EMEA-001082-PIP02-11-M03 - paediatric investigation plan

Ex vivo expanded autologous human corneal epithelium cells containing stem cells

Key facts

• Invented name:
  Holoclar
• Active substance:
  Ex vivo expanded autologous human corneal epithelium cells containing stem cells
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0066/2022
• PIP number:
  EMEA-001082-PIP02-11-M03
• Pharmaceutical form(s):
  Living tissue equivalent
• Condition(s) / indication(s):
  Treatment of limbal stem cell deficiency due to ocular burns
• Route(s) of administration:
  Ophthalmic use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/03/2022
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001082-PIP02-11-M03
• Compliance opinion date:
  21/07/2023
• Compliance outcome:
  Positive

Decision

P/0066/2022 : EMA decision of 11 March 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ex vivo expanded autologous human corneal epithelium cells containing stem cells (Holoclar), (EMEA-001082-PIP02-11- M03)

Adopted Reference Number: EMA/68410/2022