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
|