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TALZENNA (Pfizer Australia Pty Ltd)
Product name
TALZENNA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
198 working days (255)
Active ingredients
talazoparib tosilate
Registration type
NCE/NBE
Indication
TALZENNA (capsules) is indicated for the treatment of patients with a deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA) mutation according to a validated diagnostic test, who have human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer.