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
|