البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
GEMCITABINE HYDROCHLORIDE
Martindale Pharmaceuticals Ltd
1000 Milligram
Pdr for Soln for Infusion
2009-10-09
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0361/022/002 Case No: 2050873 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to MARTINDALE PHARMACEUTICALS LTD BAMPTON ROAD, HAROLD HILL, ROMFORD, RM3 8UG, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product GEMCITABINE MARTINDALE PHARMA 1000MG 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 09/10/2009 until 08/10/2014. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 09/10/2009_ _CRN 2050873_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gemcitabine Martindale Pharma 1000mg Powder for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains gemcitabine hydrochloride equivalent to 1000 mg gemcitabine. One ml of the solution for injection contains 38mg gemcitabine (as gemcitabine hydrochloride) after reconstitution with 25ml of sterile sodium chloride 9 mg/ml (0.9 %) solution. Excipients One 1000mg vial contains approximately 0.75mmol (17.5 mg) of sodium. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for infusion. White اقرأ الوثيقة كاملة