EMEA-002362-PIP02-19-M02
Key facts
| Active substance |
fidanacogene elaparvovec
|
| Therapeutic area |
Haematology-Hemostaseology
|
| Decision number |
P/0277/2022
|
| PIP number |
EMEA-002362-PIP02-19-M02
|
| Pharmaceutical form(s) |
Solution for infusion
|
| Condition(s) / indication(s) |
Treatment of congenital factor IX deficiency (haemophilia B)
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
Pfizer Europe MA EEIG
E-mail: pip_enquiries@pfizer.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|