EMEA-002699-PIP01-19-M01 - paediatric investigation plan

bilayer engineered collagen hydrogel-based skin graft composed of autologous keratinocytes and fibroblasts

Key facts

• Active substance:
  bilayer engineered collagen hydrogel-based skin graft composed of autologous keratinocytes and fibroblasts
• Therapeutic area:
  Dermatology
• Decision number:
  P/0331/2023
• PIP number:
  EMEA-002699-PIP01-19-M01
• Pharmaceutical form(s):
  Living tissue equivalent
• Condition(s) / indication(s):
  Treatment of burns
• Route(s) of administration:
  Implant use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/08/2023
• Compliance check done:
  No

Decision

P/0331/2023 : EMA decision of 10 Aug 2023 on acceptance of a modification of an agreed paediatric investigation plan for bilayer, engineered, collagen hydrogel-based skin graft composed of autologous keratinocytes and fibroblasts (EMEA- 002699-PIP01-M01)

Reference Number: EMA/350898/2023