EMEA-001665-PIP01-14-M06
Key facts
Invented name |
Zynteglo
|
Active substance |
betibeglogene autotemcel
|
Therapeutic area |
Haematology-Hemostaseology
|
Decision number |
P/0175/2022
|
PIP number |
EMEA-001665-PIP01-14-M06
|
Pharmaceutical form(s) |
Dispersion for infusion
|
Condition(s) / indication(s) |
Treatment of β-thalassaemia
|
Route(s) of administration |
Intravenous use
|
Contact for public enquiries |
bluebird bio (Netherlands) B.V.
E-mail: patient.advocacy@bluebirdbio.com |
Decision type |
RPM: decision refers to a refusal on the application for modification of an agreed PIP
|