Alunbrig
brigatinib
Table of contents
Overview
Alunbrig is a cancer medicine that is used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). It is used in patients who have not been treated before with a medicine of the ALK inhibitor class or who have been treated before with the ALK-inhibitor crizotinib.
Alunbrig is only used if the NSCLC is ‘ALK-positive’, which means that the cancer cells have certain changes affecting the gene that makes a protein called ALK (anaplastic lymphoma kinase).
Alunbrig contains the active substance brigatinib.
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Alunbrig : EPAR - Medicine overview (PDF/124.09 KB)
First published: 26/11/2018
Last updated: 11/06/2020
EMA/124022/2020 -
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Alunbrig : EPAR - Risk-management-plan summary (PDF/72.64 KB)
First published: 26/11/2018
Last updated: 11/06/2020
Authorisation details
Product details | |
---|---|
Name |
Alunbrig
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Agency product number |
EMEA/H/C/004248
|
Active substance |
brigatinib
|
International non-proprietary name (INN) or common name |
brigatinib
|
Therapeutic area (MeSH) |
Carcinoma, Non-Small-Cell Lung
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Anatomical therapeutic chemical (ATC) code |
L01XE43
|
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 |
Takeda Pharma A/S
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Revision |
5
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Date of issue of marketing authorisation valid throughout the European Union |
22/11/2018
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Contact address |
Product information
11/12/2020 Alunbrig - EMEA/H/C/004248 - IAIN/0026/G
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
Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.
Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase ALKpositive advanced NSCLC previously treated with crizotinib.