EMEA-002997-PIP01-21 - paediatric investigation plan

Immunoglobulin G1 anti-SORT1 human monoclonal antibody

Key facts

• Active substance:
  Immunoglobulin G1 anti-SORT1 human monoclonal antibody
• Therapeutic area:
  Neurology
• Decision number:
  P/0299/2021
• PIP number:
  EMEA-002997-PIP01-21
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of clinically symptomatic or pre-symptomatic frontotemporal dementia
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  11/08/2021
• Compliance check done:
  No

Decision

P/0299/2021 : EMA decision of 11 August 2021 on the granting of a product specific waiver for immunoglobulin G1 anti-SORT1 human monoclonal antibody (EMEA-002997-PIP01-21)

Adopted Reference Number: EMA/427613/2021