Vizimpro

RSS

dacomitinib

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

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.

This EPAR was last updated on 05/06/2019

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
L01XE47
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
Pfizer Europe MA EEIG
Date of issue of marketing authorisation valid throughout the European Union
02/04/2019
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

02/04/2019 Vizimpro - EMEA/H/C/004779 -

Contents

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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.

Assessment history

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