Pazenir

RSS

paclitaxel

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

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;

  • 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.

This EPAR was last updated on 05/11/2019

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
GenericGeneric

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
Marketing-authorisation holder
ratiopharm GmbH
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
06/05/2019
Contact address

ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm
Germany
 

Product information

08/07/2019 Pazenir - EMEA/H/C/004441 - T/0001

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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.

Assessment history

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