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Vertex Pharmaceuticals (Australia) Pty Ltd

Regulatory activities for this sponsor.

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2024

1 result(s) found, displaying 1 to 1

Kalydeco (ivacaftor)

5 November 2024

Australian Public Assessment Report (AusPAR)

Kalydeco (ivacaftor) was approved to treat cystic fibrosis in patients aged 4 months and older who have at least one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data.