Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
VINORELBINE TARTRATE
Cardinal Health UK 434 Limited
VINORELBINE TARTRATE
10 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Withdrawn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) PA1348/016/001 Case No: 2050861 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to CARDINAL HEALTH UK 434 LIMITED BAMPTON ROAD, HAROLD HILL, ROMFORD, ESSEX RM3 8UG, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product VINORELBINE MARTINDALE PHARMA 10 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 25/09/2009 until 24/09/2014. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/09/2009_ _CRN 2050861_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vinorelbine Martindale Pharma 10 mg/ml Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml concentrate for solution for infusion contains vinorelbine tartrate corresponding to 10 mg vinorelbine. Each 5 ml concentrate for solution for infusion contains vinorelbine tartrate corresponding to 50 mg vinorelbine. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for Solution for Infusion A clear colourless solution with a pH of 3.3 to 3.8 and an osmolarity of about 47 Pročitajte cijeli dokument