EMEA-001289-PIP01-12-M01

Key facts

Invented name
Active substance
Autologous CD34+ cells transduced ex-vivo with retroviral vector (GIADAl) containing human adenosine deaminase gene from cDNA
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0190/2014
PIP number
EMEA-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 administration
Intravenous use
Contact for public enquiries
GlaxoSmithKline Trading Services Limited
E-mail: regulatory@orchard-tx.com
United Kingdom
Tel. +44 (0) 20 3384 6700
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-001289-PIP01-12-M01
Compliance opinion date
14/11/2014
Compliance outcome
positive

Decision

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