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 75 mg film-coated tablets.
Kalydeco 150 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Kalydeco 75 mg film-coated tablets: Light blue, capsule-shaped film-coated tablets, printed with “V 75” in black ink on one side and plain on the other (12.7 mm × 6.8 mm in modified tablet shape). Kalydeco 150 mg film-coated tablets: Light blue, capsule-shaped film-coated tablets, printed with “V 150” in black ink on one side and plain on the other (16.5 mm × 8.4 mm in modified tablet shape). |
Each film-coated tablet contains 75 mg of ivacaftor.
Excipient with known effect: Each film-coated tablet contains 83.6 mg of lactose monohydrate.
Each film-coated tablet contains 150 mg of ivacaftor.
Excipient with known effect: Each film-coated tablet contains 167.2 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 |
|---|
|
Tablet core: Cellulose, microcrystalline Tablet film coat: Polyvinyl alcohol Printing ink: Shellac |
Thermoform (PolyChloroTriFluoroEthylene [PCTFE]/foil) blister or a High-Density PolyEthylene (HDPE) bottle with a polypropylene child-resistant closure, foil-lined induction seal and molecular sieve desiccant.
Kalydeco 75 mg film-coated tablets:
The following pack sizes are available:
Kalydeco 150 mg film-coated tablets:
The following pack sizes are available:
Not all pack sizes may be marketed
Vertex Pharmaceuticals (Ireland) Limited, Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland
EU/1/12/782/001
EU/1/12/782/002
EU/1/12/782/005
EU/1/12/782/007
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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