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
|