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BLINCYTO blinatumomab (rch) 38.5 microgram powder for injection vial with Intravenous (IV) solution stabiliser - TGA Drug Approval Details
Approvals
/
TGA
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BLINCYTO blinatumomab (rch) 38.5 microgram powder for injection vial with Intravenous (IV) solution stabiliser
Approved
STANDARD
BLINCYTO blinatumomab (rch) 38.5 microgram powder for injection vial with Intravenous (IV) solution stabiliser
Amgen Australia Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
5144d96599033d5c
Company
Amgen Australia Pty Ltd
Type
Standard
Approval Details
Approval Id
5144d96599033d5c
Product Name
BLINCYTO blinatumomab (rch) 38.5 microgram powder for injection vial with Intravenous (IV) solution stabiliser
Artg Id
232805
Artg Name
BLINCYTO blinatumomab (rch) 38.5 microgram powder for injection vial with Intravenous (IV) solution stabiliser
Sponsor
Amgen Australia Pty Ltd
Company Detail Path
/organization/amgen-australia-pty-ltd
Artg Date
2015-11-09
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-2016-CMI-01304-1
Product Information
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2015-PI-02791-1
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
5144d96599033d5c
Type
Standard
Back to TGA Approvals