EMEA-001665-PIP02-17

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

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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 (PDF/308.71 KB)

Adopted

First published: 08/11/2019
EMA/369846/2019

Related content

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Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human βA-T87Q-globin gene - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision (PDF/176.17 KB)

First published: 09/02/2022

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