← Drug database

Vizimpro (dacomitinib)

Region
🇪🇺 EU
Active substance
dacomitinib
Company
Pfizer Europe MA EEIG
Status
Authorised
Therapeutic area
Carcinoma, Non-Small-Cell Lung
CHMP opinion
Thu 31 Jan 2019
EU approval
Tue 02 Apr 2019
Application
EMEA/H/C/004779
ATC
L01EB07
Official record
www.ema.europa.eu

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.

Regulatory milestones

No milestones recorded in the last year.

Follow Vizimpro

Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.