EMEA-000428-PIP01-08-M03
Key facts
| Invented name |
NovoEight
|
| Active substance |
turoctocog alpha
|
| Therapeutic area |
Haematology-Hemostaseology
|
| Decision number |
P/0207/2016
|
| PIP number |
EMEA-000428-PIP01-08-M03
|
| Pharmaceutical form(s) |
Powder and solvent for solution for injection
|
| Condition(s) / indication(s) |
Treatment of hereditary factor-VIII deficiency
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
Novo Nordisk A/S
Denmark |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000428-PIP01-08-M03
|
| Compliance opinion date |
26/04/2019
|
| Compliance outcome |
positive
|