Key facts

Active Substance
Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human βA-T87Q-globin gene
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0234/2019
PIP number
EMEA-001665-PIP02-17
Pharmaceutical form(s)
Dispersion for infusion
Condition(s) / indication(s)
Treatment of sickle cell disease
Route(s) of administration
Intravenous use
Contact for public enquiries

Bluebird Bio France

Tel. +1 857 331 5169
E-mail: pgeoffroy@bluebirdbio.com

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date

Decision

P/0234/2019: EMA decision of 16 June 2019 on the agreement of a PIP and on the granting of a deferral and on the granting of a waiver for autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human βA-T87Q-globin gene

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