Product Details for: Imlygic
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intralesional
100 MILLION PFU/ML
Single-Dose Vial
351(a)
Imlygic
Rx
002
For Injection
Intralesional
1 MILLION PFU/ML
Single-Dose Vial
351(a)
Imlygic
Rx
Proper Name
Talimogene laherparepvec
Talimogene laherparepvec
BLA Number
125518
125518
Applicant
Amgen Inc.
Amgen Inc.
Original Approval Date
October 27, 2015
October 27, 2015
Date of First Licensure