Abraxane

RSS

paclitaxel

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 31/08/2018

Authorisation details

Product details
Name
Abraxane
Agency product number
EMEA/H/C/000778
Active substance
paclitaxel
International non-proprietary name (INN) or common name
paclitaxel
Therapeutic area (MeSH)
  • Breast Neoplasms
  • Pancreatic Neoplasms
  • Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code
L01CD01
Publication details
Marketing-authorisation holder
Celgene Europe B.V. 
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
11/01/2008
Contact address
Celgene Europe B.V.
Winthontlaan 6 N
3526KV Utrecht
The Netherlands

Product information

30/07/2018 Abraxane - EMEA/H/C/000778 - T/0091

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

Please note that the size of the above document can exceed 50 pages.

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

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