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
|