TGA Approval

SPINRAZA nusinersen (as heptadecasodium) 12 mg/ 5 mL solution for injection vial (282522)

ARTG ID

282522

ARTG Name

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

Sponsor

Biogen Australia Pty Ltd

ARTG Date

November 3, 2017

Registration Type

Medicine

Therapeutic Good Type

Medicine

Licence Status

Active

Licence Category

Registered

Sponsor Information

Sponsor Name

Sponsor Item Name

BIOGEN AUSTRALIA PTY LTD

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2017-CMI-02574-1

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2017-PI-02575-1

Ingredient Name

nusinersen heptadecasodium

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SPINRAZA nusinersen (as heptadecasodium) 12 mg/ 5 mL solution for injection vial (282522) - TGA 批准文号 | MedPath