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RYSTIGGO rozanolixizumab 140 mg/mL solution for injection for infusion vial - TGA Drug Approval Details
Approvals
/
TGA
/
RYSTIGGO rozanolixizumab 140 mg/mL solution for injection for infusion vial
Approved
STANDARD
RYSTIGGO rozanolixizumab 140 mg/mL solution for injection for infusion vial
UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
7971ae181b0fea55
Company
UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia
Type
Standard
Approval Details
Approval Id
7971ae181b0fea55
Product Name
RYSTIGGO rozanolixizumab 140 mg/mL solution for injection for infusion vial
Artg Id
427684
Artg Name
RYSTIGGO rozanolixizumab 140 mg/mL solution for injection for infusion vial
Sponsor
UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia
Company Detail Path
/organization/ucb-australia-pty-ltd
Artg Date
2025-02-07
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Consumer Medicine Info
https://medical-cdn.nocode.com/drug_tga/1b03835b781487686085b9f060ed4e52.pdf
Product Information
https://medical-cdn.nocode.com/drug_tga/ca424e37f8da16756945afefdf6ec3c4.pdf
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
7971ae181b0fea55
Type
Standard
Back to TGA Approvals