EMEA-001139-PIP01-11-M02
Key facts
| Invented name |
Rixubis
|
| Active substance |
Nonacog alfa
|
| Therapeutic area |
Haematology-Hemostaseology
|
| Decision number |
P/0021/2016
|
| PIP number |
EMEA-001139-PIP01-11-M02
|
| Pharmaceutical form(s) |
Powder and solvent for solution for injection
|
| Condition(s) / indication(s) |
Treatment of haemophilia B (congenital factor IX deficiency)
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
Baxalta Innovations GmbH
|
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-001139-PIP01-11-M02
|
| Compliance opinion date |
29/06/2018
|
| Compliance outcome |
positive
|