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KALYDECO (Vertex Pharmaceuticals Australia Pty Ltd)

Product name
Date registered
Evaluation commenced
Decision date
Approval time
193 (255 working days)
Active ingredients
Registration type

KALYDECO is indicated for the treatment of cystic fibrosis (CF) 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(see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE, and Section 5.1 PHARMACODYNAMIC PROPERTIES).

Registration process

Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.

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