GEMABIN Pdr for Soln for Infusion 1000 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
GEMCITABINE HYDROCHLORIDE
Available from:
Rowex Ltd
Dosage:
1000 Milligram
Pharmaceutical form:
Pdr for Soln for Infusion
Authorization date:
2007-10-26
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)
PA0711/112/002
Case No: 2059513
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ROWEX LTD
BANTRY, CO. CORK, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
GEMABIN 1000 MG POWDER 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 05/03/2009 until 25/10/2012.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 05/03/2009_
_CRN 2059513_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gemabin 1000 mg Powder for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1000 mg gemcitabine (as gemcitabine hydrochloride).
Each ml of Gemabin 1000 mg Powder for Solution for Infusion contains 40 mg gemcitabine when reconstituted in 25
ml.
Excipient:
Each 1000 mg vial contains 17.5 mg (< 1 mmol) sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for infusion.
White to slightly yellowish powder or cake.
After reconstitution of Gemabin 200 mg Powder for Solution for Infusion in 5 ml sterile 0.9% sodium chloride solution
or reconstituti
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