Tagrisso

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osimertinib

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

Overview

 

Tagrisso is medicine for treating a lung cancer called non-small cell lung cancer (NSCLC) when the cancer is advanced or has spread.

It is used in patients who have mutations (changes) in a gene for a protein called EGFR. If a patient has mutations known as an ‘activating mutations’, Tagrisso is given as the first treatment. In patients with T790 mutation, the medicine may be given after other treatments.

It contains the active substance osimertinib.

This EPAR was last updated on 30/11/2018

Authorisation details

Product details
Name
Tagrisso
Agency product number
EMEA/H/C/004124
Active substance
osimertinib mesylate
International non-proprietary name (INN) or common name
osimertinib
Therapeutic area (MeSH)
Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code
L01XE
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
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
01/02/2016
Contact address
SE-151 85 Södertälje
Sweden

Product information

31/08/2018 Tagrisso - EMEA/H/C/004124 - II/0024

Contents

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Pharmacotherapeutic group

  • OTHER ANTINEOPLASTIC AGENTS
  • Protein kinase inhibitors

Therapeutic indication

Tagrisso is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small-cell lung cancer (NSCLC).

Assessment history

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