EMEA-001215-PIP01-11-M07
Key facts
Invented name |
Afstyla
|
Active substance |
lonoctocog alfa
|
Therapeutic area |
Haematology-Hemostaseology
|
Decision number |
P/0329/2019
|
PIP number |
EMEA-001215-PIP01-11-M07
|
Pharmaceutical form(s) |
Powder and solvent for solution for injection
|
Condition(s) / indication(s) |
Haemophilia A (congenital Factor VIII deficiency)
|
Route(s) of administration |
Intravenous use
|
Contact for public enquiries |
CSL Behring GmbH
|
Decision type |
PM: decision on the application for modification of an agreed PIP
|
Compliance procedure number |
EMEA-C-001215-PIP01-11-M07
|
Compliance opinion date |
10/09/2021
|
Compliance outcome |
positive
|