TGA Approval

KALYDECO ivacaftor 25 mg granules sachet (342815)

ARTG ID

342815

ARTG Name

KALYDECO ivacaftor 25 mg granules sachet

Sponsor

Vertex Pharmaceuticals Australia Pty Ltd

ARTG Date

September 24, 2021

Registration Type

Medicine

Therapeutic Good Type

Medicine

Licence Status

Active

Licence Category

Registered

Sponsor Information

Sponsor Name

Sponsor Item Name

VERTEX PHARMACEUTICALS (AUSTRALIA) PTY. LTD.

https://medical-cdn.nocode.com/drug_tga/0cad3bc1b349c90e85b39e154de1746a.pdf

https://medical-cdn.nocode.com/drug_tga/fd45d50a92c5a92b2832d7598a9c5583.pdf

Ingredient Name

ivacaftor

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KALYDECO ivacaftor 25 mg granules sachet (342815) - TGA 批准文号 | MedPath