EMEA-001289-PIP01-12-M01
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.
Tel. +44 (0) 20 3808 8286 |
| 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
|