CYTARABINE EBEWE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
11-05-2024
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Active ingredient:
CYTARABINE
Available from:
Techno-Pharm Limited
Dosage:
50 Mg/Ml
Pharmaceutical form:
Solution for Inj/Inf
Authorization date:
2006-11-10
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)
PA0754/009/002
Case No: 2082584
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
CYTARABINE EBEWE 50MG/ML SOLUTION FOR INJECTION OR 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 08/06/2010 until 09/11/2011.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 08/06/2010_
_CRN 2082584_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cytarabine Ebewe 50mg/ml solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml solution for injection or infusion contains 50 mg Cytarabine
Each 10ml solution for injection or infusion contains 500 mg Cytarabine
Each 20ml solution for injection or infusion contains 1000 mg Cytarabine
Each 40ml solution for injection or infusion contains 2000 mg Cytarabine
For Excipients see 6.1
3 PHARMACEUTICAL FORM
Solution for injection or infusion
Clear, colourless sterile solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cytarabine can be used alone or in combi
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