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
|