Product Details for: Ziihera
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
300MG
Single-Dose Vial
351(a)
Ziihera
Rx
Proper Name
zanidatamab-hrii
zanidatamab-hrii
BLA Number
761416
761416
Applicant
Jazz Pharmaceuticals Ireland Limited
Jazz Pharmaceuticals Ireland Limited
Original Approval Date
November 20, 2024
November 20, 2024
Date of First Licensure