EMEA-003643-PIP01-24 - paediatric investigation plan

recombinant human progranulin fused to an Fc fragment engineered to contain a human transferrin receptor 1 binding domain (DNL593)

Key facts

• Active substance:
  recombinant human progranulin fused to an Fc fragment engineered to contain a human transferrin receptor 1 binding domain (DNL593)
• Therapeutic area:
  Nervous system disorders
• Decision number:
  P/0361/2024
• PIP number:
  EMEA-003643-PIP01-24
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of frontotemporal dementia
• 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:
  25/10/2024
• Compliance check done:
  No

Decision

P/0361/2024 : EMA decision of 25 October 2024 on the granting of a product specific waiver for recombinant human progranulin fused to an Fc fragment engineered to contain a human transferrin receptor 1 binding domain (DNL593) (EMEA- 003643-PIP01-24)

Adopted Reference Number: EMA/465468/2024