EMEA-001296-PIP01-12-M04
Key facts
Invented name |
Adynovi
|
Active substance |
rurioctocog alfa pegol
|
Therapeutic area |
Haematology-Hemostaseology
|
Decision number |
P/0302/2021
|
PIP number |
EMEA-001296-PIP01-12-M04
|
Pharmaceutical form(s) |
Powder and solvent for solution for injection
|
Condition(s) / indication(s) |
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency)
|
Route(s) of administration |
Intravenous use
|
Contact for public enquiries |
Baxalta Innovations GmbH
E-mail: medinfoEMEA@takeda.com |
Decision type |
PM: decision on the application for modification of an agreed PIP
|