EMEA-001792-PIP01-15

Key facts

Active substance
Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with lentiviral vector that encodes for the human Wiskott Aldrich Syndrome (WAS) cDNA sequence
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0083/2016
PIP number
EMEA-001792-PIP01-15
Pharmaceutical form(s)
Dispersion for infusion
Condition(s) / indication(s)
Treatment of Wiskott Aldrich Syndrome
Route(s) of administration
Intravenous use
Contact for public enquiries
GlaxoSmithKline Trading Services Limited


Tel. +44 (0)20 8990 3836
E-mail: eu.paediatric-plans@gsk.com

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Compliance procedure number
EMEA-001792-PIP01-15
Compliance opinion date
24/03/2017
Compliance outcome
positive

Decision

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