Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PACLITAXEL
Pliva Pharma Limited
6 Mg/Ml
Concentrate for Soln for Inf
2007-11-09
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0585/029/001 Case No: 2057324 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PLIVA PHARMA LIMITED VISION HOUSE, BEDFORD ROAD, PETERSFIELD, HAMPSHIRE GU32 3QB, 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 17/12/2008 until 08/11/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 17/12/2008_ _CRN 2057324_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paclitaxel 6mg/ml concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1ml of concentrate for solution for infusion contains 6mg paclitaxel. One vial of 5ml contains 30mg paclitaxel. One vial of 16.7ml contains 100mg paclitaxel. One vial of 50ml contains 300mg paclitaxel. Excipients: ethanol, anhydrous (395mg/ml) macrogolglycerol ricinoleate (527mg/ml) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion Paclitaxel is a clear yellow viscous solution 4 CLINICAL PARTICULARS 4.1 THERAPE Read the complete document