EMEA-001299-PIP03-17-M03 - paediatric investigation plan

birch bark

Key facts

• Invented name:
  Filsuvez
• Active substance:
  birch bark
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  P/0541/2023
• PIP number:
  EMEA-001299-PIP03-17-M03
• Pharmaceutical form(s):
  Gel
• Condition(s) / indication(s):
  Treatment of epidermolysis bullosa
• Route(s) of administration:
  Cutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/12/2023
• Compliance check done:
  Ne

Decision

P/0541/2023: EMA decision of 14 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for birch bark extract (Filsuvez), (EMEA-001299-PIP03-17-M03)

Reference Number: EMA/571559/2023