EMEA-000115-PIP01-07-M09
Key facts
Invented name |
Translarna
|
Active substance |
Ataluren
|
Therapeutic area |
Neurology
|
Decision number |
P/0393/2017
|
PIP number |
EMEA-000115-PIP01-07-M09
|
Pharmaceutical form(s) |
Granules for oral suspension
|
Condition(s) / indication(s) |
Treatment of dystrophinopathy
|
Route(s) of administration |
Oral use
|
Contact for public enquiries |
PTC Therapeutics International Limited
Tel. +353 19068700
E-mail: medinfo@ptcbio.com |
Decision type |
PM: decision on the application for modification of an agreed PIP
|