EMEA-001107-PIP01-10-M04
Key facts
| Invented name |
Idelvion
|
| Active substance |
albutrepenonacog alfa
|
| Therapeutic area |
Haematology-Hemostaseology
|
| Decision number |
P/0031/2020
|
| PIP number |
EMEA-001107-PIP01-10-M04
|
| Pharmaceutical form(s) |
|
| Condition(s) / indication(s) |
Treatment of hereditary factor IX deficiency
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
CSL Behring GmbH
Tel.: +49 6421393304 |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-001107-PIP01-10-M04
|
| Compliance opinion date |
21/01/2022
|
| Compliance outcome |
negative
|