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Kesimpta-Ofatumumab 20 mg/0.4mL solution for injection pre-filled pen - TGA Drug Approval Details
Approvals
/
TGA
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Kesimpta-Ofatumumab 20 mg/0.4mL solution for injection pre-filled pen
Approved
STANDARD
Kesimpta-Ofatumumab 20 mg/0.4mL solution for injection pre-filled pen
Novartis Pharmaceuticals Australia Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
May 30, 2025
Approval ID
fb8b5567ddd46d5a
Company
Novartis Pharmaceuticals Australia Pty Ltd
Type
Standard
Approval Details
Approval Id
fb8b5567ddd46d5a
Product Name
Kesimpta-Ofatumumab 20 mg/0.4mL solution for injection pre-filled pen
Artg Id
330601
Artg Name
Kesimpta-Ofatumumab 20 mg/0.4mL solution for injection pre-filled pen
Sponsor
Novartis Pharmaceuticals Australia Pty Ltd
Company Detail Path
/organization/novartis-pharmaceuticals-australia-pty-ltd
Artg Date
2021-03-04
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Consumer Medicine Info
https://medical-cdn.nocode.com/drug_tga/0d803ec8f15f059b2f0bc40c1250e687.pdf
Product Information
https://medical-cdn.nocode.com/drug_tga/125fa11968272d0c06340c26e3ab6125.pdf
Active Ingredients
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
May 30, 2025
Approval ID
fb8b5567ddd46d5a
Type
Standard
Back to TGA Approvals