Abraxane
paclitaxel
Table of contents
Overview
This is a summary of the European Public Assessment Report (EPAR) for Abraxane. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Abraxane.
Authorisation details
Product details | |
---|---|
Name |
Abraxane
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Agency product number |
EMEA/H/C/000778
|
Active substance |
paclitaxel
|
International non-proprietary name (INN) or common name |
paclitaxel
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L01CD01
|
Publication details | |
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Marketing-authorisation holder |
Celgene Europe B.V.
|
Revision |
27
|
Date of issue of marketing authorisation valid throughout the European Union |
11/01/2008
|
Contact address |
Product information
02/10/2020 Abraxane - EMEA/H/C/000778 - IB/0104
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated.
Abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.
Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
Assessment history
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 January 201523/01/2015
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22/11/2013
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22/11/2013