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NERLYNX (Specialised Therapeutics PM Pty Ltd)
Product name
NERLYNX
Date registered
Evaluation commenced
Decision date
Approval time
200 working days (255)
Active ingredients
neratinib maleate
Registration type
NCE/NBE
Indication
NERLYNX (film coated tablets) is indicated for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab based therapy.