Approvals/TGA/SPINRAZA nusinersen (as heptadecasodium) 12 mg/5mL solution for injection vial

Approved

STANDARD

SPINRAZA nusinersen (as heptadecasodium) 12 mg/5mL solution for injection vial

Biogen Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: a1174e7e1b832ef2
Product Name: SPINRAZA nusinersen (as heptadecasodium) 12 mg/5mL solution for injection vial
Artg Id: 282522
Artg Name: SPINRAZA nusinersen (as heptadecasodium) 12 mg/ 5 mL solution for injection vial
Sponsor: Biogen Australia Pty Ltd
Company Detail Path: /organization/biogen-australia-pty-ltd
Artg Date: 2017-11-03
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2017-CMI-02574-1
Product Information: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2017-PI-02575-1

Approved

Agency

TGA

Country

🇦🇺

Approval Date

May 30, 2025

Approval ID

a1174e7e1b832ef2

Type

Standard