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
|