देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
PACLITAXEL
Stragen UK Limited
PACLITAXEL
6 Mg/Ml
Concentrate for Soln for Inf
Product subject to prescription which may not be renewed (A)
Withdrawn
2009-12-07
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1294/003/001 Case No: 2029946 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to STRAGEN UK LIMITED CASTLE COURT, 41 LONDON ROAD, REIGATE, SURREY RH2 9RJ, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product PACLITAXEL 6 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 11/04/2008 until 10/04/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 15/04/2008_ _CRN 2029946_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paclitaxel 6 mg/ml Concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of concentrate for solution for infusion contains 6 mg paclitaxel. A vial of 5 ml contains 30 mg of paclitaxel. A vial of 16.7 ml contains 100 mg of paclitaxel. A vial of 25 ml contains 150 mg of paclitaxel. A vial of 50 ml contains 300 mg of paclitaxel Excipients: Ethanol anhydrous: 396 mg/ml Macrogolglycerol ricinoleate: 527 mg/ml For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, colourl पूरा दस्तावेज़ पढ़ें