Allogeneic ex vivo expanded umbilical cord blood cells - paediatric investigation plan

Allogeneic ex vivo expanded umbilical cord blood cells

Key facts

• Active Substance:
  Allogeneic ex vivo expanded umbilical cord blood cells
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/255/2009
• PIP number:
  Allogeneic ex vivo expanded umbilical cord blood cells
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  • Treatment of acute lymphoblastic leukaemia
  • Treatment of acute myeloid leukaemia
  • Treatment of chronic myeloid leukaemia (CML)
  • Treatment of Hodgkin lymphoma
  • Treatment of myelodysplastic syndromes
  • Treatment of non-Hodgkin lymphoma
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Teva Pharma GmbH

  E-mail: [e-mail]; Country: Germany; Phone: [phone]; Fax: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  22/12/2009

Decision

P/255/2009: EMA decision of 22 December 2009 on the refusal of a Paediatric Investigation Plan and on the granting of a waiver for Allogeneic ex vivo expanded umbilical cord blood cells (EMA-000554...

AdoptedReference Number: EMA/811657/2009