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EMA Product

Bavencio

Product approved by European Medicines Agency (EU)

Basic Information

Bavencio

Regulatory Information

EMEA/H/C/004338

Authorised

September 18, 2017

July 20, 2017

21

August 21, 2024

Company Information

the netherlands

Gustav Mahlerplein 102 1082 MA Amsterdam

Merck Europe BV

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC). Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). Bavencio is indicated as monotherapy for the first?line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum?based chemotherapy.

Overview Summary

Bavencio is a cancer medicine used to treat adults with: - Merkel cell carcinoma (MCC, a type of skin cancer), when the cancer has spread to other parts of the body; - Renal cell carcinoma (RCC, a cancer of the kidney), when the cancer is advanced; Bavencio is used in combination with another cancer medicine, axitinib; - Urothelial carcinoma (a type of bladder cancer), when the cancer is locally advanced or has spread to other parts of the body in patients whose cancer had not got worse after platinum-based chemotherapy. Bavencio contains the active substance avelumab.

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