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ESBRIET pirfenidone 534 mg film-coated tablet bottle - TGA Drug Approval Details
Approvals
/
TGA
/
ESBRIET pirfenidone 534 mg film-coated tablet bottle
Approved
STANDARD
ESBRIET pirfenidone 534 mg film-coated tablet bottle
Roche Products Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
531c03b6580b5cd9
Company
Roche Products Pty Ltd
Type
Standard
Approval Details
Approval Id
531c03b6580b5cd9
Product Name
ESBRIET pirfenidone 534 mg film-coated tablet bottle
Artg Id
282526
Artg Name
ESBRIET pirfenidone 534 mg film-coated tablet bottle
Sponsor
Roche Products Pty Ltd
Company Detail Path
/organization/roche-products-pty-ltd
Artg Date
2017-10-25
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Consumer Medicine Info
https://medical-cdn.nocode.com/drug_tga/622ca23e264edd4e2d5cc5e81061ca11.pdf
Product Information
https://medical-cdn.nocode.com/drug_tga/38f4c41940901bc16dc7d9e0b89b696c.pdf
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
531c03b6580b5cd9
Type
Standard
Back to TGA Approvals