EMEA-000335-PIP01-08-M14
Key facts
| Invented name |
Kalydeco
|
| Active substance |
ivacaftor
|
| Therapeutic area |
Other
|
| Decision number |
P/0353/2018
|
| PIP number |
EMEA-000335-PIP01-08-M14
|
| Pharmaceutical form(s) |
|
| Condition(s) / indication(s) |
Treatment of cystic fibrosis
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Vertex Pharmaceuticals (Europe) Limited
Tel. +1 8776348789 |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|