EMEA-001289-PIP01-12-M01

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Overview

Product details for -
Invented name-
Active substance

Autologous CD34+ cells transduced ex-vivo with retroviral vector (GIADAl) containing human adenosine deaminase gene from cDNA

Decision numberP/0190/2014
PIP numberEMEA-001289-PIP01-12-M01
Pharmaceutical form(s)Cell suspension for infusion
Condition(s)/indication(s)

Treatment of severe combined immunodeficiency due to adenosine deaminase deficiency

Route(s) of administrationIntravenous use
PIP applicant

GlaxoSmithKline Trading Services Limited
E-mail: eu.paediatric-plans@gsk.com
United Kingdom
Tel. + 44 (0)20 8990 3650
Fax + 44 (0)20 8990 3511

Decision typePM: decision on the application for modification of an agreed PIP
Compliance check procedure numberEMEA-C-001289-PIP01-12-M01
Compliance check opinion date14/11/2014
Compliance check outcomePositive

Decision