Bavencio
avelumab
Table of contents
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.
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List item
Bavencio : EPAR - Medicine overview (PDF/120.99 KB)
First published: 13/10/2017
Last updated: 31/08/2020
EMA/423228/2020 -
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List item
Bavencio : EPAR - Risk-management-plan summary (PDF/329.25 KB) (updated)
First published: 04/11/2019
Last updated: 11/02/2021
Authorisation details
Product details | |
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Name |
Bavencio
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Agency product number |
EMEA/H/C/004338
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Active substance |
avelumab
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International non-proprietary name (INN) or common name |
avelumab
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Therapeutic area (MeSH) |
Neuroendocrine Tumors
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Anatomical therapeutic chemical (ATC) code |
L01XC31
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Additional 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 | |
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Marketing-authorisation holder |
Merck Europe B.V.
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Revision |
8
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Date of issue of marketing authorisation valid throughout the European Union |
18/09/2017
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Contact address |
Product information
21/01/2021 Bavencio - EMEA/H/C/004338 - II/0018; IB/0022
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
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Other antineoplastic agents
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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
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 December 202011/12/2020
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20/09/2019
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21/07/2017