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EMA Product

Eribulin Baxter

Product approved by European Medicines Agency (EU)

Basic Information

Eribulin Baxter

Regulatory Information

EMEA/H/C/006191

Authorised

June 27, 2024

April 25, 2024

1

December 2, 2024

Company Information

Netherlands

Kobaltweg 49 3542 CE Utrecht

Baxter Holding BV

Drug Classification

Generic Medicine

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Eribulin Baxter is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments. Eribulin Baxter is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease

Overview Summary

Eribulin Baxter is a cancer medicine used to treat locally advanced or metastatic breast cancer which has continued to spread after at least one previous treatment for advanced cancer. Previous treatment should have included cancer medicines of the types known as anthracyclines and taxanes, unless these treatments were not suitable. ‘Metastatic’ means that the cancer has spread to other parts of the body. Eribulin Baxter is also used to treat adults with advanced or metastatic liposarcoma (a type of cancer of the soft tissues that develops from fat cells) that cannot be surgically removed. It is used in patients who have already been treated with anthracyclines (unless this treatment was not suitable). Eribulin Baxter contains the active substance eribulin and is a ‘generic medicine’. This means that Eribulin Baxter contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Eribulin Baxter is Halaven. For more information on generic medicines, see the question-and-answer document [here](https://www.ema.europa.eu/en/documents/other/questions-and-answers-generic-medicines_en.pdf).

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