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
|