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
|