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
Switzerland |
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
|