EMEA-001244-PIP01-11-M02

Table of contents

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
E-mail: CDeCoster@bluebirdio.com

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

Decision

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