Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
OXALIPLATIN
Sanofi-Aventis Ireland Limited
5 Mg/Ml
Pdr for Soln for Infusion
2007-01-19
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0540/153/002 Case No: 2061120 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to SANOFI-AVENTIS IRELAND LIMITED CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product OXALIPLATIN WINTHROP 5MG/ML POWDER FOR SOLUTION FOR INFUSION the particulars of which are set out in 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 31/07/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 15/07/2010_ _CRN 2061120_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oxaliplatin Winthrop 5 mg/ml powder for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 50 mg vial: each vial contains 50 mg oxaliplatin for reconstitution in 10 ml of solvent. 100 mg vial: each vial contains 100 mg oxaliplatin for reconstitution in 20 ml of solvent. 1 ml of reconstituted solution for infusion contains 5 mg oxaliplatin Excipients - Contains Lactose Monohydrate 450mg/50mg vial and 900mg/100mg vial For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for infusion White to off-white cake or powder 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Olvassa el a teljes dokumentumot