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FYZANT Icatibant (as acetate) 30mg/3mL solution for injection pre-filled syringe - TGA Drug Approval Details
Approvals
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TGA
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FYZANT Icatibant (as acetate) 30mg/3mL solution for injection pre-filled syringe
Approved
STANDARD
FYZANT Icatibant (as acetate) 30mg/3mL solution for injection pre-filled syringe
Juno Pharmaceuticals Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
May 30, 2025
Approval ID
0138ebd205103316
Company
Juno Pharmaceuticals Pty Ltd
Type
Standard
Approval Details
Approval Id
0138ebd205103316
Product Name
FYZANT Icatibant (as acetate) 30mg/3mL solution for injection pre-filled syringe
Artg Id
355650
Artg Name
FYZANT Icatibant (as acetate) 30mg/3mL solution for injection pre-filled syringe
Sponsor
Juno Pharmaceuticals Pty Ltd
Company Detail Path
/organization/juno-pharmaceuticals-pty-ltd
Artg Date
2022-03-18
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Consumer Medicine Info
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2022-CMI-02195-1
Product Information
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2022-PI-01528-1
Active Ingredients
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
May 30, 2025
Approval ID
0138ebd205103316
Type
Standard
Back to TGA Approvals