EMEA-000737-PIP02-11-M03 - paediatric investigation plan

afamelanotide

Key facts

• Active Substance:
  afamelanotide
• Therapeutic area:
  Dermatology
• Decision number:
  P/0101/2024
• PIP number:
  EMEA-000737-PIP02-11-M03
• Pharmaceutical form(s):
  • Implant
  • Age-appropriate prolonged release formulation
• Condition(s) / indication(s):
  Treatment of erythropoietic protoporphyria
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/04/2024

Decision

P/0101/2024 : EMA decision of 12 April 2024 on the acceptance of a modification of an agreed paediatric investigation plan for afamelanotide (Scenesse), (EMEA-000737-PIP02-11-M03)

AdoptedReference Number: EMA/98104/2024