<p>This is a summary of the European public assessment report (EPAR) for Giotrif. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Giotrif.</p><p>For practical information about using Giotrif, patients should read the package leaflet or contact their doctor or pharmacist.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>Giotrif as monotherapy is indicated for the treatment of</p> <ul><li>Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s);</li> <li>locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.</li> </ul></div>
Therapeutic Area (MeSH)
ATC Code
L01XE13
ATC Item
N/A
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| afatinib | N/A | afatinib |
EMA Name
Giotrif
Medicine Name
Giotrif
Aliases
N/ANo risk management plan link.
