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TRACLEER bosentan 125mg (as monohydrate) tablet bottle - TGA Drug Approval Details
Approvals
/
TGA
/
TRACLEER bosentan 125mg (as monohydrate) tablet bottle
Approved
STANDARD
TRACLEER bosentan 125mg (as monohydrate) tablet bottle
Janssen-Cilag Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
May 29, 2025
Approval ID
55bb957a11f4d70f
Company
Janssen-Cilag Pty Ltd
Type
Standard
Approval Details
Approval Id
55bb957a11f4d70f
Product Name
TRACLEER bosentan 125mg (as monohydrate) tablet bottle
Artg Id
91920
Artg Name
TRACLEER bosentan 125mg (as monohydrate) tablet bottle
Sponsor
Janssen-Cilag Pty Ltd
Company Detail Path
/organization/janssen-cilag-pty-ltd
Artg Date
2002-11-20
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Consumer Medicine Info
https://medical-cdn.nocode.com/drug_tga/c6faf8b8f43d23ffcdb14a1bbb622f9a.pdf
Product Information
https://medical-cdn.nocode.com/drug_tga/cc2130c998e5b419e30f532d5443ae32.pdf
Active Ingredients
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
May 29, 2025
Approval ID
55bb957a11f4d70f
Type
Standard
Back to TGA Approvals