EMEA-001969-PIP01-16 - paediatric investigation plan

allogeneic human neural stem cells genetically modified to express c-MycERTAM, a c-Myc and modified oestrogen receptor fusion protein (CTX0E03)

Key facts

• Active Substance:
  allogeneic human neural stem cells genetically modified to express c-MycERTAM, a c-Myc and modified oestrogen receptor fusion protein (CTX0E03)
• Therapeutic area:
  Neurology
• Decision number:
  P/0246/2016
• PIP number:
  EMEA-001969-PIP01-16
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Treatment of cerebral infarction
• Route(s) of administration:
  Intracerebral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/09/2016

Decision

P/0246/2016: EMA decision of 12 September 2016 on the granting of a product specific waiver for allogeneic human neural stem cells genetically modified to express c-MycERTAM, a c-Myc and modified oestrogen receptor fusi...

AdoptedReference Number: EMA/557965/2016