TGA Approval

NUBEQA darolutamide 300 mg tablet bottle (317242)

ARTG ID

317242

ARTG Name

NUBEQA darolutamide 300 mg tablet bottle

Sponsor

Bayer Australia Ltd

ARTG Date

February 26, 2020

Registration Type

Medicine

Therapeutic Good Type

Medicine

Licence Status

Active

Licence Category

Registered

Sponsor Information

Sponsor Name

Sponsor Item Name

BAYER AUSTRALIA LTD

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2023-CMI-01415-1

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2020-PI-01276-1

Ingredient Name

darolutamide

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NUBEQA darolutamide 300 mg tablet bottle (317242) - TGA 批准文号 | MedPath