EMEA-002341-PIP01-18-M02
Key facts
| Active substance |
Ganaxolone
|
| Therapeutic area |
Neurology
|
| Decision number |
P/0404/2021
|
| PIP number |
EMEA-002341-PIP01-18-M02
|
| Pharmaceutical form(s) |
|
| Condition(s) / indication(s) |
Treatment of cyclin-dependent kinase-like 5 deficiency disorder
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Marinus Pharmaceuticals Inc.
E-mail: regulatory@marinuspharma.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|