EMEA-001531-PIP01-13-M04
Key facts
| Invented name |
Hetlioz
|
| Active substance |
tasimelteon
|
| Therapeutic area |
Neurology
|
| Decision number |
P/0215/2018
|
| PIP number |
EMEA-001531-PIP01-13-M04
|
| Pharmaceutical form(s) |
|
| Condition(s) / indication(s) |
Treatment of non-24-hour sleep-wake disorder in the totally blind
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Vanda Pharmaceuticals Ltd
E-mail: gunther.birznieks@vandapharma.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|