Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
EPIRUBICIN
Techno-Pharm Limited
2 Mg/Ml
Solution for Inj/Inf
2006-02-17
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0754/008/001 Case No: 2044953 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to TECHNO-PHARM LIMITED PHARMAPARK, CHAPELIZOD, DUBLIN 20, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product EPIRUBICIN "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 24/01/2008 until 16/02/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 25/01/2008_ _CRN 2044953_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Epirubicin "EBEWE" 2mg/ml concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml concentrate for solution for infusion and injection contains 2mg Epirubicin hydrochloride Each 5ml concentrate for solution for infusion and injection contains 10mg Epirubicin hydrochloride Each 25ml concentrate for solution for infusion and injection contains 50mg Epirubicin hydrochloride Each 50ml concentrate for solution for infusion and injection contains 100mg Epirubicin hydrochloride Each 100ml concentrate for solution for infusion and injection contains 200mg Epirubicin Lugege kogu dokumenti