Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
IRINOTECAN HYDROCHLORIDE TRIHYDRATE
Martindale Pharmaceuticals Ltd
IRINOTECAN HYDROCHLORIDE TRIHYDRATE
20 Mg/Ml
Concentrate for Soln for 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Withdrawn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) PA0361/028/001 Case No: 2051061 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 IRINOTECAN MARTINDALE PHARMA 20 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 23/04/2010 until 22/04/2015. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 27/04/2010_ _CRN 2051061_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Irinotecan Martindale Pharma 20 mg/ml Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of concentrate contains 20 mg irinotecan hydrochloride trihydrate equivalent to 17.33 mg/ml irinotecan. Each 2 ml or 5ml vial of Irinotecan contains 40 mg or 100 mg of irinotecan hydrochloride trihydrate respectively. Excipients: Sorbitol (E240) Sodium hydroxide For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for Solution for Infusion Clear, colourless to slightly yellow solution. 4 CLINICAL Aqra d-dokument sħiħ