EMEA-003638-PIP01-24 - paediatric investigation plan

rememulgene arelactibac

Key facts

• Active substance:
  rememulgene arelactibac
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  P/0338/2024
• PIP number:
  EMEA-003638-PIP01-24
• Pharmaceutical form(s):
  Concentrate for cutaneous solution
• Condition(s) / indication(s):
  • Treatment of diabetic foot ulcer
  • Treatment of venous leg ulcer
• Route(s) of administration:
  Cutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  13/09/2024
• Compliance check done:
  No

Decision

P/0338/2024 : EMA decision of 13 September 2024 on the granting of a product specific waiver for rememulgene arelactibac (EMEA-003638-PIP01-24)

Adopted Reference Number: EMA/414280/2024