Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Vertex Pharmaceuticals (Ireland) Limited, Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland
Kalydeco 25 mg granules in sachet.
Kalydeco 50 mg granules in sachet.
Kalydeco 75 mg granules in sachet.
| Pharmaceutical Form |
|---|
|
Granules in sachet. White to off-white granules approximately 2 mm in diameter. |
Each sachet contains 25 mg of ivacaftor.
Excipient with known effect: Each sachet contains 36.6 mg of lactose monohydrate.
Each sachet contains 50 mg of ivacaftor.
Excipient with known effect: Each sachet contains 73.2 mg of lactose monohydrate.
Each sachet contains 75 mg of ivacaftor.
Excipient with known effect: Each sachet contains 109.8 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ivacaftor |
Ivacaftor is a potentiator of the CFTR protein, i.e., in vitro ivacaftor increases CFTR channel gating to enhance chloride transport in specified gating mutations with reduced channel-open probability compared to normal CFTR. Ivacaftor also potentiated the channel-open probability of R117H-CFTR, which has both low channel-open probability (gating) and reduced channel current amplitude (conductance). |
| List of Excipients |
|---|
|
Silica, colloidal anhydrous |
Biaxially Oriented Polyethylene Terephthalate/Polyethylene/Foil/Polyethylene (BOPET/PE/Foil/PE) sachet.
Kalydeco 25 mg granules in sachet, Kalydeco 50 mg granules in sachet, and Kalydeco 75 mg granules in sachet: Pack size of 56 sachets (contains 4 individual wallets with 14 sachets per wallet).
Kalydeco 75 mg granules in sachet: Pack size of 28 sachets (contains 4 individual wallets with 7 sachets per wallet).
Vertex Pharmaceuticals (Ireland) Limited, Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland
EU/1/12/782/003
EU/1/12/782/004
EU/1/12/782/006
EU/1/12/782/009
Date of first authorisation: 23 July 2012
Date of latest renewal: 29 April 2022
| Drug | Countries | |
|---|---|---|
| KALYDECO | Austria, Australia, Brazil, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom, United States |
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