EMEA-002070-PIP01-16-M06
Key facts
Invented name |
Evrysdi
|
Active substance |
Risdiplam (RO7034067)
|
Therapeutic area |
Neurology
|
Decision number |
P/0470/2021
|
PIP number |
EMEA-002070-PIP01-16-M06
|
Pharmaceutical form(s) |
Powder for oral solution
|
Condition(s) / indication(s) |
Treatment of spinal muscular atrophy
|
Route(s) of administration |
Oral use
|
Contact for public enquiries |
Roche Registration GmbH
Tel. +41 616879411 |
Decision type |
PM: decision on the application for modification of an agreed PIP
|