EMEA-002875-PIP02-24 - paediatric investigation plan

allogeneic skin-derived ABCB5-positive dermal mesenchymal stromal cells

Key facts

• Invented name:
  Amesanar
• Active substance:
  allogeneic skin-derived ABCB5-positive dermal mesenchymal stromal cells
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  P/0237/2024
• PIP number:
  EMEA-002875-PIP02-24
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of venous leg ulcer
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  18/07/2024
• Compliance check done:
  No

Decision

P/0237/2024: EMA decision of 18 July 2024 on the granting of a product specific waiver for allogeneic skin-derived ABCB5-positive dermal mesenchymal stromal cells (Amesanar), (EMEA-002875-PIP02-24)

Adopted Reference Number: EMA/319282/2024