Imfinzi

RSS

durvalumab

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

Overview

Imfinzi is a medicine used to treat a type of lung cancer called non-small cell lung cancer (NSCLC).

Imfinzi is used in adult patients with advanced cancer that cannot be removed by surgery but is not getting worse after treatment with radiation and platinum-based chemotherapy (medicines to treat cancer). Imfinzi is used specifically when the tumour produces a protein known as PD-L1.

Imfinzi contains the active substance durvalumab.

This EPAR was last updated on 30/10/2018

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 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
0
Date of issue of marketing authorisation valid throughout the European Union
20/09/2018
Contact address
SE-151-85 Sodertalje
Sweden

Product information

20/09/2018 Imfinzi - EMEA/H/C/004771 - -

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

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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