Key facts

Invented name
Strimvelis
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

Orchard Therapeutics (Netherlands) B.V.

regulatory@orchard-tx.com

Tel. +44 (0) 20 3808 8286

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-001289-PIP01-12-M01
Compliance opinion date
Compliance outcome
Positive

Decision

P/0190/2014: EMA decision of 6 August 2014 on the acceptance of a modification of an agreed paediatric investigation plan for autologous CD34+ Cells Transduced ex-vivo with Retroviral Vector (GIADAl) Containing Human Ade...

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