EL GRECO HOUSE, 20 QUEEN FREDERICA ST., 1066 NICOSIA, CYPRUS
an authorisation, subject to the provisions of the said Regulations, in respect of the product
EPIRUBICIN 2MG/ML SOLUTION FOR INJECTION
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 20/08/2010 until 02/04/2014.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 20/08/2010_
_CRN 2085779_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Epirubicin 2 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre of solution for injection contains 2 mg epirubicin hydrochloride.
The content of sodium is 3.54mg per ml and per vial is as follows:
5ml vial 17.71mg, 10ml vial 35.42mg, 25ml vial 88.55mg, 50ml vial 177.1mg and 100ml vial 354.2mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for Injection.
A clear red solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Epirubicin is used in the treatment of a range of neoplastic conditions includi
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