Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
EPIRUBICIN HYDROCHLORIDE
Martindale Pharmaceuticals Ltd
EPIRUBICIN HYDROCHLORIDE
2 Mg/Ml
Solution for Inj/Inf
Product subject to prescription which may not be renewed (A)
Withdrawn
0000-00-00
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0361/023/001 Case No: 2045415 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to MARTINDALE PHARMACEUTICALS LTD BAMPTON ROAD, HAROLD HILL, ROMFORD, RM3 8UG, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product EPIRUBICIN MARTINDALE PHARMA 2 MG/ML SOLUTION FOR INJECTION/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 02/10/2009 until 01/10/2014. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 05/10/2009_ _CRN 2045415_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Epirubicin Martindale Pharma 2 mg/ml Solution for Injection/Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each millilitre of solution for injection/infusion contains 2 mg Epirubicin hydrochloride. Each 5 ml vial contains a total content of Epirubicin hydrochloride of 10 mg. Each 10 ml vial contains a total content of Epirubicin hydrochloride of 20 mg. Each 25 ml vial contains a total content of Epirubicin hydrochloride of 50 mg. Each 50 ml vial contains a total content of Epirubicin hydrochloride of 100 mg. Each 100 ml vial contains a tota Read the complete document