EMEA-000709-PIP01-09-M05
Key facts
| Invented name |
Inovelon
|
| Active substance |
Rufinamide
|
| Therapeutic area |
Neurology
|
| Decision number |
P/0116/2016
|
| PIP number |
EMEA-000709-PIP01-09-M05
|
| Pharmaceutical form(s) |
|
| Condition(s) / indication(s) |
Treatment of Lennox-Gastaut syndrome
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Eisai Limited
|
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000709-PIP01-09-M05
|
| Compliance opinion date |
16/09/2016
|
| Compliance outcome |
positive
|