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XYNTHA moroctocog alfa (rch) 1000IU powder for injection plus diluent syringe - TGA Drug Approval Details
Approvals
/
TGA
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XYNTHA moroctocog alfa (rch) 1000IU powder for injection plus diluent syringe
Approved
STANDARD
XYNTHA moroctocog alfa (rch) 1000IU powder for injection plus diluent syringe
Pfizer Australia Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
b820290b6d709618
Company
Pfizer Australia Pty Ltd
Type
Standard
Approval Details
Approval Id
b820290b6d709618
Product Name
XYNTHA moroctocog alfa (rch) 1000IU powder for injection plus diluent syringe
Artg Id
161716
Artg Name
XYNTHA moroctocog alfa (rch) 1000IU powder for injection plus diluent syringe
Sponsor
Pfizer Australia Pty Ltd
Company Detail Path
/organization/pfizer-australia-pty-ltd
Artg Date
2009-06-26
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-2010-CMI-06727-3
Product Information
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2010-PI-06728-3
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
b820290b6d709618
Type
Standard
Back to TGA Approvals