EMEA-002875-PIP01-20 - paediatric investigation plan

allogeneic skin-derived ATP-binding cassette, sub-family B, member 5 (ABCB5)-positive mesenchymal stem cells (allo-APZ2-EB)

Key facts

• Active substance:
  allogeneic skin-derived ATP-binding cassette, sub-family B, member 5 (ABCB5)-positive mesenchymal stem cells (allo-APZ2-EB)
• Therapeutic area:
  Dermatology
• Decision number:
  P/0247/2021
• PIP number:
  EMEA-002875-PIP01-20
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Treatment of epidermolysis bullosa
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  09/07/2021
• Compliance check done:
  No

Decision

P/0247/2021: EMA decision of 9 July 2021 on the agreement of a paediatric investigation plan for allogeneic skin-derived ATP-binding cassette, sub-family B, member 5 (ABCB5)-positive mesenchymal stem cells (allo-APZ2-EB) (EMEA-002875-PIP01-20)

Reference Number: EMA/318167/2021