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ENHERTU (AstraZeneca Pty Ltd)
Product name
ENHERTU
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
235 (255 working days)
Active ingredients
trastuzumab deruxtecan
Registration type
EOI
Indication
ENHERTU is now also indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior systemic treatment and who have no satisfactory alternative treatment options.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration