EMEA-001329-PIP02-13 - paediatric investigation plan

expanded autologous bone marrow-derived osteoblastic cells

Key facts

• Active substance:
  expanded autologous bone marrow-derived osteoblastic cells
• Therapeutic area:
  Other
• Decision number:
  P/0164/2014
• PIP number:
  EMEA-001329-PIP02-13
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Treatment of non-traumatic osteonecrosis
• Route(s) of administration:
  Intraosseous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  25/06/2014
• Compliance check done:
  No

Decision

P/0164/2014: EMA decision of 25 June 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for expanded autologous bone marrow-derived osteoblastic cel...

Adopted Reference Number: EMA/268706/2014