Approvals/TGA/ZEPZELCA lurbinectedin 4 mg powder for solution for infusion 1 vial per carton

Approved

STANDARD

ZEPZELCA lurbinectedin 4 mg powder for solution for infusion 1 vial per carton

Specialised Therapeutics Pharma Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: ac378f626ebb5a72
Product Name: ZEPZELCA lurbinectedin 4 mg powder for solution for infusion 1 vial per carton
Artg Id: 335536
Artg Name: ZEPZELCA lurbinectedin 4 mg powder for solution for infusion 1 vial per carton
Sponsor: Specialised Therapeutics Pharma Pty Ltd
Company Detail Path: /organization/specialised-therapeutics-pharma-pty-ltd
Artg Date: 2021-09-13
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: REP
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/4c3c3a56238952274b7fe0247275b010.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/eb59ef2a229f06a19c9c10f795361d1a.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

ac378f626ebb5a72

Type

Standard