EMEA-000731-PIP01-09-M03
Key facts
Invented name |
Refixia
|
Active substance |
Nonacog beta pegol
|
Therapeutic area |
Haematology-Hemostaseology
|
Decision number |
P/0139/2019
|
PIP number |
EMEA-000731-PIP01-09-M03
|
Pharmaceutical form(s) |
Powder and solvent for solution for injection
|
Condition(s) / indication(s) |
Treatment of hereditary factor IX deficiency
|
Route(s) of administration |
Intravenous use
|
Contact for public enquiries |
Novo Nordisk A/S
E-mail: paediatrics@novonordisk.com |
Decision type |
PM: decision on the application for modification of an agreed PIP
|
Compliance procedure number |
EMEA-C-000731-PIP01-09-M03
|
Compliance opinion date |
15/11/2019
|
Compliance outcome |
positive
|