Alunbrig

RSS

brigatinib

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

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) who have been treated before with a cancer medicine called crizotinib.

Alunbrig is used on its own and only 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.

This EPAR was last updated on 18/02/2019

Authorisation details

Product details
Name
Alunbrig
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
Anatomical therapeutic chemical (ATC) code
L01XE43
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
Takeda Pharma A/S
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
22/11/2018
Contact address
Dybendal Alle 10
2630 Taastrup
Denmark

Product information

18/12/2018 Alunbrig - EMEA/H/C/004248 - IB/0001/G

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Treatment of adult patients with anaplastic lymphoma kinase positive advanced non-small cell lung cancer previously treated with crizotinib.

Assessment history

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