EMEA-000914-PIP01-10-M05
Key facts
| Invented name |
Alprolix
|
| Active substance |
eftrenonacog alfa
|
| Therapeutic area |
Haematology-Hemostaseology
|
| Decision number |
P/0071/2020
|
| PIP number |
EMEA-000914-PIP01-10-M05
|
| 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 |
Swedish Orphan Biovitrum AB (publ)
E-mail: medical.info@sobi.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000914-PIP01-10-M05
|
| Compliance opinion date |
24/07/2020
|
| Compliance outcome |
positive
|