EMEA-001448-PIP01-13-M03
Key facts
| Invented name |
Spinraza
|
| Active substance |
Nusinersen
|
| Therapeutic area |
Neurology
|
| Decision number |
P/023/2018
|
| PIP number |
EMEA-001448-PIP01-13-M03
|
| Pharmaceutical form(s) |
Solution for injection
|
| Condition(s) / indication(s) |
Treatment of spinal muscular atrophy
|
| Route(s) of administration |
Intrathecal use
|
| Contact for public enquiries |
Biogen Idec Ltd
Tel. +44 1628501014
E-mail: pip.enquiries@biogenidec.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-001448-PIP01-13-M03
|
| Compliance opinion date |
29/06/2018
|
| Compliance outcome |
positive
|