Imjudo

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tremelimumab

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

Overview

Imjudo is a cancer medicine for treating hepatocellular carcinoma (a type of liver cancer) in 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.

Hepatocellular carcinoma is rare, and Imjudo was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 9 December 2020. Further information on the orphan designation can be found here:EU/3/20/2370 .

Imjudo contains the active substance tremelimumab.

This EPAR was last updated on 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
L01FX
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
Date of issue of marketing authorisation valid throughout the European Union
20/02/2023
Contact address

151 85 Sodertalje
Sweden

Product information

20/02/2023 Imjudo - EMEA/H/C/006016 -

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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).

Assessment history

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