EMEA-001974-PIP01-16-M02

Key facts

Active substance
Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0400/2018
PIP number
EMEA-001974-PIP01-16-M02
Pharmaceutical form(s)
Dispersion 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 Limited

Tel. +44 2033846700
E-mail: regulatory@orchard-tx.com

 

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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