Bavencio

RSS

avelumab

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

Overview

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 19/10/2022

Authorisation details

Product details
Name
Bavencio
Agency product number
EMEA/H/C/004338
Active substance
avelumab
International non-proprietary name (INN) or common name
avelumab
Therapeutic area (MeSH)
Neuroendocrine Tumors
Anatomical therapeutic chemical (ATC) code
L01FF04
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.
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
18/09/2017
Contact address

Gustav Mahlerplein 102
1082 MA Amsterdam
The Netherlands

Product information

15/09/2022 Bavencio - EMEA/H/C/004338 - II/0035

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

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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