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VITRAKVI larotrectinib (as sulfate) 100 mg hard capsule bottle - TGA Drug Approval Details
Approvals
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TGA
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VITRAKVI larotrectinib (as sulfate) 100 mg hard capsule bottle
Approved
STANDARD
VITRAKVI larotrectinib (as sulfate) 100 mg hard capsule bottle
Bayer Australia Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
1fef0e28835259c4
Company
Bayer Australia Ltd
Type
Standard
Approval Details
Approval Id
1fef0e28835259c4
Product Name
VITRAKVI larotrectinib (as sulfate) 100 mg hard capsule bottle
Artg Id
320238
Artg Name
VITRAKVI larotrectinib (as sulfate)100 mg hard capsule bottle
Sponsor
Bayer Australia Ltd
Company Detail Path
/organization/bayer-australia-ltd
Artg Date
2020-09-07
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
REP
Consumer Medicine Info
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2023-CMI-02431-1
Product Information
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2020-PI-02289-1
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
1fef0e28835259c4
Type
Standard
Back to TGA Approvals