PACLITAXEL Concentrate for Soln for Inf 6 Mg/Ml
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
PACLITAXEL
Available from:
Stragen UK Limited
Dosage:
6 Mg/Ml
Pharmaceutical form:
Concentrate for Soln for Inf
Authorization date:
2008-04-11
Summary of Product characteristics
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
Read the complete document
