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GAZYVA obinutuzumab (rch) 1000 mg/40 mL concentrate solution for infusion vial - TGA Drug Approval Details
Approvals
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TGA
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GAZYVA obinutuzumab (rch) 1000 mg/40 mL concentrate solution for infusion vial
Approved
STANDARD
GAZYVA obinutuzumab (rch) 1000 mg/40 mL concentrate solution for infusion vial
Roche Products Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
May 30, 2025
Approval ID
8e8ebff52500c0f1
Company
Roche Products Pty Ltd
Type
Standard
Approval Details
Approval Id
8e8ebff52500c0f1
Product Name
GAZYVA obinutuzumab (rch) 1000 mg/40 mL concentrate solution for infusion vial
Artg Id
210562
Artg Name
GAZYVA obinutuzumab (rch) 1000 mg/40 mL concentrate solution for infusion vial
Sponsor
Roche Products Pty Ltd
Company Detail Path
/organization/roche-products-pty-ltd
Artg Date
2014-05-15
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Consumer Medicine Info
https://medical-cdn.nocode.com/drug_tga/a4ca40355d613fa024b6bae53768a06a.pdf
Product Information
https://medical-cdn.nocode.com/drug_tga/8760a1b1961a72f9e6e7bffe02b95a3d.pdf
Active Ingredients
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
May 30, 2025
Approval ID
8e8ebff52500c0f1
Type
Standard
Back to TGA Approvals