Imjudo
tremelimumab
Table of contents
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.
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List item
Imjudo : EPAR - Medicine overview (PDF/138.67 KB)
First published: 02/03/2023
Last updated: 22/09/2023
EMA/301357/2023 -
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List item
Imjudo : EPAR - Risk management plan (PDF/552.39 KB)
First published: 02/03/2023
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 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 |
2
|
Date of issue of marketing authorisation valid throughout the European Union |
20/02/2023
|
Contact address |
151 85 Sodertalje |
Product information
04/08/2023 Imjudo - EMEA/H/C/006016 - II/0001
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
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.