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In this section: Cellular & Gene Therapy Products

IMLYGIC

STN: 125518
Proper Name: talimogene laherparepvec
Tradename: IMLYGIC
Manufacturer: BioVex Inc., a wholly owned subsidiary of Amgen, Inc.
Indication:

For the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.

Product Information

Package Insert - IMLYGIC
Medication Guide - IMLYGIC

Supporting Documents

February 10, 2023 Approval Letter - IMLYGIC
June 30, 2022 Approval Letter (Replacement) - IMLYGIC
June 14, 2022 Approval Letter - IMLYGIC
December 8, 2021 Approval Letter - IMLYGIC
Approval History, Letters, Reviews, and Related Documents - IMLYGIC
Supporting Documents older than three years - IMLYGIC

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