Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
GEMCITABINE HYDROCHLORIDE
Rowex Ltd
GEMCITABINE HYDROCHLORIDE
1000 Milligram
Pdr for Soln for Infusion
Product subject to prescription which may not be renewed (A)
Withdrawn
2010-09-07
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 Lugege kogu dokumenti