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ERLOTINIB APOTEX (Accelagen Pty Ltd)
Product name
ERLOTINIB APOTEX
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
145 working days (255)
Active ingredients
erlotinib hydrochloride
Registration type
New generic medicine
Indication
Non-Small Cell Lung Cancer
ERLOTINIB APOTEX (film coated tablet) is indicated for the first-line treatment of patients with advanced (Stage IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) with activating EGFR mutations.
ERLOTINIB APOTEX is indicated for maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutations who have not progressed on first-line chemotherapy.
ERLOTINIB APOTEX is also indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Pancreatic cancer
ERLOTINIB APOTEX in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine