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
|