EMEA-000115-PIP02-09-M03
Key facts
| Invented name |
Translarna
|
| Active substance |
Ataluren
|
| Therapeutic area |
Pneumology-allergology
|
| Decision number |
P/0284/2016
|
| PIP number |
EMEA-000115-PIP02-09-M03
|
| Pharmaceutical form(s) |
Granules for oral suspension
|
| Condition(s) / indication(s) |
Treatment of cystic fibrosis
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
PTC Therapeutics International, Limited
|
| Decision type |
PM: decision on the application for modification of an agreed PIP
|