EMEA-002397-PIP01-18-M02
Key facts
| Invented name |
Kesimpta
|
| Active substance |
Ofatumumab
|
| Therapeutic area |
Neurology
|
| Decision number |
P/0121/2022
|
| PIP number |
EMEA-002397-PIP01-18-M02
|
| Pharmaceutical form(s) |
Solution for injection
|
| Condition(s) / indication(s) |
Treatment of multiple sclerosis
|
| Route(s) of administration |
Subcutaneous use
|
| Contact for public enquiries |
Novartis Europharm Limited
|
| Decision type |
PM: decision on the application for modification of an agreed PIP
|