EMEA-002571-PIP01-19
Key facts
| Active substance |
Adeno-associated viral vector serotype 8 containing the human MTM1 gene (resamirigene bilparvovec)
|
| Therapeutic area |
Other
|
| Decision number |
P/0309/2020
|
| PIP number |
EMEA-002571-PIP01-19
|
| Pharmaceutical form(s) |
Solution for infusion
|
| Condition(s) / indication(s) |
Treatment of X linked myotubular myopathy
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
Astellas Pharma Europe B.V.
E-mail: regulatory.eu@astellas.com |
| Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|