EMEA-001299-PIP03-17-M02 - paediatric investigation plan

birch bark

Key facts

• Invented name:
  Filsuvez
• Active Substance:
  birch bark
• Therapeutic area:
  Dermatology
• Decision number:
  P/0243/2023
• PIP number:
  EMEA-001299-PIP03-17-M02
• Pharmaceutical form(s):
  Gel
• Condition(s) / indication(s):
  Treatment of epidermolysis bullosa
• Route(s) of administration:
  Cutaneous use
• Contact for public enquiries:

  Amryt Research Limited

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/06/2023

Decision

P/0243/2023 : EMA decision of 16 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for birch bark extract (Filsuvez), (EMEA-001299-PIP03-17-M02)

Reference Number: EMA/273941/2023