EMEA-002021-PIP01-16
Key facts
| Active substance |
rAAV8 viral vector encoding the human UGT1A1 transgene (rAAV8-hUGT1A1)
|
| Therapeutic area |
Endocrinology, -gynacology-fertility-metabolism
|
| Decision number |
P/0194/2021
|
| PIP number |
EMEA-002021-PIP01-16
|
| Pharmaceutical form(s) |
Concentrate for solution for infusion
|
| Condition(s) / indication(s) |
Treatment of Crigler-Najjar syndrome
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
GENETHON
E-mail: clinical_development@genethon.fr |
| Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|