Imfinzi

RSS

durvalumab

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

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.

This EPAR was last updated on 15/12/2022

Authorisation details

Product details
Name
Imfinzi
Agency product number
EMEA/H/C/004771
Active substance
durvalumab
International non-proprietary name (INN) or common name
durvalumab
Therapeutic area (MeSH)
Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code
L01XC28
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
AstraZeneca AB
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
21/09/2018
Contact address

151 85 Sodertalje
Sweden

Product information

13/12/2022 Imfinzi - EMEA/H/C/004771 - IAIN/0058

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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

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

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