EMEA-002168-PIP01-17-M03
Key facts
Invented name |
Zolgensma
|
Active substance |
onasemnogene abeparvovec
|
Therapeutic area |
Neurology
|
Decision number |
P/0379/2020
|
PIP number |
EMEA-002168-PIP01-17-M03
|
Pharmaceutical form(s) |
Solution for injection/infusion
|
Condition(s) / indication(s) |
Treatment of spinal muscular atrophy
|
Route(s) of administration |
|
Contact for public enquiries |
AveXis EU Limited
E-mail: medinfo.emea@avexis.com |
Decision type |
PM: decision on the application for modification of an agreed PIP
|