Tagrisso
osimertinib
Table of contents
Overview
Tagrisso is a medicine for treating a lung cancer called non-small cell lung cancer (NSCLC).
It is used on its own in patients whose cancer cells have certain mutations (changes) in a gene for a
protein called EGFR.
• In patients whose cancer cells have genetic changes known as Ex19del or L858R and whose
cancer has not spread to other organs and has been completely removed by surgery, the
medicine is given to help prevent the cancer from coming back (adjuvant therapy).
• In patients whose cancer cells have mutations known as ‘activating mutations’ and whose
cancer is advanced or has spread, Tagrisso is given as the first treatment.
• In patients whose cancer cells have T790M mutations and whose cancer is advanced or has
spread, the medicine may be given after other treatments.
Tagrisso contains the active substance osimertinib.
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List item
Tagrisso : EPAR - Medicine overview (PDF/139.88 KB)
First published: 17/02/2016
Last updated: 09/07/2021 -
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List item
Tagrisso : EPAR - Risk-management-plan summary (PDF/230.05 KB)
First published: 30/11/2018
Last updated: 01/07/2021
Authorisation details
Product details | |
---|---|
Name |
Tagrisso
|
Agency product number |
EMEA/H/C/004124
|
Active substance |
osimertinib mesilate
|
International non-proprietary name (INN) or common name |
osimertinib
|
Therapeutic area (MeSH) |
Carcinoma, Non-Small-Cell Lung
|
Anatomical therapeutic chemical (ATC) code |
L01XE
|
Accelerated assessment |
This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment. |
Publication details | |
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Marketing-authorisation holder |
AstraZeneca AB
|
Revision |
19
|
Date of issue of marketing authorisation valid throughout the European Union |
01/02/2016
|
Contact address |
SE-151 85 Södertälje
Sweden |
Product information
28/09/2023 Tagrisso - EMEA/H/C/004124 - II/0052
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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Other antineoplastic agents
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Protein kinase inhibitors
Therapeutic indication
TAGRISSO as monotherapy is indicated for: - the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations - the first-line treatment of adult patients NSCLC with activating EGFR mutations. TAGRISSO as monotherapy is indicated for: |