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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
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