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EMA Product

Pazenir

Product approved by European Medicines Agency (EU)

Basic Information

Pazenir

Regulatory Information

EMEA/H/C/004441

Authorised

May 6, 2019

February 28, 2019

9

August 30, 2024

Company Information

Germany

ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm

ratiopharm GmbH

Drug Classification

Generic Medicine

Active Substances Detail

Detailed Information

Therapeutic Indication

### 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.

Overview Summary

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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