Vizimpro
dacomitinib
Table of contents
Overview
Vizimpro is a cancer medicine used to treat adults with non small cell lung cancer (NSCLC) when the disease is advanced or has spread.
Vizimpro is used on its own and only in patients with certain mutations (changes) in the gene for a protein called epidermal growth factor receptor (EGFR).
Vizimpro contains the active substance dacomitinib.
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Vizimpro : EPAR - Medicine overview (PDF/107.59 KB)
First published: 05/06/2019
EMA/89209/2019 -
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Vizimpro : EPAR - Risk-management-plan summary (PDF/89.74 KB)
First published: 05/06/2019
Last updated: 22/02/2021
Authorisation details
Product details | |
---|---|
Name |
Vizimpro
|
Agency product number |
EMEA/H/C/004779
|
Active substance |
dacomitinib monohydrate
|
International non-proprietary name (INN) or common name |
dacomitinib
|
Therapeutic area (MeSH) |
Carcinoma, Non-Small-Cell Lung
|
Anatomical therapeutic chemical (ATC) code |
L01EB07
|
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 |
Pfizer Europe MA EEIG
|
Revision |
2
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Date of issue of marketing authorisation valid throughout the European Union |
02/04/2019
|
Contact address |
Boulevard de la Plaine 17 |
Product information
02/07/2021 Vizimpro - EMEA/H/C/004779 - IA/0007
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
Antineoplastic agents
Therapeutic indication
Vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations.