APO-GEFITINIB, GEFITINIB APOTEX (Apotex Pty Ltd)
Product name
APO-GEFITINIB, GEFITINIB APOTEX
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
176 working days (255)
Active ingredients
gefitinib
Registration type
New generic medicine
Indication
APO-GEFITINIB, GEFITINIB APOTEX (film coated tablets) is indicated for the treatment of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) whose tumours express activating mutations of the epidermal growth factor receptor (EGFR) tyrosine kinase.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine