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XELABINE capecitabine 500 mg film-coated tablet blister pack - TGA Drug Approval Details
Approvals
/
TGA
/
XELABINE capecitabine 500 mg film-coated tablet blister pack
Approved
STANDARD
XELABINE capecitabine 500 mg film-coated tablet blister pack
Viatris Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
45ea9512ea2fa4cf
Company
Viatris Pty Ltd
Type
Standard
Approval Details
Approval Id
45ea9512ea2fa4cf
Product Name
XELABINE capecitabine 500 mg film-coated tablet blister pack
Artg Id
213045
Artg Name
XELABINE capecitabine 500 mg film-coated tablet blister pack
Sponsor
Viatris Pty Ltd
Company Detail Path
/organization/viatris-pty-ltd
Artg Date
2014-07-22
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-2017-CMI-02397-1
Product Information
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2017-PI-02396-1
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
45ea9512ea2fa4cf
Type
Standard
Back to TGA Approvals