TGA Approval

KALYDECO ivacaftor 13.4 mg granules sachet (449865)

ARTG ID

449865

ARTG Name

KALYDECO ivacaftor 13.4 mg granules sachet

Sponsor

Vertex Pharmaceuticals Australia Pty Ltd

ARTG Date

February 6, 2025

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 13.4 mg granules sachet (449865) - TGA 批准文号 | MedPath