EMEA-001665-PIP01-14-M06 - paediatric investigation plan

betibeglogene autotemcel
PIPHuman

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
Tel. +1 3394999300

Decision type
RPM: decision refers to a refusal on the application for modification of an agreed PIP
Decision date

Decision

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