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NERLYNX neratinib (as maleate) 40 mg film coated tablets - TGA Drug Approval Details
Approvals
/
TGA
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NERLYNX neratinib (as maleate) 40 mg film coated tablets
Approved
STANDARD
NERLYNX neratinib (as maleate) 40 mg film coated tablets
Specialised Therapeutics PM Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
566736150c4b6529
Company
Specialised Therapeutics PM Pty Ltd
Type
Standard
Approval Details
Approval Id
566736150c4b6529
Product Name
NERLYNX neratinib (as maleate) 40 mg film coated tablets
Artg Id
301129
Artg Name
NERLYNX neratinib (as maleate) 40 mg film coated tablets
Sponsor
Specialised Therapeutics PM Pty Ltd
Company Detail Path
/organization/specialised-therapeutics-pm-pty-ltd
Artg Date
2019-03-15
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Consumer Medicine Info
https://medical-cdn.nocode.com/drug_tga/0cff6060ff20ae451863f74ab1a65f36.pdf
Product Information
https://medical-cdn.nocode.com/drug_tga/5905c49bcb5c3c1f8288d78295d49bd2.pdf
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
566736150c4b6529
Type
Standard
Back to TGA Approvals