GEMCITABINE Pdr for Soln for Infusion 1 Grams

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

GEMCITABINE HYDROCHLORIDE

Available from:

Rowex Ltd

Dosage:

1 Grams

Pharmaceutical form:

Pdr for Soln for Infusion

Authorization date:

2008-12-12

Summary of Product characteristics

                                
License
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. No.540 of 2007)
PA0711/178/002
Case No: 2062433
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
Gemcitabine 1 g 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 17/11/2009 until 21/08/2013.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
Irish Medicines Board
______________________________________________________________________________________________________________________
Date Printed 08/12/2009
CRN 2062433
page number: 1
Part II
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Gemcitabine 1 g powder for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One
                                
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