EMEA-001244-PIP01-11-M02
Key facts
| Active substance |
autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ATP-binding cassette, sub-family D (ALD), member 1 (ABCD1) from cDNA
|
| Therapeutic area |
Neurology
|
| Decision number |
P/0290/2018
|
| PIP number |
EMEA-001244-PIP01-11-M02
|
| Pharmaceutical form(s) |
Dispersion for infusion
|
| Condition(s) / indication(s) |
Treatment of adrenoleukodystrophy
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
Bluebird bio France
Tel. +1 41 415615437 |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-001244-PIP01-11-M02
|
| Compliance opinion date |
04/09/2020
|
| Compliance outcome |
positive
|