TGA Approval

SKYCLARYS omaveloxolone 50 mg capsule bottle (453725)

ARTG ID

453725

ARTG Name

SKYCLARYS omaveloxolone 50 mg capsule bottle

Sponsor

Biogen Australia Pty Ltd

ARTG Date

June 26, 2025

Registration Type

Medicine

Therapeutic Good Type

Medicine

Licence Status

Active

Licence Category

Registered

Sponsor Information

Sponsor Name

Sponsor Item Name

BIOGEN AUSTRALIA PTY LTD

https://medical-cdn.nocode.com/drug_tga/820a8da6fe0db039714f3331c899cbce.pdf

Ingredient Name

omaveloxolone

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SKYCLARYS omaveloxolone 50 mg capsule bottle (453725) - TGA 批准文号 | MedPath