TGA Approval

CALQUENCE acalabrutinib (as maleate) 100 mg film-coated tablet blister pack (377410)

ARTG ID

377410

ARTG Name

CALQUENCE acalabrutinib (as maleate) 100 mg film-coated tablet blister pack

Sponsor

AstraZeneca Pty Ltd

ARTG Date

October 13, 2022

Registration Type

Medicine

Therapeutic Good Type

Medicine

Licence Status

Active

Licence Category

Registered - Prescription Injectable

Sponsor Information

Sponsor Name

Sponsor Item Name

ASTRAZENECA PTY LTD

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2023-CMI-01611-1

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2022-PI-02150-1

Ingredient Name

acalabrutinib maleate monohydrate

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CALQUENCE acalabrutinib (as maleate) 100 mg film-coated tablet blister pack (377410) - TGA 批准文号 | MedPath