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SKYCLARYS omaveloxolone 50 mg capsule bottle - TGA Drug Approval Details
Approvals
/
TGA
/
SKYCLARYS omaveloxolone 50 mg capsule bottle
Approved
STANDARD
SKYCLARYS omaveloxolone 50 mg capsule bottle
Biogen Australia Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Jul 1, 2025
Approval ID
3f03646306ec23a5
Company
Biogen Australia Pty Ltd
Type
Standard
Approval Details
Approval Id
3f03646306ec23a5
Product Name
SKYCLARYS omaveloxolone 50 mg capsule bottle
Artg Id
453725
Artg Name
SKYCLARYS omaveloxolone 50 mg capsule bottle
Sponsor
Biogen Australia Pty Ltd
Company Detail Path
/organization/biogen-australia-pty-ltd
Artg Date
2025-06-26
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Product Information
https://medical-cdn.nocode.com/drug_tga/820a8da6fe0db039714f3331c899cbce.pdf
Active Ingredients
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Jul 1, 2025
Approval ID
3f03646306ec23a5
Type
Standard
Back to TGA Approvals