Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
GEMCITABINE HYDROCHLORIDE
Rowex Ltd
1 Grams
Pdr for Soln for Infusion
2008-12-12
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 vial contains gemcitabine hydrochloride equivalent to 1000 mg gemcitabine. After reconstitution, the solution contains 38 mg/ml of gemcitabine. Excipients 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 off-white lyophilized cake. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gemcitabine is indicated for the treatment of locally advanced or metastatic bladder cancer in combination with cisplatin. Gemcitabine is in Baca dokumen lengkap