This medicine is authorised for use in the European Union.


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.


This EPAR was last updated on 30/08/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Neuroendocrine Tumors
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Merck Europe B.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Gustav Mahlerplein 102
1082 MA Amsterdam
The Netherlands

Product information

03/08/2023 Bavencio - EMEA/H/C/004338 - IB/0041

Other EU languages available icon This medicine’s product information is available in all official EU languages.
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Product information documents contain:

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

  • Other antineoplastic agents

  • Monoclonal antibodies

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.

Assessment history

Changes since initial authorisation of medicine

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