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XOLAIR omalizumab (rch) 150 mg solution for injection pre-filled pen - TGA Drug Approval Details
Approvals
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TGA
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XOLAIR omalizumab (rch) 150 mg solution for injection pre-filled pen
Approved
STANDARD
XOLAIR omalizumab (rch) 150 mg solution for injection pre-filled pen
Novartis Pharmaceuticals Australia Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
ef15fc2f44d3b79c
Company
Novartis Pharmaceuticals Australia Pty Ltd
Type
Standard
Approval Details
Approval Id
ef15fc2f44d3b79c
Product Name
XOLAIR omalizumab (rch) 150 mg solution for injection pre-filled pen
Artg Id
429511
Artg Name
XOLAIR omalizumab (rch) 150 mg solution for injection pre-filled pen
Sponsor
Novartis Pharmaceuticals Australia Pty Ltd
Company Detail Path
/organization/novartis-pharmaceuticals-australia-pty-ltd
Artg Date
2024-09-04
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-05307-3
Product Information
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2009-PI-00304-3
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
ef15fc2f44d3b79c
Type
Standard
Back to TGA Approvals