EMEA-001004-PIP01-10 - paediatric investigation plan

autologous oral mucosal epithelial cells

Key facts

• Active substance:
  autologous oral mucosal epithelial cells
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/118/2011
• PIP number:
  EMEA-001004-PIP01-10
• Pharmaceutical form(s):
  Living tissue equivalent
• Condition(s) / indication(s):
  Treatment of limbal stem cell deficiency
• Route(s) of administration:
  Ocular use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  23/05/2011
• Compliance check done:
  No

Decision

P/118/2011: EMA decision of 23 May 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for autologous oral mucosal epithelial cells, (EMEA-001004-PI...

Adopted Reference Number: EMA/338204/2011