Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
CISPLATIN
Ebewe Pharma Ges.m.b.H Nfg. KG
1
Concentrate for Soln for Inf
2001-11-02
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0789/002/005 Case No: 2060821 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to EBEWE PHARMA GES.M.B.H NFG. KG MONDSEESTRASSE 11, A-4866 UNTERACH, AUSTRIA an authorisation, subject to the provisions of the said Regulations, in respect of the product CISPLATIN 'EBEWE' 1 MG/ML - CONCENTRATE 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 15/09/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/09/2009_ _CRN 2060821_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cisplatin ‘Ebewe’ 1 mg/ml – Concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 1 mg cisplatin. 1 vial of 10 ml concentrate for solution for infusion contains 10 mg cisplatin. 1 vial of 20 ml concentrate for solution for infusion contains 20 mg cisplatin. 1 vial of 50 ml concentrate for solution for infusion contains 50 mg cisplatin. 1 vial of 100 ml concentrate for solution for infusion contains 100 mg cisplatin. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion The conc Olvassa el a teljes dokumentumot