Pazenir
paclitaxel
Table of contents
Overview
Pazenir is used to treat the following cancers in adults:
- metastatic breast cancer, when the first treatment has stopped working and standard treatment including an anthracycline (another type of cancer medicine) is not suitable. ‘Metastatic’ means that the cancer has spread to other parts of the body;
- metastatic adenocarcinoma of the pancreas, as a first treatment in combination with another cancer medicine, gemcitabine;
- non-small cell lung cancer, as a first treatment in combination with the cancer medicine carboplatin when the patient cannot have surgery or radiotherapy.
Pazenir contains the active substance paclitaxel attached to a human protein called albumin and is a ‘generic medicine’. This means that Pazenir contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Abraxane.
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List item
Pazenir : EPAR - Medicine overview (PDF/169.53 KB)
Adopted
First published: 23/05/2019
Last updated: 04/02/2020
EMA/159292/2019 -
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List item
Pazenir : EPAR - Risk-management-plan summary (PDF/238.49 KB)
First published: 23/05/2019
Authorisation details
Product details | |
---|---|
Name |
Pazenir
|
Agency product number |
EMEA/H/C/004441
|
Active substance |
paclitaxel
|
International non-proprietary name (INN) or common name |
paclitaxel
|
Therapeutic area (MeSH) |
Breast Neoplasms
|
Anatomical therapeutic chemical (ATC) code |
L01CD01
|
Generic |
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines. |
Publication details | |
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Marketing-authorisation holder |
ratiopharm GmbH
|
Revision |
7
|
Date of issue of marketing authorisation valid throughout the European Union |
06/05/2019
|
Contact address |
ratiopharm GmbH |
Product information
09/03/2022 Pazenir - EMEA/H/C/004441 - IB/0010/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Pazenir 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.
Pazenir 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.