EMEA-000753-PIP02-16
Key facts
Invented name |
Obizur
|
Active substance |
susoctocog alfa
|
Therapeutic area |
Haematology-Hemostaseology
|
Decision number |
EMEA-000753-PIP02-16
|
PIP number |
EMEA-000753-PIP02-16
|
Pharmaceutical form(s) |
Powder and solvent for solution for injection
|
Condition(s) / indication(s) |
Treatment of congenital haemophilia A with antibodies (inhibitors) to human factor VIII
|
Route(s) of administration |
Intravenous use
|
Contact for public enquiries |
Baxalta Innovations GmbH
E-mail: medinfoEMEA@takeda.com |
Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|