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.

Bavencio is also used in combination with another cancer medicine, axitinib, for the initial treatment of patients with advanced renal cell carcinoma (RCC, a cancer of the kidney).

Bavencio contains the active substance avelumab.

This EPAR was last updated on 04/11/2019

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
L01XC31
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.

Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Publication details
Marketing-authorisation holder
Merck Europe B.V.
Revision
5
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

24/10/2019 Bavencio - EMEA/H/C/004338 - II/0009/G

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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).

Assessment history

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