Imjudo

RSS

tremelimumab

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

Overview

Imjudo is a cancer medicine. It is used to treat:

  • hepatocellular carcinoma (a type of liver cancer) in adult patients who have not been treated before and whose disease is advanced or unresectable (cannot be removed by surgery). It is used in combination with durvalumab, another cancer medicine;
  • non-small cell lung cancer (NSCLC) that has metastasised (spread to other parts of the body) in adult patients who have not been treated before. It is given together with durvalumab and platinum-based chemotherapy and is used when the cancer has shown no mutations (changes) in the so-called EGFR and ALK

 Imjudo contains the active substance tremelimumab.

This EPAR was last updated on 22/09/2023

Authorisation details

Product details
Name
Imjudo
Agency product number
EMEA/H/C/006016
Active substance
Tremelimumab
International non-proprietary name (INN) or common name
tremelimumab
Therapeutic area (MeSH)
Carcinoma, Hepatocellular
Anatomical therapeutic chemical (ATC) code
L01FX20
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
2
Date of issue of marketing authorisation valid throughout the European Union
20/02/2023
Contact address

151 85 Sodertalje
Sweden

Product information

04/08/2023 Imjudo - EMEA/H/C/006016 - II/0001

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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

Imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).

Imjudo in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.

Assessment history

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