Imfinzi
durvalumab
Table of contents
Overview
Imfinzi is a medicine used to treat lung cancer. It for use in adults with:
- non-small cell lung cancer (NSCLC) that cannot be removed by surgery but is not getting worse after radiation treatment and platinum-based chemotherapy (medicines to treat cancer). Imfinzi is used specifically when the cancer produces a protein known as PD-L1;
- small cell lung cancer (SCLC) that has spread within the lungs or to other parts of the body (extensive-stage SCLC) and has not been treated previously. Imfinzi is given together with etoposide and either carboplatin or cisplatin (chemotherapy medicines).
Imfinzi contains the active substance durvalumab.
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List item
Imfinzi : EPAR - Medicine overview (PDF/142.55 KB)
First published: 30/10/2018
Last updated: 15/12/2022
EMA/419133/2020 -
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List item
Imfinzi : EPAR - Risk-management-plan summary (PDF/93.52 KB)
First published: 30/10/2018
Last updated: 20/10/2020
Authorisation details
Product details | |
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Name |
Imfinzi
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Agency product number |
EMEA/H/C/004771
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Active substance |
durvalumab
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International non-proprietary name (INN) or common name |
durvalumab
|
Therapeutic area (MeSH) |
Carcinoma, Non-Small-Cell Lung
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Anatomical therapeutic chemical (ATC) code |
L01XC28
|
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 |
AstraZeneca AB
|
Revision |
14
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Date of issue of marketing authorisation valid throughout the European Union |
21/09/2018
|
Contact address |
151 85 Sodertalje |
Product information
13/12/2022 Imfinzi - EMEA/H/C/004771 - IAIN/0058
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
Antineoplastic agents
Therapeutic indication
Imfinzi as monotherapy is indicated for the treatment of locally advanced, unresectable non‑small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum‑based chemoradiation therapy.
Assessment history
News
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16/12/2022
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 202211/11/2022
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24/07/2020
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27/07/2018