F. Hoffmann-La Roche Ltd (batch release; storage; primary and secondary packaging, stability testing; stability testing (microbiological purity))

The drug is used for the adjuvant treatment of adult patients with ALK-positive non-small cell lung cancer at high risk of recurrence following tumor resection. It is also indicated for the treatment of advanced ALK-positive non-small cell lung cancer, particularly in patients who have previously received crizotinib.

Dosage form: capsules, hard

ATC: L01ED03