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.
Abraxane : EPAR - Summary for the public (PDF/93.17 KB)
First published: 10/08/2009
Last updated: 11/05/2015
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Celgene Europe B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
16/05/2019 Abraxane - EMEA/H/C/000778 - IA/0096
- 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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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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 January 201523/01/2015
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 November 201322/11/2013
European Medicines Agency recommends extending use of Abraxane to include treatment of pancreatic cancer22/11/2013