Tremelimumab AstraZeneca



This medicine is authorised for use in the European Union.


Tremelimumab AstraZeneca is a cancer medicine for treating non-small cell lung cancer (NSCLC) that has metastasised (spread to other parts of the body) in adults who have not been treated before. It is given together with durvalumab (another cancer medicine) and platinum-based chemotherapy, and is used when the cancer has shown no mutations (changes) in the so-called EGFR and ALK genes.

Tremelimumab AstraZeneca contains the active substance tremelimumab.

This EPAR was last updated on 11/09/2023

Authorisation details

Product details
Tremelimumab AstraZeneca
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code
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
Contact address

151 85 Sodertalje

Product information

04/09/2023 Tremelimumab AstraZeneca - EMEA/H/C/004650 - IG1659

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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

Tremelimumab AstraZeneca 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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