Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DOXORUBICIN HYDROCHLORIDE
Ebewe Pharma Ges.m.b.H Nfg. KG
2 Mg/Ml
Concentrate for Soln for Inf
1999-01-22
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0789/001/001 Case No: 2068686 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 DOXORUBICIN "EBEWE" 2MG/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 14/07/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 15/07/2009_ _CRN 2068686_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Doxorubicin "Ebewe" 2 mg/ml, Concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 2 mg doxorubicin hydrochloride. Each 5 ml vial contains 10 mg of doxorubicin hydrochloride. Each 25 ml vial contains 50 mg of doxorubicin hydrochloride Each 50 ml vial contains 100 mg of doxorubicin hydrochloride Each 100 ml vial contains 200 mg of doxorubicin hydrochloride For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, red coloured solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Doxor Read the complete document