Our approved medicines
Over the past 20 years, Vertex has been relentless in its pursuit of medical research to develop innovative therapies for cystic fibrosis (CF) – a rare, life-limiting, genetic disease, affecting approximately 3,500 Australians and 540 New Zealanders.
Locally, Vertex supports Quality Use of Medicines (QUM) principles to educate on the appropriate, safe and effective prescribing and administration of our medicines.
The Product Information (PI) in Australia, or Data Sheet in New Zealand, provides healthcare professionals with a summary of the scientific information relevant to the safe and effective use of a prescription medicine.
The Consumer Medicines Information (CMI) in Australia and New Zealand contains non-technical information on the safe and effective use of a prescription medicine, written specifically for patients and consumers with the aim of supporting better health outcomes.
To access the PI/Data Sheet or CMI for each of our medicines registered for use in Australia and New Zealand, please click the relevant links below.
Australia
KALYDECO® (ivacaftor)
For healthcare professionals: Product Information (PI)
For patients: Consumer Medicines Information (CMI)
ORKAMBI® (lumacaftor/ivacaftor)
For healthcare professionals: Product Information (PI)
For patients: Consumer Medicines Information (CMI)
SYMDEKO® (tezacaftor/ivacaftor and ivacaftor)
For healthcare professionals: Product Information (PI)
For patients: Consumer Medicines Information (CMI)
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TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor)
For healthcare professionals: Product Information (PI)
For patients: Consumer Medicines Information (CMI)
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New Zealand
KALYDECO® (ivacaftor)
For healthcare professionals: Data Sheet
For patients: Consumer Medicines Information (CMI)
TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor)
For healthcare professionals: Data Sheet
For patients: Consumer Medicines Information (CMI)
▲ This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.