EMEA-001933-PIP01-16

Key facts

Active substance
Autologous CD34+ cells transduced with lentiviral vector encoding the human beta-globin gene
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0033/2017
PIP number
EMEA-001933-PIP01-16
Pharmaceutical form(s)
Dispersion for injection
Condition(s) / indication(s)
Treatment of beta-thalassemia
Route(s) of administration
Intraosseous use
Contact for public enquiries
Fondazione Telethon
Ireland
Tel. +44 (0)20 3384 6700
Fax: +44(0)20 8990 3511
E-mail: regulatory@orchard-tx.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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